Impella 1000323Recalls & reported problems

Summary

The FDA's MAUDE database contains 943 adverse event reports that list this exact device (DI 00813502012811), received between May 19, 2023 and Sep 30, 2026 — classified as 189 deaths, 438 injuries, 316 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (237 reports).

6 FDA recall records name this device's identifier, 6 still open.

15 other recalls cover devices cleared under the same FDA submission (P170011); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 11, 2026Open, Classified

   A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

   Z-2681-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 27, 2026Open, Classified

   Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

   Z-1470-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Dec 12, 2024Open, Classified

   Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

   Z-0830-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Dec 27, 2023Open, Classified

   IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

   Z-0980-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

5. Dec 27, 2023Open, Classified

   New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

   Z-1074-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

6. Jun 29, 2023Open, Classified

   A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

   Z-2281-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 943 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Remove

  It was reported that the pump was originally pre-closed with per close two times. Upon insertion Abiomed representative instructed the physician that per close was not part of our IFU recommendations. The physician insisted on placing two anyway with acknowledgment of the risks. Upon successful wean and attempt to explant after removal of the repositioning sheath, there was resistance met at the motor housing portion of the pump removal. It was determined by the physician that the per close devices had been tightened around the catheter, and therefore the vein puncture site was not large enough to fit the motor out of the vein. The Abiomed representative was notified and they discussed that the safest option would more than likely be a cut down to remove the pump safely from the patient. Ultimately the physician was able to break the per close knot and remove the pump safely from the patient and removed the pump safely from the patient. No allegations were made against the device or the devices function with the doctor acknowledging that it was the result of the physician tightening the knots. Patient safe and stable at end of procedure. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947993 ↗
• InjurySep 30, 2026Difficult to Remove; Device Sensing Problem

  Product/Patient Demographics/Indication/Baseline Presentation:An Impella RP Flex with SmartAssist was inserted via the right internal jugular vein in a 59 year-old male patient measuring 178 cm in height and weighing 82 kg for a pre-operative indication that was not reported. The patient's clinical condition prior to implantation was reported as Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage A. SCAI Stage A is defined as a hemodynamically stable patient who is not experiencing signs or symptoms of cardiogenic shock but is at risk for its development. Medical history was significant for coronary artery disease (CAD).Device Course & Treatment:On the day following implantation, a Placement Signal Not Reliable alarm was reported. Placement signal, Impella flow, and pulmonary artery pulsatility index (PAPI) were unavailable. The placement signal waveform was not visible on the automated Impella controller (AIC). Pump position was confirmed by imaging, and the device continued to operate without interruption. Echocardiography confirmed appropriate pump position. Activated clotting time (ACT) was reported as maintained throughout support. However, values were

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50946432 ↗
• MalfunctionSep 28, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917953 ↗
• MalfunctionSep 28, 2026Restricted Flow rate; Device Sensing Problem

  The complainant reported that a patient was implanted with an Impella device for mechanical circulatory support. During support, there was a Pulmonary Arterial Pressure Signal (PAPS) increase, and decrease in Impella flow after temporary pacemaker (TPM). Time scale change showed abrupt spike in PAPS and shift down in motor current (MC). No spike observed in MC per registered nurse.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915699 ↗
• InjurySep 25, 2026Pumping Stopped; Device Damaged by Another Device

  Updated Clinical Narrative:An Impella RP Flex with SmartAssist was inserted via the right femoral vein in a 70-year-old femalepatient presenting with acute myocardial infarction complicated by cardiogenic shock (AMI/CGS) classified as Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. SCAI Stage E is defined as refractory shock or actual/impending circulatory collapse in which the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown. Prior to Impella support, the patient was receiving inotropic, vasopressor, respiratory support as well as an Impella CP that was placed approximately 15 minutes prior to the RP implant . A history of cardiopulmonary resuscitation (CPR) was also reported.Following implantation of the Impella RP Flex, a venous access line was being placed for Swan-Ganz catheter insertion. During sheath placement, the treating provider reportedly released control of a microcatheter wire, allowing the wire to migrate intravascularly and become entrained within the Impella RP Flex. It was reported that the wire was not near the pump inlet at the time of the event. The Impella RP Flex was operating as intended at

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896078 ↗
• InjurySep 24, 2026Increase in Pressure

  Clinical Narrative:An Impella RP Flex SmartAssist was inserted percutaneously via right internal jugular vein access site in 78-year-old female patient for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were prior coronary artery bypass graft, coronary artery disease, Diabetes mellitus, renal insufficiency. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage E identified as the body fails to respond to maximal lifesaving therapies. The patient was inotropes, vasopressors, and respiratory support.On day 1 of support, a high purge pressure alarm occurred, and the purge cassette was replaced; however, the alarm persisted. Tissue plasminogen activator (tPA) was added to the purge system. tPA is an off-label use, used in the purge solution to mitigate the impact of biomaterial within the motor. There were no noted clinical adverse events reported due to the addition of tPA in purge. Subsequently, a purge system blocked alarm occurred. The tPA protocol was continued overnight, resulting in resolution of the alarms, after which the purge solution was returned to D5W with 25 mEq

  Patient problems: Thromboembolism

  MAUDE report 50883434 ↗
• MalfunctionSep 24, 2026Device Sensing Problem

  It was reported that a patient implanted with an Impella RP Flex experienced a placement signal not reliable alarm and no flow calculation. The patient condition was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882528 ↗
• InjurySep 22, 2026Restricted Flow rate

  An Impella RP Flex was inserted via the right internal jugular vein in a 61-year-old female with diabetes mellitus who was status post HeartMate 3 left ventricular assist device implantation two days prior to RP Flex placement. The patient had been supported with femoral veno-arterial extracorporeal membrane oxygenation (VA-ECMO), inotropes/vasopressors, and respiratory support and remained with an open chest. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Stage E cardiogenic shock, identified by refractory shock in which the body is failing to respond to maximal lifesaving therapies with progressive end-organ dysfunction.Prior to RP Flex implantation, ultrasound evaluation of the right internal jugular vein and superior vena cava did not identify thrombus. Heparin was administered prior to insertion. Following RP Flex placement, VA-ECMO was decannulated, thereby transitioning the patient from VA-ECMO support to Impella RP Flex support for right ventricular mechanical circulatory support. The RP Flex was temporarily reduced to Performance Level Two (P2) during venous cannula removal, with no change in

  Patient problems: Thromboembolism

  MAUDE report 50853849 ↗
• InjurySep 22, 2026Malposition of Device

  Clinical Narrative:Impella RP Flex with SmartAssist was inserted via the right femoral vein in conjunction with an Impella CP with SmartAssist in a 70-year-old male patient for cardiomyopathy. The patient's comorbidities included coronary artery disease, diabetes mellitus, and a history of coronary artery bypass grafting (CABG). The patient's clinical state prior to initiation of right ventricular support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D, deteriorating shock, defined as worsening hemodynamic instability despite initial therapeutic interventions. Therapies provided prior to Impella RP Flex support included inotropes, vasopressors, and Impella CP support.After two days of biventricular support with Impella CP and Impella RP Flex, the patient was taken to the operating room for planned escalation to Impella 5.5 support and removal of the Impella CP. During preparation for removal of the Impella CP, which was also positioned in the right femoral region, the Impella RP Flex was noted to have migrated from its previously documented position. It was additionally reported that the 23 French introducer sheath used for Impella RP Flex insertio

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852440 ↗
• DeathSep 21, 2026Failure to Advance

  An Impella RP Flex with SmartAssist was attempted via the right internal jugular vein in a 66 year-old female patient presenting post-cardiac arrest with right ventricular failure secondary to pulmonary embolism. The Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage was not reported. No significant past medical history was reported.The patient underwent thrombectomy for pulmonary embolism. A left heart catheterization was performed via radial access, and the left anterior descending (LAD) artery was stented. A right heart catheterization was then performed, and a decision was made to implant an Impella RP Flex device for right ventricular support.A Swan-Ganz catheter was advanced without difficulty, and a guidewire was successfully positioned within the right pulmonary artery. After removal of the Swan-Ganz catheter, the Impella RP Flex was advanced over the guidewire. However, the device was unable to track across the pulmonary valve. Multiple attempts were made to advance the device beyond the valve. During troubleshooting, the physician removed slack from the guidewire and attempted advancement again. Subsequently, the guidewire dropped below the pulmon

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50845898 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemolysis

  MAUDE report 50828963 ↗
• MalfunctionSep 17, 2026Device Sensing Problem

  The complainant reported that the patient was implanted with an Impella RP Flex via percutaneous left femoral vein for mechanical circulatory support. The Impella RP Flex placement signal ¿not reliable¿ alarm occurred once the pump started. A company representative was aware and disabled the audio. The alarm will occasionally resolve but the alarm does return. The physician was aware and was instructed to watch the motor current and flows. They will continue to monitor. The placement signal waveform was not visible on the Automated Impella Controller screen after the issue occurred. The pump's positioning was confirmed via echocardiogram. Target activated clotting time was maintained throughout support. The device was not removed due to the failure. The pump was successfully weaned and then explanted. The patient's outcome at explant was noted as survived. No harm was noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805497 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  An Impella RP Flex was inserted percutaneously via right femoral vein access site in 78-year-old female patient for Pulmonary embolism. The patient¿s comorbidities were coronary artery disease. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage E identified as the body fails to respond to maximal lifesaving therapies. The patient was on inotropes and vasopressors.The patient was receiving anticoagulation therapy with a heparin infusion, monitored by PTT, and the anticoagulation level at the time of the event was reported as supra-therapeutic.On day 1 of support and after transfer to the intensive care unit (ICU), bleeding occurred at the access site around the sheath. The bleeding was managed with manual pressure and placement of a surgical stitch, resulting in resolution of the event. The patient received two units of blood products. The Impella RP Flex remained in place and was not removed due to the reported bleeding event.On day 2 of support, the device was successfully weaned and explanted. The patient survived and was reported as stable.The Impella system was operating as intended at Performan

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50803734 ↗
• DeathSep 17, 2026Restricted Flow rate

  Impella RP Flex SmartAssist was inserted via right femoral vein access in an 83-year-old male patient presenting with acute myocardial infarction and cardiogenic shock. The patient's comorbidity included prior cardiopulmonary resuscitation (CPR). The Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage prior to initiation of support was not documented.Following insertion in the procedure room, the Impella RP Flex SmartAssist was started; however, low flow was immediately observed, and pulmonary artery placement signal was reported to be in the 200 range. Transesophageal echocardiographic assessment demonstrated a decompressed, small left ventricle. Central venous pressure (CVP) decreased from 32 mmHg to 26 mmHg within 5 minutes and subsequently declined to 16 mmHg after an additional 15 minutes. The treating physician assessed the pump as functioning appropriately and suspected the flow readings were not accurately reflecting the patient's condition. The device remained in place, and within approximately 20 minutes the reported flows increased to normal levels. The patient received blood products and fluid resuscitation in an effort to improve preload and hem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802633 ↗
• InjurySep 17, 2026Restricted Flow rate

  An Impella RP Flex with SmartAssist was inserted via the right femoral vein in a 58 year-old male patient with post-operative left ventricular assist device (LVAD) support. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. The patient was additionally receiving inotropic, vasopressor, and respiratory support for hemodynamic management. The patient's medical history was notable for coronary artery disease (CAD), diabetes mellitus (DM), and dialysis dependence.On day 10 of support, an increase in pulmonary artery pressures and a decrease in device flow were reported. No active alarms were observed, and motor current remained stable at baseline. It was reported that the patient remained hemodynamically stable without changes in vasoactive medication requirements. The primary care team suspected intravascular volume depletion as a contributing factor. The patient's central venous pressure (CVP) was reported as low at 8 mmHg, which is below Abiomed's recommended value of 10 mmHg or greater, as the device is preload dependent. Anticoagulation monitoring was performed using partial thromboplastin

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801612 ↗
• MalfunctionSep 16, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796520 ↗
• DeathSep 15, 2026Restricted Flow rate

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50773680 ↗
• MalfunctionSep 15, 2026Device Sensing Problem

  Clinical Narrative:Impella RP Flex SmartAssist was inserted via right internal jugular vein in a 65-year-old male patient presenting with Acute Decompensated Chronic Cardiomyopathy. The patient¿s comorbidities were not documented. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage was not documented. The SCAI Stage at pump insertion was Stage E. Stage E patients have hypoperfusion and organ failure despite numerous interventions according to the SCAI shock algorithm; associated with high mortality.After 2 days of support, the hospital team reported a Placement Signal Not Reliable (PSNR) alarm. No intervention was performed in response to the alarm, and the pump remained and provided hemodynamic support. The PSNR alarm did not result in interruption of support, loss of flow, or other reported adverse clinical consequences.During support, the Impella RP Flex SmartAssist functioned at Performance Level P-7 with flow of 4.2 L/min utilizing 5% dextrose in water with heparin in the purge solution, which is a higher flow than expected.On day 4 of support, a decision was made to withdraw care and the p

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773125 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  An Impella RP Flex SmartAssist was inserted via right femoral vein access in a 48-year-old female patient presenting with acute myocardial infarction and cardiogenic shock. The patient's comorbidities included coronary artery disease and prior coronary artery bypass graft surgery. Prior to initiation of support, the patient was classified as Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E, characterized by hypoperfusion and end-organ dysfunction despite extensive therapeutic intervention and associated with high mortality. Prior to implantation, the patient was supported with inotropes, vasopressors, respiratory support, and extracorporeal membrane oxygenation (ECMO), which served as the primary support modality.On the day following implantation, the medical team identified laboratory evidence of hemolysis with a plasma free hemoglobin level of 600 mg/dL. A repeat plasma free hemoglobin measurement remained elevated at 299 mg/dL. No specific intervention for the reported hemolysis was documented. The patient remained supported with the Impella RP Flex SmartAssist and ECMO and was also receiving dialysis during support.After approximately 36 hours of su

  Patient problems: Hemolysis

  MAUDE report 50740043 ↗
• InjurySep 9, 2026Increase in Pressure

  An Impella RP Flex with SmartAssist was inserted via the right internal jugular vein in a 56 year-old male patient for post-operative cardiothoracic surgery. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. SCAI Stage E is identified as refractory shock or actual/impending circulatory collapse when the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown. The patient was additionally noted to be receiving vasopressors, inotropes, and respiratory support prior to Impella implantation. The patient's medical history was notable for coronary artery bypass grafting (CABG), coronary artery disease (CAD), and diabetes mellitus (DM).Approximately 10 minutes following implantation, a high purge pressure/purge system blocked alarm was reported. Purge flow was reported as decreased at 1.0 mL/hr and purge pressure was reported within range at 1060 mmHg. Troubleshooting included replacement of the purge cassette. However, the condition did not resolve. No purge line tubing kinks were observed. Activated clotting time (ACT) was reported at 326 seconds. Additional contrib

  Patient problems: Thromboembolism

  MAUDE report 50694727 ↗
• InjurySep 9, 2026Increase in Pressure; Device Sensing Problem

  An Impella RP Flex with SmartAssist was inserted via the right femoral vein in a 76-year-old male patient presenting with pulmonary embolism. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. SCAI Stage E is identified as refractory shock or actual/impending circulatory collapse when the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown. The patient was additionally noted to be receiving vasopressor, inotropic, and respiratory support prior to Impella implantation. The patient's medical history was notable for coronary artery disease deep vein thrombosis (DVT). On day 2 of support, a persistent placement signal not reliable alarm was reported on the automated Impella controller (AIC). Echocardiographic imaging confirmed appropriate pump position, and motor current was reported as appropriate for the performance level. Activated clotting time (ACT) management was reported to be maintained throughout support. However, no ACT values were provided during the event. No troubleshooting measures were reported, and device performance metrics were not available on

  Patient problems: Thromboembolism

  MAUDE report 50689968 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Narrative:An Impella RP Flex device was inserted into the right internal jugular vein in a 33-year-old female patient presenting in right heart failure due to cardiomyopathy secondary to myocarditis. Prior to Impella support, the patient was classified as Society for Cardiovascular Angiography & Interventions (SCAI) Stage E shock, indicating that the body was failing to respond to maximal life-saving therapies, leading to full organ shutdown. The patient was receiving multiple inotropes and vasopressors and ventilatory support. The patient's past medical history includes coronary artery disease (CAD). The Impella RP Flex was inserted for right ventricular support as part of Bipella therapy in conjunction with an Impella CP.Upon transfer to a new facility on Day 1 of support, gross hemolysis was reported along with ¿Placement Signal Low¿ alarms. Bedside point-of-care ultrasound (POCUS) was performed, and the Impella RP Flex was retracted approximately 5 cm. Following repositioning, the device waveforms improved. A formal echocardiogram was planned for further evaluation. Despite repositioning, the reported hemolysis did not resolve. No plasma-free hemoglobin and lactate deh

  Patient problems: Hemolysis

  MAUDE report 50689809 ↗
• DeathSep 9, 2026Failure to Advance; Deformation Due to Compressive Stress

  An Impella RP flex was inserted percutaneously via right internal jugular vein access site in a 71-year-old female patient for Post Operative Cardiothoracic Surgery. The patient¿s comorbidities were coronary artery disease, diabetes. The patient¿s clinical state prior to support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage was not reported.During the procedure, a guidewire was utilized and serial pre-dilation was performed. While advancing the Impella RP Flex through the superior vena cava/right atrial junction, resistance was encountered and the catheter continued to kink. The approximate insertion angle was reported as 30 degrees, and excessive force was applied in an attempt to advance the device. The location of resistance was reported as the inferior vena cava. Additional contributing factors included the patient's status as a surgical patient on cardiopulmonary bypass.. The device was explanted 8 minutes after insertion and support was aborted. The patient subsequently expired.The patient subsequently expired. Based on the limited clinical information available, the patient's death is most likely attributable to the underlying cardiac condition a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689735 ↗
• MalfunctionSep 8, 2026Device Sensing Problem

  It was reported that a patient implanted with an Impella 5.5 experienced a placement signal unreliable alarm when the P level was set to 7. Both the placement signal and pump flows were visible and without change. No patient harm was reported. The patient's death is unrelated to the Impella pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668107 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Impella RP Flex was inserted via the left femoral vein in a 60-year-old male patient for acute myocardial infarction/cardiogenic shock (AMI/CGS). The patient's comorbidities were not reported. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D, deteriorating, identified as worsening despite initial therapy with evidence of ongoing hemodynamic compromise. Therapies provided prior to support included inotropes, vasopressors, and respiratory support.Impella RP Flex introducer insertion was initially attempted via the right internal jugular vein using serial dilation insertion best practices. Following unsuccessful advancement of the introducer, a small skin incision was made at the access site in attempt to facilitate sheath passage, however, remained unsuccessful. The healthcare provider attributed the patient's thick skin to the inability to advance the introducer. The left femoral vein was subsequently prepared as alternate access. During preparation for the alternate access site, score marks were observed on the distal end of the sheath dilator, presumed to have resulted from contact with th

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50569136 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170011. One submission often covers many models, so check the product and lot details in each record.

• Z-3149-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella
• Z-3148-2026 · Aug 12, 2026 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella
• Z-3150-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Conn
• Z-2360-2026 · May 14, 2026 · Open, Classified
  Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; P
• Z-2211-2026 · Apr 20, 2026 · Open, Classified
  Automated Impella Controller (AIC); Product Code: 0042-0000-US;
• Z-1589-2026 · Feb 18, 2026 · Open, Classified
  Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5
• Z-1469-2026 · Jan 27, 2026 · Open, Classified
  Impella RP with SmartAssist. Product Code: 0046-0035.
• Z-1471-2026 · Jan 27, 2026 · Open, Classified
  Impella RP. Product Code: 0046-0011.
• Z-0069-2026 · Oct 1, 2025 · Open, Classified
  Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product
• Z-0136-2026 · Sep 16, 2025 · Open, Classified
  Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella
• Z-2164-2025 · Jun 23, 2025 · Open, Classified
  Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella
• Z-0829-2025 · Dec 12, 2024 · Open, Classified
  Impella RP with SmartAssist; Product Number: 0046-0035;
• Z-0636-2024 · Dec 6, 2023 · Open, Classified
  Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
• Z-3251-2026 · Feb 19, 2019 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impe
• Z-2238-2026 · Jan 17, 2011 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impel