Impella 1000550Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00813502013474), received between Oct 15, 2025 and Sep 30, 2026 — classified as 10 deaths, 58 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

19 other recalls cover devices cleared under the same FDA submission (K192769); 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. How this data works · Data updated Oct 13, 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-2683-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP SmartAssist was inserted percutaneously via left femoral access site in 72-year-old male patient for High-Risk Percutaneous Coronary Intervention (HRPCI). The patient¿s comorbidities were renal insufficiency and Dialysis. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage not reported.Device Course & Treatment:During the procedure, bleeding was observed around the 14 Fr peel-away sheath site. It was reported that three vascular access attempts were required prior to sheath insertion, and vessel tenting associated with aggressive intervention was considered a potential contributing factor. The patient's hemoglobin decreased from 7.8 g/dL to 7.0 g/dL, and one unit of packed red blood cells was administered, resulting in a final hemoglobin of 7.7 g/dL. Hemostasis was successfully achieved with two Perclose devices.The Impella CP was explanted following completion of therapy. The patient survived the procedure and was reported with no harm.Additional Factors: History of renal insufficiency and Dialysis. Three vascular access att

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50947783 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  The complainant reported that during a percutaneous coronary intervention (PPCI), the short 14f sheath was bleeding around the site where the single access 7f companion sheath had entered (at 10 o¿clock). The companion sheath was not fully seated and was hanging out of the peel away about 3 inches. Bleeding was stopped with a blue towel that was placed under the 2 sheaths/bleeding site. There was no harm to the patient.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50932059 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50917972 ↗
• InjurySep 28, 2026Use of Device Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 50916411 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  An Impella CP with SmartAssist was inserted via the right femoral artery in an 81 year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (AMI/CGS). The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D. SCAI Stage D is defined as evidence of shock that worsens or fails to improve despite escalation therapies. Prior to Impella support, the patient was receiving vasopressor, inotropic, and respiratory support. Medical history was significant for cardiac arrest requiring extracorporeal cardiopulmonary resuscitation (eCPR). Height was not reported, and the patient weighed 98 kg.During implantation, the Impella CP was initially inserted via the right femoral artery. Following placement of the repositioning sheath, a large hematoma developed at the access site. The physician elected to remove the Impella device and place a 14 French x 25 cm sheath, after which the Impella was reinserted and restarted. Due to ongoing bleeding, angiography was performed and a vascular surgeon was consulted. The surgeon accessed the vasculature from the left femoral artery acce

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50914291 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia

  MAUDE report 50914168 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  An Impella CP was inserted percutaneously via right femoral artery access site in 51-year-old male patient for High-Risk Percutaneous Coronary Intervention (HRPCI). 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 was not reported.During the percutaneous coronary intervention procedure, the patient experienced cardiac arrest requiring three defibrillation shocks. During defibrillation, the patient moved on the procedure table, resulting in the development of a groin hematoma at the access site. At the conclusion of the procedure, the Impella CP was removed, and vascular closure was performed using one Angio-Seal and two Perclose devices with reported good hemostasis. The patient expired approximately three hours after insertion and at the time of explant.Impella performance (P) level was not reported.The groin hematoma occurred when the patient moved during defibrillation following cardiac arrest and was associated with procedural and patient-related circumstances. There was no allegation or evidence suggesting that the Impella CP or introd

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50889311 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Impella CP SmartAssist was inserted via a 14 Fr introducer at femoral artery access of undocumented side in a 74-year-old female patient presenting with acute myocardial infarction and cardiogenic shock. The patient's comorbidities were not documented. The patient's clinical condition prior to initiation of support was not reported according to the Society for Cardiovascular Angiography and Interventions (SCAI) Shock classification.During insertion utilizing the Abiomed-provided 14 Fr introducer, vascular injury occurred. The external iliac artery was reported to have developed bleeding and an associated hematoma. The severity of the vascular injury required surgical repair by the vascular surgery team; however, the extent and details of the surgical intervention were not reported. Following identification of the vascular complication, the 14 Fr introducer was peeled away and Impella support was aborted. No information was provided regarding placement of an alternative mechanical circulatory support device.No pump performance data, anticoagulation information, or Activated Clotting Time (ACT) values were reported, as the pump was not placed into clinical support.The patient survive

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemia

  MAUDE report 50886311 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  An Impella CP with SmartAssist device was inserted into the right femoral artery in an 75-year-old male patient as a bailout of a percutaneous coronary intervention (PCI) of the right coronary artery (RCA). Prior to Impella support, the patient was classified as Society for Cardiovascular Angiography and Intervention (SCAI) Stage D shock, indicating deterioration despite escalation of therapy. The patient was receiving multiple inotropes, vasopressors, and ventilatory support. The patient's medical history was significant for coronary artery disease (CAD), dialysis, and cardiac arrest requiring cardiopulmonary resuscitation (CPR).The Impella CP was implanted as bailout support and was intended to remain in place following completion of the PCI procedure. After removal of the 14 French long peel-away sheath and insertion of the repositioning sheath, fluoroscopic imaging demonstrated an iliac artery perforation. In response to the event, the Impella device was weaned and explanted. Vascular surgery was consulted and performed repair of the injured vessel.Subsequent review of the procedure identified that the 14 French long sheath had been inserted over a standard J-wire rather than a

  Patient problems: Perforation of Vessels

  MAUDE report 50754010 ↗
• DeathAug 31, 2026Use of Device Problem

  Impella CP was inserted via the left femoral artery in a 61-year-old female patient for an unknown indication. The patient's comorbidities were not reported. The patient's clinical presentation included out-of-hospital cardiac arrest. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E, identified as refractory shock with actual or impending circulatory collapse when the body fails to respond to maximal life-saving therapies, leading to full organ shutdown. Upon initiation of Impella support, the patient was receiving inotrope therapy, vasopressor therapy, and respiratory support.Following insertion, the 14 French sheath was left in place and the patient was transferred to the Intensive Care Unit (ICU). It was reported the patient required continued administration of vasoconstrictive medication, despite the addition of Impella support. While in the ICU, diminished distal pulses in the left lower extremity were reported. A distal limb perfusion (DLP) catheter was placed the following day, resulting in restoration of distal perfusion. Anticoagulation monitoring was performed using partial thromb

  Patient problems: Ischemia

  MAUDE report 50519108 ↗
• DeathAug 25, 2026Use of Device Problem

  An Impella CP was inserted percutaneously via right femoral artery access site in a 64-year-old male patient for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were coronary artery disease, renal insufficiency, Peripheral Artery Disease (PAD) and Peripheral Vascular Disease (PVD). The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage SCAI Shock Stage E identified as the body fails to respond to maximal lifesaving therapies. The patient was on inotropes, vasopressors and respiratory support. The patient was on concurrent extracorporeal Membrane Oxygenation (ECMO) as the primary hemodynamic support device with the Impella in place to vent the left ventricle.During/after introducer insertion, the patient developed right lower limb ischemia, diagnosed by loss of pulses in the affected extremity. Due to severe coagulopathy and active bleeding concerns, including reported ACT >800 seconds, INR 17, and hemoglobin 5.8 g/dL, the implanting physician elected not to peel away the 14 French introducer because of concerns for worsening bleeding in a heavily calcified vessel. Attempts to

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 50433683 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50236342 ↗
• DeathAug 12, 2026Patient Device Interaction Problem

  An Impella CP device was inserted via the femoral artery in a 56 year-old male patient with an indication not reported. The access side was reported as unknown. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. The patient's medical history was not reported.During support, a hematoma developed at the Impella access site around the repositioning sheath. Hemostasis was achieved by manual pressure. It was reported that the repositioning sheath was properly placed with angle matching. No further intervention or treatments were reported. The anticoagulation status prior and during support was also not reported. It was noted that the patient did require the hemodynamic support with the use of 3 vasopressor and inotropes during support. The following morning the patient subsequently expired on support.While on support, the Impella CP device operated at performance level 8 with expected flows of 3.2 liters/minute. The purge solution consisted of dextrose 5% in water with 25 milliequivalents per liter Sodium Bicarbonate.The reported hematoma and access site bleeding cannot be dissociated from the Im

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50229587 ↗
• InjuryAug 7, 2026Patient Device Interaction Problem

  Impella CP was inserted via the right femoral artery in a 56-year-old male patient for acute myocardial infarction complicated by cardiogenic shock. The patient's comorbidities included coronary artery disease. The patient's clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E (extremis), indicating hypoperfusion and organ failure despite numerous interventions. Prior to Impella support, the patient was reported to be receiving inotropes, vasopressors, and respiratory support.During support, while the 14F peel away was still indwelling, angiography demonstrated that the Impella CP was partially occlusive. The 14 French peel-away sheath was removed outside of the body, and the repositioning sheath was advanced. Due to concerns regarding perfusion while the 14 French peel-away sheath was in place, a decision was made to place an antegrade sheath in the right superficial femoral artery and an arterial donor line from the left common femoral artery to create an external arterial bypass. Following the intervention, pulses were present in the right lower extremity on the Impella access side with clear evidence of

  Patient problems: Ischemia

  MAUDE report 50174305 ↗
• InjuryAug 7, 2026Failure to Advance

  Clinical Narrative:Impella CP was inserted (side not reported) in a patient (Gender and age not reported) presenting with unknown indication. The patient¿s comorbidities were Peripheral Artery Disease (PAD) and Peripheral Vascular Disease (PVD) . The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage was not reported.A sheath insertion was unsuccessful due to patient anatomy. A guidewire was utilized, serial pre-dilation was performed, the approximate insertion angle was reported as 45°, and no excessive force was applied during the procedure. The vessel diameter was reported as ¿4 mm for CP use. The procedure was aborted. A replacement sheath was placed, and no delivery issues were encountered. No patient harm was reported.The reported inability to insert the sheath was attributed to patient anatomy and underlying vascular conditions (PAD/PVD) rather than a device-related issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174004 ↗
• InjuryAug 6, 2026Patient Device Interaction Problem; Difficult or Delayed Separation

  Clinical Narratives:An Impella CP device was placed via the right femoral artery in a 72 year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (AMI/CGS). The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage C. The patient was additionally noted to be receiving vasopressors and inotropes for hemodynamic support. The patient¿s medical history was not reported.During the removal of the 14 French peel away sheath, bleeding was observed while splitting the sheath. It was reported that the sheath may have not been completely removed from the body prior to the splitting, which is not an Abiomed recommendation, as it can contribute to vessel damage. Significant pump movement was reported during the removal process. An attempt was made to achieve hemostasis utilizing a side-closure technique with the repositioning sheath in place. A single PerClose closure device was deployed. However, the sutures did not adequately engage the vessel, and the suture material was completely withdrawn from the patient while the knot was being tightened. Resistance was reported du

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 50157564 ↗
• InjuryAug 5, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  An Impella CP was inserted via the left femoral artery in a 79-year-old male patient with a history of prior coronary artery bypass graft (CABG) surgery and coronary artery disease (CAD) for protected percutaneous coronary intervention (PCI). Comorbidities beyond coronary artery disease were not reported. The patient's clinical state prior to initiation of support, including the Society for Cardiovascular Angiography and Interventions (SCAI) shock stage, was not reported.During implantation, the Impella CP was inserted and the guidewire was removed. After initiation of support, the pump was noted to be entangled in the mitral valve apparatus. The device was removed, rewired, and reinserted. Following confirmation of appropriate position, the guidewire was removed and support was restarted. Bleeding was subsequently observed from the hemostatic valve around the Impella catheter. Due to the severity of the bleeding, the physician elected to remove the device and replace the 14 French × 25 cm introducer sheath with a new 14 French × 25 cm introducer sheath from another kit. The Impella CP was then inserted a third time and successfully positioned without further issues. Single-site ac

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50142461 ↗
• InjuryAug 4, 2026Patient Device Interaction Problem

  Clinical Narrative:An Impella CP was inserted via femoral access site (side unspecified) in a patient (unknown gender and age) for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities included pre-existing peripheral artery disease (PAD). The patient¿s clinical state prior to initiation of support SCAI (Society for Cardiovascular Angiography and Interventions) shock stage is unknown.During support, the patient developed clinically significant leg ischemia. Given the presence of pre-existing PAD, this condition was considered a relevant contributing risk factor. As a result of the ischemic complication, the Impella CP was explanted.

  Patient problems: Ischemia

  MAUDE report 50127053 ↗
• InjuryJul 31, 2026Crack; Fluid/Blood Leak; Patient Device Interaction Problem

  Impella CP was inserted via the 14French introducer in a 72-year-old male patient presenting with Acute Myocardial Infarction and Cardiogenic Shock. The patient¿s comorbidities were not shared. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage C. The patient was additionally supported by inotropes and vasopressors.The 14French introducer was used in combination with a 7French companion for a single access insertion at the right femoral. All best practices were followed for vessel access. During the insertion of the 7 French Companion sheath through the 14 French sheath the hemostatic valve tore which led to a leak/bleed preventing single access. The interventional sheath was therefore moved to the contralateral leg, at the left femoral artery without noted incident.While on support the the Impella CP functioned and supported for just under one day at, Performance Level P-7 with 2.7L/min flow with 5% Dextrose in water with sodium bicarbonate in the purge solution. The device was successfully weaned and explanted.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50101724 ↗
• InjuryJul 31, 2026Fluid/Blood Leak; Material Integrity Problem; Patient Device Interaction Problem

  An Impella CP was inserted via left femoral artery in a 59-year-old male patient presenting with Acute Myocardial Infarction complicated with Cardiogenic Shock. The patient¿s comorbidities were not shared. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. Prior to insertion of the Impella the patient was supported by inotropes, vasopressors and was on respiratory support. The primary hemodynamic support device was Extra Corporeal Membrane Oxygenation (ECMO) and the Impella CP was placed for left ventricular venting.The Impella CP was inserted and single access was attempted with the 7 French Companion Sheath. There was extensive bleeding noted at the hub of the 14 French peel away introducer around the 7 French Companion Sheath that was thought to be due to the angle the physician was manipulating the device as they were working from the opposite side of the table and the bleeding subsided when the alignment of the two sheaths was corrected. The procedure lasted approximately 3 hours and the patient did require a blood transfusion along with 5 liters of sodium chloride.While on support the

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50101604 ↗
• InjuryJul 30, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  Clinical Narrative:Impella CP was planned for insertion via the right femoral artery in a 66-year-old male patient undergoing Protected Percutaneous coronary intervention (PPCI). The patient¿s comorbidities were not reported. The patient¿s clinical state prior to initiation of support was not reported.During preparation for Impella CP insertion, after placement of the 14 French introducer sheath, bleeding was observed from the hemostatic valve. The introducer sheath was exchanged prior to Impella CP insertion. There were no reports of hemodynamic instability, transfusion requirement, blood product administration, or additional clinical complications associated with the event.Following sheath exchange, the Impella CP was successfully inserted and provided circulatory support as intended. No device performance concerns were reported with the Impella CP.Based on the available information, the bleeding was limited to the introducer sheath hemostatic valve and was resolved with sheath replacement.The event is conservatively reported as a device revision/replacement due to introducer sheath performance not as expected. The reported minor bleeding did not require blood products or additio

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50084239 ↗
• InjuryJul 27, 2026Use of Device Problem; Patient Device Interaction Problem

  The Impella CP was inserted via a 14Fr introducer at the left femoral artery to support the 65 year old male patient who had been admitted in with Acute Myocardial Infarction and Cardiogenic Shock (CGS). The patient's presentation per documentation was Society for Cardiovascular Angiography and Interventions (SCAI) Stage D Shock at pump insertion. Underlying medical history and comorbidities were not shared. Prior to the pump insertion the patient was supported by inotropes, vasopressors, and respiratory support.The CP was inserted via the 14Fr introducer, but they did not follow best practices and remove the introducer. The introducer was retained within the femoral artery and the patient was then transferred to the tertiary medical center. On the day of implant the team observed the urine color to change and was noted as "red". The hematuria prompted the team to assess pump positioning with echo imaging. The pump was noted to be in correct position. The team also determined the volume to be appropriate. These findings prompted the team to question if the patient was in Right Ventricle failure in addition to the CGS. Per the Flow Chart the right sided hemodynamics were elevated wi

  Patient problems: Vascular Dissection

  MAUDE report 50045724 ↗
• InjuryJun 9, 2026Fluid/Blood Leak

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 83-YEAR-OLD FEMALE PATIENT FOR PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED, AND THE CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS NOT PROVIDED. A 14 FRENCH INTRODUCER SHEATH WAS UTILIZED FOR DEVICE PLACEMENT. DURING THE PROCEDURE (TOWARDS THE END OF THE CASE), THE PATIENT DEVELOPED SUDDEN HYPOTENSION TOWARD THE END OF THE CASE. UPON FURTHER ASSESSMENT, THE MANAGING PHYSICIAN IDENTIFIED FLUID LEAKAGE NEAR THE PEEL-AWAY SHEATH AND COMPANION SHEATH, WITH ESTIMATED BLOOD LOSS OF APPROXIMATELY 500 ML. THE PATIENT SURVIVED TO EXPLANT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25442796 ↗
• InjuryJun 8, 2026Crack; Patient Device Interaction Problem

  A 77-YEAR-OLD MALE UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) SUPPORTED WITH AN IMPELLA CP INSERTED VIA PERCUTANEOUS RIGHT FEMORAL ARTERIAL ACCESS. DURING THE PROCEDURE, EXTENSIVE BLEEDING WAS NOTED AROUND THE IMPELLA SHEATH, WITH A CORRESPONDING HEMOGLOBIN DECREASE FROM 15.9 TO 14.4. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, ALERT AND ORIENTED, AND WAS SUPPORTED WITH DOPAMINE. THE INTRODUCER WAS REPORTED TO HAVE A SPLIT NOTED AT THE TIP AND WAS IDENTIFIED AS DAMAGED; THE DEVICE WAS REMOVED. THE PATIENT SURVIVED THE PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME; FURTHER EVALUATION OF THE RETURNED PRODUCT IS PENDING. THE PATIENT SURVIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25430194 ↗
• InjuryJun 8, 2026Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 87-YEAR-OLD MALE PATIENT WHO PRESENTED FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). THE PATIENT¿S MEDICAL HISTORY WAS SIGNIFICANT FOR CORONARY ARTERY DISEASE WITH MULTI-VESSEL INVOLVEMENT AND CARDIOPULMONARY RESUSCITATION. THE PATIENT HAD A REPORTED LACTATE OF 5.2 MILLIMOLES PER LITER AND WAS RECEIVING AMIODARONE AND VASOPRESSOR/INOTROPIC THERAPY. THE PATIENT WAS ADDITIONALLY SUPPORTED WITH VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS INITIALLY REPORTED AS SCAI SHOCK STAGE A; HOWEVER, BASED ON THE PRESENCE OF ELEVATED LACTATE, THE REQUIREMENT FOR VASOACTIVE THERAPY, AND THE NEED FOR CONCOMITANT MECHANICAL CIRCULATORY SUPPORT, THE CLINICAL PRESENTATION IS MORE CONSISTENT WITH SCAI SHOCK STAGE E. FOLLOWING IMPELLA CP INSERTION, DECREASED PERFUSION TO THE ACCESS LIMB WAS REPORTED. IT WAS ALSO NOTED THAT THE 14 FRENCH PEEL-AWAY SHEATH WAS LEFT IN PLACE POST-IMPLANTATION, WHICH IS OUTSIDE OF RECOMMENDED USE AND MAY INCREASE THE RISK OF ACCESS SITE-RELATED ADVERSE EVENTS, INCLUDING COMPROMISED DISTAL LIMB PERFUSION. THE IMPELLA

  Patient problems: Ischemia

  MAUDE report 25429949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192769. One submission often covers many models, so check the product and lot details in each record.

• Z-2686-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and acces
• Z-2692-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2682-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
• Z-2689-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
• Z-2688-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2684-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
• Z-2690-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
• Z-2685-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and acces
• Z-2687-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2681-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
• Z-2693-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
• Z-2691-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
• Z-0647-2024 · Nov 7, 2023 · Open, Classified
  Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
• Z-0646-2024 · Nov 7, 2023 · Open, Classified
  Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (
• Z-0649-2024 · Nov 7, 2023 · Open, Classified
  Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella C

…and 4 more.