Impella 1000080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,084 adverse event reports that list this exact device (DI 00813502012279), received between Apr 6, 2023 and Sep 30, 2026 — classified as 987 deaths, 3,111 injuries, 986 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (778 reports).

7 FDA recall records name this device's identifier, 7 still open.

19 other recalls cover devices cleared under the same FDA submission (P140003); 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-2682-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. May 18, 2026Open, Classified

   Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

   Z-2457-2026 · Root cause: Under Investigation by firm · FDA record ↗

3. Aug 5, 2024Open, Classified

   A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

   Z-2964-2024 · Root cause: Under Investigation by firm · FDA record ↗

4. May 31, 2024Open, Classified

   Nine (9) Impella CP pumps failed inspection and were inadvertently released.

   Z-2319-2024 · Root cause: Release of Material/Component prior to receiving test results · 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 · FDA record ↗

6. 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 · FDA record ↗

7. Jun 14, 2023Open, Classified

   There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

   Z-2116-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 5,084 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Ischemia

  MAUDE report 50955044 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemolysis; Renal Failure

  MAUDE report 50954936 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia

  MAUDE report 50949742 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  The complainant reported that a patient was implanted with an Impella CP via percutaneous left femoral artery for mechanical circulatory support. Placement signal not reliable was reported on the Automated Impella Controller (AIC) screen. The placement signal waveform was not visible on the AIC screen after the issue occurred. The pump's position was confirmed via echocardiogram. The procedure was successful with this device. The device was not removed due to the failure. The patient remains on support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949332 ↗
• MalfunctionSep 30, 2026Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948926 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemolysis; Ischemia

  MAUDE report 50948624 ↗
• InjurySep 30, 2026Failure to Advance

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50948527 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP SmartAssist was inserted percutaneously via right femoral access site in 53-year-old male patient (weight 89 kilograms) for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were coronary artery disease (CAD). The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage C identified as clinical evidence of hypoperfusion that initially requires pharmacological or mechanical support. The patient was on inotropes, vasopressors and respiratory support.Device Course & Treatment:On day 2 of support, the patient developed pink-tinged urine, which was reported as hematuria. Imaging confirmed appropriate pump position and no anatomical abnormalities of the heart were reported. The pump was repositioned in response to the event, after which the pink-tinged urine resolved. There was no reported infusion of blood products, no reported contact of the pump with the mitral apparatus, and no reported organ damage.On day 3 of support, the device was explanted following successful weaning. The patient survived to explant and w

  Patient problems: Hematuria

  MAUDE report 50946618 ↗
• MalfunctionSep 30, 2026Device Damaged by Another Device; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946323 ↗
• MalfunctionSep 29, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938286 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP with SmartAssist was insertion via the right femoral artery in a 52-year-old female patient presenting with acute myocardial infarction complicated by cardiogenic shock (AMI/CGS). Prior to the intended procedure, the patient's clinical condition was 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 device implantation, the patient was receiving vasopressor, inotropic, and respiratory support. The patient experienced cardiac arrest prior to device implantation. The patient's medical history, height, and weight were not reported.Device Course & Treatment:During implantation, due to the urgency of establishing hemodynamic support and while the patient was experiencing recurrent ventricular fibrillation requiring multiple defibrillation shocks, the physician determined that it would take too long to backload the device without the red easy guide lumen. During the implantation pr

  Patient problems: Cardiac Arrest

  MAUDE report 50937427 ↗
• DeathSep 29, 2026Malposition of Device

  An Impella CP SmartAssist was inserted percutaneously via right femoral access site in 62-year-old male patient (weight 72 kilograms and height 165cm) for Cardiomyopathy. The patient¿s comorbidities were coronary artery disease (CAD), diabetes mellitus, Renal insufficiency and dialysis. 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. Concurrent Continuous Renal Replacement Therapy (CRRT). The patient was on inotropes, vasopressors and respiratory support.Device Course & Treatment:On day 3 of support, hospital staff reported that the patient became delirious and moved during support, resulting in the Impella catheter being pulled back. Subsequently, Impella in Aorta alarms were observed, and bleeding was noted at the groin access site. Transthoracic echocardiography reportedly confirmed that the pump had migrated completely out of the left ventricle and into the aorta. Hospital personnel contacted Abiomed for clinical guidance regarding management of the bleeding and potential administration of protamine and platelets. They

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50936618 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Product/Patient Demographics/Indication/Baseline Presentation:Impella CP with SmartAssist was inserted percutaneously via the left subclavian/axillary artery to provide left ventricular support in conjunction with an Impella RP Flex with SmartAssist for biventricular support in a 60-year-old female patient (158 cm, 78 kg) presenting with acute myocardial infarction complicated by cardiogenic shock. Relevant comorbidities included renal insufficiency and peripheral vascular disease. Prior to support initiation, the patient was in Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E (Extremis), defined as refractory cardiogenic shock with actual or impending circulatory collapse despite maximal lifesaving therapies. The patient required high-dose vasopressor therapy, inotropic support, and respiratory support.Device Course & Treatment:On day 4 of support, absent distal pulses were identified in the left upper extremity distal to the subclavian access site, consistent with limb ischemia. Despite this finding, support was continued due to the severity of the patient's condition and lack of alternative therapeutic options. Over the following 4 days, intermittent

  Patient problems: Ischemia

  MAUDE report 50933175 ↗
• InjurySep 29, 2026Malposition of Device

  Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP SmartAssist was inserted percutaneously via right femoral access site in 47-year-old male patient (weight 106 kilograms and height 182 cm) for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were not reported. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage B identified as clinical evidence of hemodynamic instability, including but not limited to, hypotension, tachycardia, or abnormal systemic hemodynamics without hypoperfusion.Device Course & Treatment:During Impella support, the patient developed hematuria with laboratory findings consistent with hemolysis, including plasma free hemoglobin of 298 mg/dL and LDH of 2085 U/L. Urine was noted to be pink/red-tinged. Imaging assessment was performed and demonstrated that the pump was positioned too deep within the ventricle. The device was repositioned, after which both the hemolysis and hematuria resolved and the urine cleared. No anatomic abnormalities of the heart were reported, and the pump was not reported to be in contact with the mitral valv

  Patient problems: Hematuria

  MAUDE report 50932960 ↗
• InjurySep 29, 2026Restricted Flow rate; Malposition of Device

  An Impella CP with SmartAssist was inserted via the right femoral artery in a 51 year-old female patient presenting with acute myocardial infarction complicated by cardiogenic shock (AMI/CGS). Prior to initiation of support, the patient's clinical condition was classified as 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 placement, the patient was receiving vasopressor and inotropic support. The patient's medical history was significant for coronary artery disease (CAD). The patient measured 152 cm in height and weighed 63 kg.Device Course & Treatment:During transfer from the catheterization laboratory table to the gurney, a sudden reduction in Impella flow was reported. While operating at performance level 8, flow decreased from approximately 3.5 L/min to 0.6 L/min and continuous suction was observed with separation of the aortic and left ventricular waveforms. Initial assessment considered possible causes including thrombus, malposition, or an Automated Impella Controller (AIC) issue. The AIC was exchanged, and fluoroscopic a

  Patient problems: Hematuria

  MAUDE report 50932812 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP SmartAssist was inserted percutaneously via right femoral access site in 68-year-old male patient (weight 120 kilograms and height 185 cm) for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were Prior Cardiopulmonary resuscitation (CPR). 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.Device Course & Treatment:During Impella support, the patient developed suspected hemolysis manifested by red/tinged urine. Hemolysis began while on support and was diagnosed based on urine discoloration; however, no laboratory values, including plasma free hemoglobin, were provided. Imaging and echocardiography confirmed appropriate pump position during the event, with no evidence of pump contact with the mitral apparatus and no reported suction events. The patient remained on P-9 support and was unable to be weaned. Additional clinical findings included renal failure requiring continuous renal replacement therapy (CRRT), shock liver, card

  Patient problems: Hematuria; Hemolysis; Renal Failure

  MAUDE report 50932629 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Narrative:Product/Patient Demographics/Indication/Baseline Presentation:Impella CP SmartAssist (SA) was inserted via right femoral artery access in a 68-year-old female patient weighing 72 kg who presented with acute myocardial infarction and cardiogenic shock. The patient's comorbidities were not reported. Prior to initiation of support, the patient was classified as Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage C, indicating hypoperfusion requiring intervention beyond volume resuscitation. Before Impella implantation, the patient was supported with an intra-aortic balloon pump (IABP).Device Course & Treatment:The Impella CP SmartAssist was implanted through the same femoral access site previously utilized for IABP support. Following exchange of the guidewire, dilator, introducer, and IABP device, the Impella CP SmartAssist was successfully delivered and coronary angioplasty was performed with Impella support. A femoral angiogram was not performed prior to device insertion. Following removal of the 14 French peel-away introducer and advancement of the 13 French repositioning sheath, the patient developed an access site hematoma.Management of

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50931353 ↗
• InjurySep 29, 2026Break; Malposition of Device

  Updated clinical narrative:Additional information received from the field representative stating the previously reported concern of limb ischemia to the contralateral side was incorrect. The concern was to the left leg which was the Impella access side. It was reported that the pulses to the left leg were able to be heard via doppler and that no interventions were required. Additionally, the representative confirmed that the device was not repositioned due to the reported concern that the Impella catheter was fractured.Prior Clinical Narrative:Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP with SmartAssist was inserted via the left femoral artery in a 63 year-old female patient with acute-on-chronic decompensated cardiomyopathy. The patient¿s clinical condition prior to initiation of support was classified as 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 inotropic, vasopressor, and respiratory support. The patient¿s medical history was significant for coronary art

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50931320 ↗
• InjurySep 28, 2026Malposition of Device; Device Sensing Problem

  Patient problems: Cardiac Arrest

  MAUDE report 50923491 ↗
• InjurySep 28, 2026Malposition of Device

  Demographics/Indication/Baseline Presentation:An Impella CP SmartAssist was inserted percutaneously via left femoral access site in 70-year-old, female patient height 152 cm, weight 86 kilograms for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were coronary artery disease and diabetes mellitus. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography Intervention (SCAI) Shock Stage A identified as hemodynamically stable patient who is not experiencing signs or symptoms of cardiogenic shock but is a risk for its development. The patient was on inotropes, vasopressors and respiratory support.Device Course & Treatment:On the day of implantation, the patient became restless and moved extensively in bed without knee immobilization in place. The Impella CPSA became entangled in the patient's feet and was inadvertently pulled back into the descending aorta. The physician on call was notified and, due to the patient's stable hemodynamic status, advised delaying intervention until the following morning. Upon evaluation, the anti-contamination sleeve was noted to have been pulled loose from the repositioning sheath;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922824 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Narrative:An Impella CP SmartAssist was inserted percutaneously via right femoral access site in 58-year-old, female patient height 165 cm, weight 78 kilograms for Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were diabetes mellitus. 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, vasopressors, and respiratory support.On day 1 of support, bilateral lower extremity ischemia manifested as loss of pulses and was reported to have occurred during/after repositioning unit insertion. Contributing factors included severe calcified superficial femoral artery disease, underlying PAD/PVD, and very high vasopressor requirements. Imaging of the affected vessel was available. In response, an external arterial bypass was established from a donor left common femoral artery 6 Fr sheath to an antegrade right superficial femoral artery 6 Fr sheath. No device malfunction or damage was identified. The event was assessed as patient injury of limb ischemia, and the injury was a

  Patient problems: Ischemia

  MAUDE report 50922707 ↗
• InjurySep 28, 2026False Alarm; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921628 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 50921618 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia; Thromboembolism

  MAUDE report 50919075 ↗
• InjurySep 28, 2026Device Sensing Problem

  Clinical Narrative:Product/Patient Demographics/Indication/Baseline Presentation:An Impella CP with SmartAssist was inserted via the left femoral artery in a 63 year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (AMI/CGS). The patient¿s clinical condition prior to initiation of support was classified as Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. SCAI Stage E is defined as refractory shock or actual or 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 vasopressor, inotropic, and respiratory support. The patient¿s medical history was significant for coronary artery disease (CAD). The patient measured 183 cm in height and weighed 88 kg.Extracorporeal membrane oxygenation (ECMO) was initiated after Impella CP placement on the day of implantation. ECMO is the primary hemodynamic support device with the Impella being utilized for left ventricular venting.Device Course & Treatment:On day 3 of support, nursing staff reported that pulses had been lost in both the ECMO-cannulate

  Patient problems: Ischemia

  MAUDE report 50918098 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140003. 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-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-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-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-1591-2026 · Feb 16, 2026 · Open, Classified
  Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Contr
• Z-1030-2026 · Dec 4, 2025 · Open, Classified
  Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
• 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-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-0440-2024 · Oct 10, 2023 · Terminated
  Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
• Z-0441-2024 · Oct 10, 2023 · Terminated
  Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
• Z-1590-2023 · Apr 17, 2023 · Open, Classified
  Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (

…and 4 more.