Impella 1000100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,093 adverse event reports that list this exact device (DI 00813502012828), received between Jan 18, 2023 and Sep 30, 2026 — classified as 848 deaths, 3,211 injuries, 2,034 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (769 reports).

5 FDA recall records name this device's identifier, 5 still open.

20 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. Dec 4, 2025Open, Classified

   Device packaged in incorrect outer box carton.

   Z-1030-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. 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-2965-2024 · Root cause: Under Investigation by firm · FDA record ↗

3. 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 ↗

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 · FDA record ↗

5. 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-2114-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 6,093 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951662 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50950903 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 50948963 ↗
• InjurySep 30, 2026Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948875 ↗
• MalfunctionSep 30, 2026False Alarm; Device Sensing Problem

  The complainant reported that a patient was implanted with an Impella 5.5 via right surgical axillary/subclavian artery for mechanical circulatory support. The patient¿s registered nurse (RN) called to say that the patient kept getting Impella in aorta and Impella position unknown alarms then resolving. They did an echocardiogram and the device position looked good per the team. The patient¿s RN stated no drops in flows, changes in blood pressure, or loss of pulsatility when the alarms occur. The medical doctor made the decision to disable placement signal alarms. The patient's outcome was stable. The patient remains on support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948773 ↗
• MalfunctionSep 30, 2026Device Damaged by Another Device; Device Sensing Problem

  It was reported that, during shockwave of the left main, the placement signal dashed out and then the placement signal was not reliable. The patient was indicated to be on support and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947837 ↗
• InjurySep 30, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947257 ↗
• MalfunctionSep 30, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946760 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  It was reported that there was condensation noted within the purge sidearm. The device was dry to the exterior and the staff reportedly felt like it was dripping before. The purge tubing connection to leur lock was secured. The patient was indicated to have been in stable condition and no patient harm was noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946599 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937926 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937348 ↗
• MalfunctionSep 29, 2026False Alarm; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937170 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemolysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50934106 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Updated Clinical Narrative: (Additional information received by the field representative).Following the reported hemorrhagic stroke, additional information indicated the patient developed disseminated intravascular coagulation (DIC) with diffuse bleeding from multiple sites. The family subsequently elected to withdraw care, and the patient expired. However, the timing of death relative to the hemorrhagic stroke was not reported. Based on the available information, the reported hemorrhagic stroke cannot be ruled out as being associated with Impella 5.5 support, as it occurred following explant of the device. Additional contributing factors include multiple mechanical circulatory devices utilized, heart transplantation procedure, and the reported development of DIC with diffuse bleeding.Prior Clinical Narrative:Product/Patient Demographics/Indication/Baseline Presentation:An Impella 5.5 with SmartAssist was inserted via the right axillary artery in a 47 year-old male patient measuring 185 cm in height and weighed 90 kg with cardiomyopathy presenting in Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage C. SCAI Stage C is defined as clinical evidence of cardio

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 50933221 ↗
• MalfunctionSep 29, 2026Increase in Pressure; Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931388 ↗
• InjurySep 29, 2026Increase in Pressure

  Additional information was received which indicated that the TPA did resolve the high pressure purge alarm. The reporter indicated that an attempt would be made to return the pump to the manufacturer to aid in the investigation after the device was explanted.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thromboembolism

  MAUDE report 50931188 ↗
• InjurySep 29, 2026Restricted Flow rate; Malposition of Device

  Clinical Narrative:Product/Patient Demographics/Indication/Baseline Presentation:An Impella 5.5 with SmartAssist (SA) was inserted via the right axillary/subclavian artery in a 65-year-old male weighing 87 kg who presented with acute myocardial infarction complicated by cardiogenic shock. The patient's medical history was significant for coronary artery disease, cardiac arrest, and prior cardiopulmonary resuscitation (CPR). The patient's clinical condition prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D. Stage D patients demonstrate worsening shock despite initial treatment with progressive hemodynamic compromise and evidence of multiorgan dysfunction. Prior to device implantation, the patient was supported with inotropes, vasopressors, and respiratory support. The patient was also receiving Impella RP Flex with SmartAssist (SA) support as part of BiPella support.Device Course & Treatment:On Day 3 of Impella 5.5 SmartAssist support, suboptimal waveforms and reduced flows were reported from the Impella 5.5 with SmartAssist. An echocardiogram was requested to further assess device position and function. Following echoca

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930994 ↗
• InjurySep 29, 2026Failure to Advance

  Clinical Narrative:Product/Patient Demographics/Indication/Baseline Presentation:An Impella 5.5 with SmartAssist was planned for insertion via a right-sided arterial approach in a 28-year-old male patient presenting with acute-on-chronic decompensated cardiomyopathy. Specific artery was not reported. The patient's Society for Cardiovascular Angiography and Interventions (SCAI) shock stage was not reported. The patient's medical history was significant for coronary artery disease (CAD). Height and weight were not reported.Device Course & Treatment:During the implantation, the Impella 5.5 was advanced through to the right innominate artery. Despite multiple attempts over approximately one hour, the device could not be delivered to the intended position. Imaging was utilized during the procedure to assess device advancement and positioning. Due to the inability to successfully deliver the device, the procedure was ultimately aborted. No adverse events were reported.Additional Factors:The treating team reported significant curvature of the patient's anatomy in the region of the graft attachment, which was considered a contributing factor to the inability to advance and deliver the devi

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930909 ↗
• MalfunctionSep 28, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923841 ↗
• DeathSep 28, 2026Malposition of Device

  An Impella 5.5 with SmartAssist device was inserted into the left axillary/subclavian artery in a 65-year-old male patient presenting with acute decompensated cardiomyopathy. Prior to Impella support, the patient was classified as Society for Cardiovascular Angiography & Interventions (SCAI) Stage D shock, indicating deterioration despite escalation of therapy. The patient was supported with an intra-aortic balloon pump (IABP), multiple inotropes, vasopressors, and ventilatory support. The patient's medical history was significant for coronary artery disease (CAD) and cardiac arrest requiring cardiopulmonary resuscitation (CPR).On Day 2 of support, while the patient was in the intensive care unit (ICU), the patient developed persistent ventricular tachycardia (VT), which was reported by the clinical team to be related to the Impella 5.5. No additional information regarding device position, troubleshooting measures, or corrective interventions was reported. Subsequently, the medical team elected to withdraw care and the patient expired.Throughout support, the Impella 5.5 functioned at performance level P-8 with reported flows of approximately 5.1 L/min utilizing a D5W Heparin purge

  Patient problems: Tachycardia

  MAUDE report 50923553 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Tachycardia

  MAUDE report 50921393 ↗
• MalfunctionSep 28, 2026Device Sensing Problem

  RN called in with Preventing Retrograde Flow notification at P5. RN weaned the pt to P4 and below are the following Impella numbers:P4Flow 3.2PS 318/150LV 261/69MC 299/206Aline-115/72.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916987 ↗
• InjurySep 28, 2026Device Sensing Problem

  Additional information received stating that the patient is able to bear more weight on her left leg and ambulate with assistance.

  Patient problems: Stroke/CVA

  MAUDE report 50916115 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Product/Patient Demographics/Indication/Baseline Presentation:Impella 5.5 with SmartAssist was inserted via the right subclavian/axillary artery in a 65-year-old male patient (185 cm, 89 kg) for post-cardiotomy cardiogenic shock. The patient's comorbidities were not fully reported. Prior to initiation of Impella support, 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 life-saving therapies, leading to progressive end-organ failure. The patient was receiving unspecified inotropic and vasopressor support. Systemic anticoagulation was maintained with bivalirudin, and the Impella purge solution contained 5% dextrose in water with sodium bicarbonate.Device Course & Treatment:Four days after initiation of Impella support, the patient was cannulated for extracorporeal membrane oxygenation (ECMO) to provide additional mechanical circulatory support. ECMO served as the primary hemodynamic support modality, while the Impella 5.5 provided left ventricular unloading. Following initiation of ECMO support, laboratory findings reportedl

  Patient problems: Hemolysis; Renal Failure; Thromboembolism

  MAUDE report 50914696 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  Impella 5.5 SmartAssist (SA) was inserted via right axillary artery surgical access in a 65-year-old male patient presenting with acute myocardial infarction and cardiogenic shock. The patient's comorbidities included coronary artery disease, diabetes mellitus, renal insufficiency, and dialysis dependence. The patient's clinical condition prior to support initiation was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E, indicating profound cardiogenic shock with hypoperfusion and end-organ dysfunction despite extensive therapeutic interventions. Prior to Impella 5.5 support, the patient had received 45 days of prior Impella support and extracorporeal membrane oxygenation (ECMO). Additional therapies included inotropes, vasopressors, and respiratory support. The patient was being bridged to heart transplantation while receiving multiple forms of mechanical circulatory support.After 88 days of Impella 5.5 SmartAssist support, the device was explanted. The support duration exceeded the device indication for use. Following explant, the patient remained hospitalized. Five days post explant the patient developed neurological changes and experienced a cardiac a

  Patient problems: Cardiac Arrest; Stroke/CVA; Thromboembolism

  MAUDE report 50914359 ↗

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-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-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-2457-2026 · May 18, 2026 · Open, Classified
  Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
• 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-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-2319-2024 · May 31, 2024 · Open, Classified
  Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
• 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-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-0440-2024 · Oct 10, 2023 · Terminated
  Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

…and 5 more.