Impella 0550-0008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,005 adverse event reports that list this exact device (DI 00813502011531), received between Sep 30, 2021 and Mar 11, 2026 — classified as 87 deaths, 410 injuries, 508 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (160 reports).

4 FDA recall records name this device's identifier, 4 still open.

21 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 5, 2024Class IIOpen, 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-2963-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 27, 2023Class IOpen, 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 ↗

3. Dec 27, 2023Class IIOpen, 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 ↗

4. Jun 14, 2023Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,005 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  A 69-YEAR-OLD FEMALE PATIENT WAS ADMITTED WITH ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK. SHE WAS IMPLANTED WITH AN IMPELLA 5.5 FOR CARDIAC SUPPORT. THE PATIENT DEVELOPED A HEMATOMA AT THE GROIN ACCESS SITE AND HAD TO HAVE IT SURGICALLY EVACUATED. ON (B)(6) 2025, THE IMPELLA WAS REMOVED.

  Patient problems: Hematoma

  MAUDE report 24569768 ↗
• MalfunctionDec 9, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT A PATIENT ON IMPELLA SUPPORT WAS EXPERIENCING PLACEMENT SIGNALING ISSUES DUE TO ALLEGEDLY A DAMAGED SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758691 ↗
• MalfunctionDec 8, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT A PATIENT ON IMPELLA SUPPORT EXPERIENCED SOME INTERMITTENT FALSELY TRIGGERED POSITION IN AORTA ALARM. THE RN REVIEWED THE PATIENT ON BEDSIDE AND FOUND NO IMPELLA ISSUES. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23736880 ↗
• MalfunctionDec 8, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT PLACEMENT SIGNAL MONITORING WAS DISABLED DUE TO ONGOING FALSE POSITION ALARMS. SUPPORT WAS MAINTAINED THROUGHOUT THE INCIDENT. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23736709 ↗
• MalfunctionNov 12, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT THEIR AUTOMATED IMPELLA CONTROLLER (AIC) FAILED TO DISPLAY A PLACEMENT SIGNAL AND BEGAN TO ALARM WITH A PLACEMENT SIGNAL NOT RELIABLE ALARM. THE AIC WAS SWAPPED, HOWEVER THE PLACEMENT SIGNAL STILL FAILED TO REPOPULATE. PATIENT SUPPORT CONTINUED WITH NO KNOWN PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532413 ↗
• MalfunctionOct 21, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT THE PUMP EXPERIENCED AN OPTICAL SENSOR FAILURE AFTER THE DEVICE WAS REPOSITIONED DURING SUPPORT. BOTH THE PLACEMENT SIGNAL AND LV SIGNAL STOPPED WORKING AS A RESULT OF THE FAILURE. PATIENT SUPPORT CONTINUED WITH THE INSTALLED DEVICE AS THE MOTOR CURRENT, FLOWS, AND PURGE PRESSURE REMAINED WITHIN ACCEPTABLE LIMITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348108 ↗
• DeathSep 12, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT A PATIENT ON IMPELLA 5.5 SUPPORT ENCOUNTERED A PLACEMENT SIGNALING ALARM. THE ALARM PERSISTED DESPITE CHANGING THE AUTOMATED IMPELLA CONTROLLER. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT, HOWEVER, THE PATIENT EVENTUALLY EXPIRED DURING SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043188 ↗
• DeathSep 12, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED A PLACEMENT SIGNAL UNRELIABLE AND POSITION IN THE AORTA ALARMS OCCURRING ON AND OFF OVER THE WEEKEND FOR A PATIENT ON IMPELLA 5.5 SUPPORT. ECHOCARDIOGRAPHY SHOWED GOOD POSITION, AND STAFF ELECTED TO DISABLE AUDIO. THE DEVICE WAS NOT REPLACED OR REMOVED, AND NO CONSOLE WAS SWITCHED. THE PATIENT EVENTUALLY EXPIRED ON SUPPORT UNRELATED, TO THE ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042938 ↗
• MalfunctionSep 9, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. DURING SUPPORT, THE PLACEMENT SIGNAL WAS LOST. THE ALARM WAS DISABLED, AND PUMP SUPPORT CONTINUED WITHOUT INTERRUPTION. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006876 ↗
• MalfunctionSep 9, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. DURING SUPPORT, THE PLACEMENT SIGNAL BECAME UNRELIABLE. THE ALARM WAS DISABLED, AND PUMP SUPPORT CONTINUED WITHOUT INTERRUPTION. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006787 ↗
• MalfunctionAug 6, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. DURING SUPPORT, THE PUMP TRIGGERED PLACEMENT SIGNAL ISSUES. THE PUMP WAS NOT REMOVED. SUPPORT WAS CONTINUED, AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731865 ↗
• MalfunctionAug 6, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. DURING SUPPORT, THE PUMP TRIGGERED MULTIPLE 'IMPELLA IN AORTA' ALARMS DESPITE CONFIRMED PROPER POSITIONING. SUPPORT WAS CONTINUED, AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731835 ↗
• MalfunctionAug 6, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. THE PUMP TRIGGERED A 'PLACEMENT SIGNAL LOST' ALARM AFTER MORE THAN 70 DAYS OF RUNTIME. PUMP POSITION WAS CONFIRMED VIA ECHOCARDIOGRAPHY. SUPPORT WAS CONTINUED, AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731707 ↗
• MalfunctionAug 6, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. THE PUMP TRIGGERED A 'PLACEMENT SIGNAL NOT RELIABLE' ALARM BOTH DURING SETUP AND SUPPORT. SUPPORT WAS CONTINUED, AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731248 ↗
• MalfunctionAug 6, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED FOR CIRCULATORY SUPPORT. DURING USE, THE PUMP TRIGGERED A FALSE 'IMPELLA IN AORTA' ALARM. PROPER PUMP POSITIONING WAS CONFIRMED VIA ECHOCARDIOGRAPHY. NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730723 ↗
• DeathMar 31, 2025Restricted Flow rate; Malposition of Device; Restricted Flow rate; Malposition of Device

  THE COMPLAINANT REPORTED A PATIENT IN NON-ST ELEVATION MYOCARDIAL INFARCTION WITH HYPOTENSION, ACUTE SEVERE MITRAL REGURGITATION, AND LOW EJECTION FRACTION WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT TO STABILIZE AND UNLOAD THE PATIENT'S LEFT HEART. DURING DELIVERY OF THE IMPELLA INTO THE LEFT VENTRICLE, THE IMPELLA 5.5 WAS PLACED DIRECTLY INFO THE PAPILLARY WALL AND WAS UNABLE TO BE MOVED. THE MEDICAL TEAM WAS ADVISED TO PULL THE GUIDEWIRE, AND THEN TURN THE IMPELLA AS THERE WAS SUSPICION THE GUIDEWIRE WAS IN THE CHORDAE. THE PATIENT THEN WENT INTO BRADYCARDIA AND LOST BLOOD PRESSURES. THE IMPELLA 5.5 WAS SUCCESSFULLY TURNED TOWARDS THE APEX AFTER REMOVAL OF THE GUIDEWIRE AND SUPPORT WAS THEN INITIATED. IT WAS NOTED BY THE PHYSICIAN THEY BELIEVE THAT THE PATIENT'S PRESSURES DROPPED DUE TO THE RIGHT CORONARY ARTERY BEING COMPLETELY BLOCKED AND HAVING NO PERFUSION. DURING SUPPORT, THERE WERE SUCTION ALARMS. THE POWER LEVEL OF THE IMPELLA 5.5 WAS DROPPED FROM P9 TO P8 AND THE PATIENT WAS GIVEN FLUID VOLUME TO RESOLVE THE ALARMS. THE PATIENT REMAINED ON SUPPORT FOR 5 DAYS, AND IT WAS DETERMINED THE PATIENT WAS UNLIKELY TO SURVIVE ANY FURTHER REVASCULARI

  Patient problems: Bradycardia

  MAUDE report 21732384 ↗
• DeathMar 31, 2025Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WAS THEN ESCALATED FROM THE IMPELLA CP TO AN IMPELLA 5.5 FOR INCREASED CIRCULATORY SUPPORT AFTER 4 DAYS OF SUPPORT ON THE IMPELLA CP. WHEN THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) TO REPLACE THE IMPELLA CP WITH IMPELLA 5.5 THE DECISION WAS MADE FOR THE PATIENT TO HAVE CORONARY ARTERY BYPASS (CABG). THE PATIENT WAS PLACED ON BYPASS, AND THE IMPELLA WAS PLACE DIRECTLY THROUGH THE AORTA AFTER AN AORTIC VALVE REPLACEMENT WAS PERFORMED. CABG WAS PERFORMED SUCCESSFULLY AND WITHOUT COMPLICATIONS. THE IMPELLA 5.5 PLACEMENT WAS CONFIRMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), SUPPORT WAS INITIATED AND THE PATIENT WAS WEANED OFF BYPASS. TEE OF THE RIGHT VENTRICLE REVEALED WORSENING RIGHT HEART FUNCTION. THE PATIENT WAS GIVEN AN INCREASED INOTROPE SUPPORT AND TRANSPORTED BACK TO THE ICU. THE FOLLOWING DAY, ON (B)(6) 2022, THE PATIENT WAS TAKEN BACK TO THE OR FOR VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION CANNULATION (VA ECMO) DUE TO THE FAILING RIGHT VENTRICLE AND ASSOCIATED DECOMPENSATION. DURING THIS

  Patient problems: Insufficient Information

  MAUDE report 21732344 ↗
• MalfunctionMar 17, 2025Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS UNABLE TO PASS THROUGH THE PATIENT'S VASCULATURE DURING ATTEMPTED DELIVERY. AS A RESULT OF THE RESISTANCE CAUSED BY THE PATIENT'S ANATOMY, THE DECISION WAS MADE TO ABORT THE IMPLANT. AN INTRA-AORTIC BALLOON PUMP WAS SUBSEQUENTLY IMPLANTED FOR PATIENT SUPPORT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21623635 ↗
• MalfunctionMar 17, 2025Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 PUMP WAS UNABLE TO PASS THROUGH THE PATIENT'S TORTUOUS VASCULATURE DURING ATTEMPTED DELIVERY. AS A RESULT OF THE NOTED RESISTANCE CAUSED BY THE PATIENT'S ANATOMY, THE DECISION WAS MADE TO ABORT THE IMPLANT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620452 ↗
• MalfunctionMar 17, 2025Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT THE MEDICAL TEAM WAS HAVING DELIVERY ISSUES WITH THE IMPELLA 5.5 PUMP BECAUSE THE AXILLARY ARTERY WAS TOO SMALL SO THE PUMP WAS ABORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619988 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA THE IMPACT EU STUDY A PATIENT EXPERIENCED A MEDIASTINAL HEMORRHAGE WITH A DEFINITE RELATIONSHIP TO IMPELLA DEVICE. THE ADVERSE EVENT NARRATIVE EXPLAINED THE PATIENT WAS GOING TO BE DISCHARGED THE DAY OF THE EVENT (WHICH WAS FOUR DAYS AFTER EXPLANT OF THE IMPELLA 5.5 DEVICE; THE PATIENT RECOVERED TO NATIVE HEART FUNCTION). THE PATIENT WAS UNRESPONSIVE AFTER THE SECOND WALK TO THE ROOM ON THE UNIT. THE PATIENT'S PULSE DROPPED, AND CODE BLUE WAS ACTIVATED. CARDIOPULMONARY WAS ADMINISTERED AND RETURN OF SPONTANEOUS CIRCULATION ACHIEVED. THERE WAS A SIGNIFICANT GROWING LEFT PLEURAL EFFUSION. LEFT CHEST TUBE WAS PLACED WITH RETURN OF 1500ML OF BLOOD. THE PATIENT RECEIVED 4 UNITS OF PACKED RED BLOOD CELLS, 1 FRESH FROZEN PLASMA AND 1 PLATELET. ARTERIAL BLOOD GAS REVEALED ACIDOSIS, 4 AMPS. BICARBONATE WAS GIVEN. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR MEDIASTINAL WASHOUT. SMALL BLEEDING FROM THE SIDE OF THE RIGHT CORONARY BUTTON WAS FOUND AND STITCH WAS PLACED. THE PATIENT WAS NOTED TO HAVE SURVIVED THE EVENT.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Intraoperative Cardiac Injury; Pleural Effusion; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 21420301 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABIOMED JAPAN FORWARDED 7 PUBLICATIONS. ONE FROM TEAM IN CT/(B)(6) HOSPITAL WHICH WAS ENTITLED: "ONE PUMP FOR TWO HEARTS: USING AN IMPELLA 5.5 MICRO-AXIAL PUMP IN PERIPARTUM CARDIOGENIC SHOCK" WHICH DETAILS A CP SUPPORT IN AN EXPECTANT MOTHER WHO HAD AN ACCESS SITE OOZE. UNTIL THE DAY BEFORE DELIVERY, SHE WAS ANTICOAGULATED WITH HEPARIN, ALONG WITH A HEPARIN-BASED PURGE FLUID. A DAY BEFORE DELIVERY, SHE DEVELOPED EPISTAXIS AND OOZING FROM THE IMPELLA PLACEMENT SITE. ANTICOAGULATION WAS TEMPORARILY STOPPED, AND THE HEPARIN-BASED PURGE FLUID WAS SUBSTITUTED WITH 5% DEXTROSE BUT OOZING CONTINUED. ULTIMATELY A DECISION TO PROCEED WITH DELIVERY WAS MADE DUE TO PERSISTENT OOZING DESPITE HOLDING HEPARIN AND SEVERE FETAL GROWTH RESTRICTION. THE PROCEDURE WAS SUCCESSFUL WITH ANOTHER DEVICE AND THE PROCEDURAL OUTCOME WAS THE PATIENT SURVIVED SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21021688 ↗
• DeathNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT HAD BEEN ESCALATED FROM AN IMPELLA CP TO THE IMPELLA 5.5 AS HEMODYNAMIC SUPPORT NEED HAD INCREASED. AFTER BEING IMPLANTED WITH THE IMPELLA 5.5 IT WAS REPORTED THAT THE PATIENT WAS BLEEDING FROM MULTIPLE SITES AND WAS TRANSFUSED WITH BLOOD PRODUCTS AS A RESULT OF THE BLEEDING. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH HEPARIN INDUCED THROMBOCYTOPENIA. IT WAS REPORTED THE PATIENT'S PLATELET COUNT WAS 19,000 CELLS PER MICROLITER. THE PATENT WAS TRANSFUSED WITH PLATELETS AND BLOOD PRODUCTS. ADDITIONALLY, THE PATIENT HAD THREE EPISODES OF VENTRICULAR FIBRILLATION AND REQUIRED DEFIBRILLATION TO RESOLVE EACH EPISODE. A FAMILY MEETING WAS CALLED TO DISCUSS WITHDRAWING CARE. IT IS UNKNOWN IF CARE WAS WITHDRAWN, HOWEVER IT IS NOTED THAT THE PATIENT EXPIRED WHILE ON SUPPORT. THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombocytopenia; Ventricular Fibrillation

  MAUDE report 20814125 ↗
• DeathNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT IT WAS NOTED THAT THERE WAS BLEEDING AT THE ACCESS SITE THAT WAS BEING MANAGED WITH WOUND VAC AND TRANSFUSIONS. ADDITIONAL INFORMATION WAS PROVIDED THAT NOTED THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20769001 ↗
• DeathNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH CARDIOGENIC SHOCK FROM AN ACUTE MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AND EXPERIENCED A HEMORRHAGIC STROKE WITH A DEMISED OUTCOME. THE PATIENT WAS ESCALATED FROM A IMPELLA CP TO THE IMPELLA 5.5 FOR HEMODYNAMIC SUPPORT. SIX DAYS INTO SUPPORT, THE PATIENT REMAINED INTUBATED AND SEDATED BUT FOLLOWED COMMANDS, AND THE PATIENT WAS NOTED TO HAVE EXPERIENCED A SUBARACHNOID BLEED. HEPARIN WAS PUT BACK INTO PURGE AFTER REPEAT HEAD COMPUTED TOMOGRAPHY SCAN. OF NOTE, UNRELATED, IT WAS DOCUMENTED THAT THE PATIENT WAS BEING TREATED FOR A FUNGAL INFECTION IN LUNGS. CARE WAS EVENTUALLY WITHDRAWN FOUR DAYS LATER, AND THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS NOTED.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 20768908 ↗

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-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-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.

…and 6 more.