Impella CP with SmartAssist 1000413Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813502013566), received between Feb 9, 2026 and May 7, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 reports).

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

22 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. May 22, 2026Class IOpen, Classified

   Potential for thrombus formation during prolonged use of the introducer.

   Z-2601-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryMay 7, 2026Inaccurate Flow Rate

  AN IMPELLA CP10 WAS INSERTED THROUGH A 14FR LOW PROFILE SHEATH VIA THE RIGHT FEMORAL ARTERY IN A 65-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), WITH A HISTORY OF PRIOR CORONARY ARTERY BYPASS GRAFTING. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. THE PATIENT WAS ON PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) AND CP10 SUPPORT. BILATERAL DISTAL PERFUSION CATHETERS (DPC) WERE PLACED AT THE TIME OF DEVICE INSERTION. DURING ROUNDS, THE PATIENT WAS NOTED TO HAVE BILATERAL LOWER EXTREMITY ECCHYMOSIS AND ABSENT DISTAL PULSES. BILATERAL ARTERIAL ULTRASOUNDS SHOWED ALMOST ZERO FLOW FOR BOTH LOWER EXTREMITIES, DESPITE BILATERAL DPC. PERIPHERAL VA ECMO WAS A CONTRIBUTING FACTOR. THE PATIENT WAS TAKEN TO THE CARDIOVASCULAR OPERATING ROOM (CVOR) FOR ESCALATION TO IMPELLA 5.5 AND REVISION OF VA ECMO TO PROTEK DUO. DURING PREPARATION, THE AUTOMATED IMPELLA CONTROLLER (AIC) SHOWED SIGNS OF POTENTIAL PUMP SATURATION. PRIOR TO REMOVAL OF CP10, THE LEFT PLACEMENT SHEATH (LPS) WAS ASPIRATED, SHOWING NO SIGN OF THROMBUS. HOWEVER, THROMBUS WAS NOTED IN THE HEMOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112103 ↗
• MalfunctionApr 7, 2026Difficult to Open or Close

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 57-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE D. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE CARE TEAM REPORTED THAT THE BLUE BUTTON ON THE STERILE SLEEVE DID NOT LOCK THE IMPELLA CATHETER APPROPRIATELY AFTER THE YELLOW PIN WAS REMOVED. THROMBUS WAS NOTED AT THE HUB OF THE LOW-PROFILE SHEATH, AND ANGIOGRAPHIC RUNOFF WAS NOT COMPLETED BECAUSE OF CLOT PRESENCE. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED THROMBOSIS MAY BE INFLUENCED BY FACTORS SUCH AS UNDERLYING AMI/CGS PHYSIOLOGY, HEMODYNAMIC INSTABILITY, ANTICOAGULATION STATUS, AND STASIS OR CLOT FORMATION WITHIN THE SHEATH. THE PRODUCT DAMAGE HAD NO IMPACT ON THE PATIENT¿S HEMODYNAMICS. ADDITIONAL INFORMATION WAS RECEIVED. THE STABILITY OF THE CATHETER ANCHOR SEEMED A BIT LOOSE. DRESSINGS WERE ON WHEN THE PATIENT WAS MOVED TO THE BED. THE PATIENT NEEDED TO BE INTUBATED. THERE WAS A FIFTY PERCENT DROP IN FLOW. THE PUMP WAS SHALLOW AND WAS REPOSITIONED. IT COULD BE MOVED WITHOUT HOLDING DOWN THE BUTTON. THE USER BELIEVES THE LOCK "ISN'T AS GOOD" AND IS INTEREST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801425 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A 77-YEAR-OLD MALE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES ARE UNKNOWN. CLINICAL ASSESSMENT PRIOR TO INITIATION OF MECHANICAL CIRCULATORY SUPPORT IDENTIFIED THE PATIENT AS SCAI SHOCK STAGE C. TO PROVIDE HEMODYNAMIC SUPPORT, AN IMPELLA CP C10 DEVICE WAS IMPLANTED VIA THE RIGHT FEMORAL ARTERY USING A 14 FRENCH LOW PROFILE SHEATH. THERE WERE NO KNOWN COMPLICATIONS DURING ACCESS OR INSERTION. POST PROCEDURE, GROIN OOZING AT THE ACCESS SITE WAS OBSERVED; THIS WAS EFFECTIVELY MANAGED USING MANUAL PRESSURE. THERE WAS ADDITIONAL BLEEDING BEYOND THE ACCESS SITE OOZE NOTED. THE BLEEDING WAS AT THE PATIENT'S GUMS AND AT THE FOLEY, AND SO PLASMA BLOOD PRODUCT WAS INFUSED TO THE PATIENT. WHILE ON IMPELLA SUPPORT, THE PURGE SOLUTION CONSISTED OF D5W WITH BICARBONATE. DEVICE PERFORMANCE REMAINED WITHIN THE EXPECTED RANGE FOR THE SELECTED SUPPORT LEVEL, WITH REPORTED FLOW AT 1.9 L/MIN ON P-4. THE PATIENT TOLERATED SUPPORT APPROPRIATELY AND WAS SUCCESSFULLY WEANED OVER THE COURSE OF TWO DAYS, AFTER WHICH THE IMPELLA CP C10 AND ASSOCIATED LOW-PROFILE SHEATH WERE REMOVED. FOLLOWING EXPLANT, THE TREATING PHYSICIAN NOTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24579486 ↗
• DeathMar 7, 2026Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IMPELLA CP 10 WAS INSERTED THROUGH THE 14FR LOW PROFILE SHEATH VIA THE FEMORAL ARTERY IN A 70 YEAR OLD MALE WHO PRESENTED IN AMI/CGS WITHOUT INCIDENT. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. POST PROCEDURE, IN PREPARATION TO THE ICU, THE PHYSICIAN HAD DIFFICULTY WITH BLUE LOCKING MECHANISM DUE TO IT BEING TURNED TO THE LOCKED POSITION PRIOR TO ATTEMPTING TO LOCK TO SHEATH. ONCE THIS WAS REALIZED, CORRECT LOCKING POSITION TO THE SHEATH WAS OBTAINED AND THE SITE WAS DRESSED IN STANDARD FASHION. WHILE ON SUPPORT THE DEVICE FUNCTIONED AS EXPECTED FOR THE SET P LEVEL, P-9 / 3.5L/MIN. HOWEVER, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA STORM AND EXPIRED WHILE ON SUPPORT. THE ARRYTHMIA AND PATIENT OUTCOME IS MOST LIKELY DUE TO THE PATIENTS CLINICAL PRESENTATION OF STAGE D CARDIOGENIC SHOCK.

  Patient problems: Tachycardia

  MAUDE report 24539892 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DURING PUMP REMOVAL, SHEATH SIDEARM ASPIRATED, GOT STUCK AT 2/3CC CHANGED PORT, PULLED 20CC, NO CLOT (BUT CLOT CAUGHT BETWEEN SIDEARM AND CONNECTOR). REMOVED THROUGH SHEATH. THE PHYSICIAN DECIDED NOT TO DO PLANNED ANGIO DUE TO THROMBUS CONCERN. AT SHEATH REMOVAL, SHEATH SIDEARM ASPIRATED AND CLOT FOUND. ASPIRATED AGAIN, SMALLER CLOT FOUND, BUT THIRD ASPIRATION WAS CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 24300305 ↗

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-0980-2024 · Dec 27, 2023 · Open, Classified
  Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5
• 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.

…and 7 more.