Impella 1000441Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813502012910), received between Jan 20, 2026 and Aug 3, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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

12 other recalls cover devices cleared under the same FDA submission (K201116); 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-2684-2026 · Root cause: Under Investigation by firm · 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.

• InjuryAug 3, 2026Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  Clinical Narrative:Impella RP flex was inserted percutaneously via right internal jugular vein access site in an 59-year-old female patient presenting with post-operative cardiothoracic surgery. The patient¿s comorbidities were prior coronary artery bypass graft (CABG) and known coronary artery disease (CAD). The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. The patient was medically supported by inotropes, vasopressors and respiratory support.During vascular access, difficulty was encountered while advancing the 23 Fr peel-away introducer sheath. The physician removed the sheath and observed that the sheath tip was buckled inward/collapsed. A replacement introducer from a second RP kit was obtained and inserted successfully without further issue. Following RP Flex insertion, a ¿Placement Signal Not Reliable¿ alarm was observed on the Automated Impella Controller (AIC) resulting in no Placement Signal or flows displayed. The lack of flow and placement signals being displayed had no noted impact on hemodynamic support provided or the patient. Purge pressure and purge flow remained within app

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115753 ↗
• InjuryApr 3, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE IMPELLA DEVICE WAS EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 24775504 ↗
• InjuryMar 30, 2026Difficult or Delayed Positioning; Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY AND AN IMPELLA RP FLEX WAS INSERTED INTO THE RIGHT FEMORAL VEIN IN A 64-YEAR-OLD MALE PATIENT PRESENTING IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), AND IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, ACCESS WAS OBTAINED TO THE RIGHT JUGULAR VEIN BUT WAS LOST. THE SHEATH AND GUIDEWIRE CAME OUT. THE PHYSICIAN ATTEMPTED TO REGAIN ACCESS BUT WAS UNSUCCESSFUL. ACCESS WAS THEN OBTAINED IN THE RIGHT FEMORAL VEIN, AND THE RP FLEX WAS INSERTED. THIRTY SECONDS LATER, THE PATIENT'S PRESSURES BEGAN TO DROP, AND WHEN VERIFYING POSITION, THE OUTLET CAGE SLIPPED INTO THE RIGHT VENTRICLE. SEVERAL ATTEMPTS WERE MADE TO PUSH THE RP FLEX BACK ACROSS THE PULMONARY ARTERY VALVE, WITHOUT SUCCESS. THE PATIENT CONTINUED TO CODE, AND THE PATIENT EXPIRED. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, W

  Patient problems: Vascular Dissection

  MAUDE report 24725637 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA RP FLEX DEVICE WAS INSERTED VIA THE RIGHT FEMORAL VEIN IN A (B)(6) YEAR-OLD MALE PATIENT. PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E, WITH A HISTORY OF PRIOR CABG, KNOWN CORONARY ARTERY DISEASE, AND RENAL INSUFFICIENCY. DURING PLACEMENT, THE HEMOSTATIC SUTURE BROKE WHILE REMOVING THE 23 FR PEEL-AWAY SHEATH, REQUIRING PLACEMENT OF A NEW SUTURE WHILE CONTROLLING ACTIVE GROIN BLEEDING. A FORWARD-TENSION DRESSING WAS APPLIED, AND ALTHOUGH THE CATHETER WAS NOTED TO BE VERY POSITIONAL, BLEEDING WAS CONTROLLED. HEMOGLOBIN REMAINED NORMAL. PATIENT SURVIVED TO EXPLANT. THE REPORTED MAJOR BLEED REQUIRING SURGICAL INTERVENTION IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24626173 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PHYSICIAN PLACED THE RP FLEX INTRODUCER AND DILATOR INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN (RIJ). UPON REMOVING THE DILATOR, THE HEMOSTATIC VALVE DID NOT SEAL. BLOOD WAS COMING OUT OF THE HEMOSTATIC VALVE. INTRODUCER REMOVED OVER A WIRE AND MANUAL PRESSURE HELD. NEW RP FLEX INTRODUCER AND DILATOR WERE INSERTED INTO THE SITE. NEW DILATOR REMOVED AND HEMOSTATIC VALVE SEALED WITH NO ISSUE. RP FLEX CATHETER ADVANCED THROUGH THE NEW INTRODUCER WITHOUT ISSUE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114840 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201116. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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-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-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-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-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-2683-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump an