Impella 0052-3018Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04260113630327), received between Jan 14, 2026 and Mar 30, 2026 — classified as 4 injuries, 2 malfunctions.

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

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMar 30, 2026Malposition of Device; 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 24724023 ↗
• MalfunctionMar 18, 2026Difficult to Insert

  THIS IMPELLA GUIDEWIRE DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA RP FLEX PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629598 ↗
• InjuryMar 2, 2026Failure to Advance

  AN IMPELLA CP WAS INSERTED IN A 65 YEAR OLD MALE ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT'S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE E. THE PATIENT WAS BRIDGED TO 5.5 FOR AORTIC VALVULOPLASTY. ON DAY 7 OF 5.5 SUPPORT, AN ATTEMPT WAS MADE TO ESCALATE THE PATIENT TO BIPELLA SUPPORT. AN IMPELLA RP FLEX WAS ATTEMPTED VIA RIGHT FEMORAL VEIN. THE DEVICE WAS UNABLE TO PASS DUE TO THE PATIENT'S VASCULATURE, WHICH APPEARED TO CAUSE THE WIRE TO PROLAPSE AND POSSIBLE DISSECTION OF THE VEIN. IT WAS REPORTED A TEMPORARY PACER WAS ALSO PREVIOUSLY PLACED IN THAT VESSEL. THE RP FLEX IMPLANT WAS ABORTED. VASCULAR INJURY IS A KNOWN POTENTIAL ADVERSE EVENT OF THE IMPELLA RP FLEX PER THE INSTRUCTIONS FOR USE. THE COMPLAINANT HAS ALSO REPORTED THAT THE DEVICE HAS SINCE BEEN DISCARDED AND THAT THE PATIENT'S OUTCOME WAS GOOD. THE DEVICES WERE EXPLANTED MONDAY 2/22 AND THE PATIENT WAS DOWNGRADED OUT OF THE ICU.

  Patient problems: Vascular Dissection

  MAUDE report 24483352 ↗
• MalfunctionFeb 23, 2026Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION INDICATES THAT THE 027 WIRE WAS NOT USED AND WAS SHIPPED BACK IN A RETURN KIT. THE ABIOMED 018 WIRE WAS USED INSTEAD FOR SUCCESSFUL DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424588 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CLINICIAN NARRATIVE: AN IMPELLA RP FLEX WITH SMARTASSIST WAS PLACED VIA RIGHT FEMORAL VENOUS ACCESS IN A 73-YEAR-OLD FEMALE WITH A MEDICAL HISTORY SIGNIFICANT FOR CORONARY ARTERY DISEASE, PRIOR MYOCARDIAL INFARCTION WITH STENTS, SEVERE MITRAL REGURGITATION STATUS POST MITRAL VALVE REPAIR, AND END-STAGE RENAL DISEASE ON HEMODIALYSIS. THE PATIENT PRESENTED IN CARDIOGENIC SHOCK SECONDARY TO ACUTE MYOCARDIAL INFARCTION AND WAS RECEIVING INOTROPES, VASOPRESSORS, AND MECHANICAL VENTILATORY SUPPORT. SHE WAS CLASSIFIED AS SCAI STAGE E AT THE TIME OF INTERVENTION. DURING PROCEDURAL PREPARATION, THE RIGHT INTERNAL JUGULAR VEIN WAS ACCESSED WITH THE INTENT TO PLACE THE INTRODUCER FOR IMPELLA RP FLEX SUPPORT. THE EXISTING HEMODIALYSIS CATHETER WAS REMOVED OVER A WIRE, AND SERIAL DILATION WAS PERFORMED USING AN 8 FR DILATOR FOLLOWED BY A 20 FR DILATOR. DURING ATTEMPTED ADVANCEMENT OF A 23 FR PEEL-AWAY INTRODUCER SHEATH, THE GUIDEWIRE WAS NOTED TO BE INSUFFICIENTLY POSITIONED WITHIN THE CENTRAL VENOUS SYSTEM. SUBSEQUENT ADVANCEMENT RESULTED IN LOSS OF WIRE POSITION, AND IMAGING REVEALED THE WIRE HAD ENTERED THE PLEURAL SPACE WITH INFERIOR TRACKING NEAR THE DIAPHRAGM. THE WIRE WAS REMOVED, AND TH

  Patient problems: Great Vessel Perforation

  MAUDE report 24266884 ↗
• InjuryJan 14, 2026Difficult to Insert; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA RP FLEX EXPERIENCED LOSS OF FLOWS. THE PUMP WAS EXPLANTED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24067204 ↗