Impella 1000434Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813502012996), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K222113); 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 16, 2026.

Recalls naming this device

1. May 22, 2026Open, Classified

   Potential for thrombus formation during prolonged use of the introducer.

   Z-2599-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryMar 30, 2026Difficult to Flush; Difficult to Remove

  IMPELLA CP 10 WAS INSERTED THROUGH THE 14FR LOW PROFILE SHEATH VIA THE FEMORAL ARTERY IN A 65 YEAR OLD FEMALE 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 C. POST PROCEDURE IN THE ICU THE SHEATH SIDEARM WAS HOOKED UP TO A PRESSURE BAG WITH NS AND HEPARIN. THE FOLLOWING DAY AT 9:30AM IT WAS NOTED THAT THERE WAS MISCOMMUNICATION AND THE SIDEARM FLUSH WAS DISCONTINUED. IT WAS RECONNECTED AT 10:30AM THAT SAME DAY. WHILE ON SUPPORT THE DEVICE PERFORMED AS EXPECTED P-9 3.5L/MIN WITH NO NOTED ALARMS OR CONCERNS. UPON PLANNED REMOVAL, AFTER THE SHEATH WAS REMOVED, DURING STANDARD ASPIRATION OF THE SHEATH IT WAS NOTED TO BE "STUCK". THE SHEATH WAS PULLED BACK SLIGHTLY WITH SOME SUCCESS, HOWEVER, THERE WAS STILL NOTED DIFFICULTY DURING ASPIRATION. THE SYRINGE WAS THEN DISCONNECTED AND THE STOPCOCK WAS LEFT OPEN, WHICH SHOWED ADEQUATE FLOW. AFTER UTILIZING NEW SYRINGE AND ASPIRATION, CLOT WAS NOTED. THEY THEN UTILIZED A SLIP TIP SYRINGE TO ASPIRATE THROUGH THE VALVE AND CLOT WAS NOTED TO HAVE BEEN ASPIRATED FROM THERE AS WELL. SECOND ASPIRATION WAS FOUND TO BE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24734922 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222113. One submission often covers many models, so check the product and lot details in each record.

• Z-2128-2023 · May 26, 2023 · Open, Classified
  Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457