Introducer Kit for Impella® 0052-3000 (UDI 00885672009748)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672009748), received between Jan 14, 2020 and Feb 27, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K122084); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2020Break; Break

  A FEMALE PATIENT (AGE UNKNOWN) WAS PRESENTED TO THE PHYSICIAN UNDER RESUSCITATION WITH CARDIOGENIC SHOCK (CGS) SIGNS. PATIENT WENT IN THE INTENSIVE CARE UNIT (ICU) WITH VA-EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) BEING IN CARDIOGENIC SHOCK (CGS). THE DEVICES WERE USED FOR CGS DUE TO ACUTE MYOCARDIAL INFARCTION (AMI). TWO OSCOR (2) 14FR INTRODUCERS SHEATHS FAILED, THE SHEATH'S SPLIT AT THE TIP AND ROLLED UP, AND THEY WERE DISCARDED; THEY ALSO USED A COMPETITOR'S 13F INTRODUCER (TRIAL FOR DILATATION). AFTER SUCCESSFUL IMPLANTATION OF VA-ECMO AN ANGIOLOGIST HAD TO INTERVENE, BECAUSE THERE WERE INNER BLEEDINGS IN THE GROIN. PATIENT IS OBESE, DIFFICULT TO LOCATE ARTERIA UNDER CPR, PUNCTURING WITH NEEDLE. PHYSICIAN REPORTED THE SHEATHS PROBABLY FAILED BECAUSE THEY WERE TOO SHORT AND TOO SOFT/ FRAGILE, AS A LOT OF TISSUE NEEDED TO BE CROSSED, DUE TO OBESE PATIENT. OBVIOUSLY THEY INJURED A SIDE BRANCH FROM ARTERY FEMORALIS DURING ACCESS ATTEMPTS (PUNCTURING THE ARTERIA). IT WAS REPORTED THE REPRESENTATIVE SAW THE GROIN ANGIOLOGY/ FLUOROSCOPY - THERE WAS OBVIOUSLY NO PERIPHERAL ARTERIAL DISEASE (PAD) OR KINKING OF THE ARTERIA FEMORALIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cardiogenic Shock

  MAUDE report 9765348 ↗
• MalfunctionJan 14, 2020Break; Break

  IT WAS REPORTED THE PATIENT WAS PRESENTED TO THE PHYSICIAN WITH HEMODYNAMIC SUPPORT FOR CARDIOGENIC SHOCK (CGS) AND THE CLINIC DECIDED TO IMPLANT IMPELLA CP. BEFORE USING THE ABIOMED 14F INTRODUCER, THEY USED TERUMO RADUFOCUS INTRODUCER II WITH 8F. THE OBTURATOR PART HAD BEEN INTRODUCED WITHOUT PROBLEMS, EVERYTHING RUNS IN NORMAL WAY. AS THEY USED THE 14F INTRODUCER, THEY DILATE WITH 10F / 12F. THEN THEY TOOK THE 14F INTRODUCER PEEL AWAY SYSTEM. BEFORE LAUNCHING IN THE VESSEL, THE TOP OF THE PEEL AWAY SYSTEM SPLIT IN TWO PIECES. SO THEY TOOK A SECOND PEEL AWAY SYSTEM AND EVERYTHING RUNS NORMAL. CUSTOMER REPORTED NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED, HOWEVER THERE WAS A DELAY FOR SEVERAL MINUTES. ON (B)(6), 2020, THE CUSTOMER REPORTED THE THERAPY STOPPED THE FOLLOWING NIGHT AND THE PATIENT EXPIRED ON FRIDAY, (B)(6), 2019. AS REPORTED BY PHYSICIAN THE PATIENT WAS IN POOR CONDITION, CAUSE OF DEATH CPR IN ICU AFTER VERY BAD PROGNOSES IN CATH LAB. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cardiogenic Shock; Death

  MAUDE report 9586194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter