Introducer Kit for Impella® 0052-3014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813502010237), received between Nov 10, 2017 and Nov 30, 2018 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2018Leak/Splash; Leak/Splash

  PATIENT WAS ADMITTED FOR A HIGH RISK ANGIOPLASTY OF THE CORONARY ARTERIES. ACCESS AT THE LEFT FEMORAL ARTERY FOR PLACEMENT OF THE IMPELLA CP, HUB LEAK OBSERVED WITH BLOOD LOST. 14FR INTRODUCER REMOVED AND REPLACED BY 16FR COOK. NO BLOOD PRODUCTS GIVEN TO CONTROL BLOOD LOSS. PATIENT IS STABLE AND NO EXTENDED HOSPITALIZATION REPORTED. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8121295 ↗
• MalfunctionJun 18, 2018Crack; Crack

  IT WAS REPORTED THAT DURING A HRPCI (HIGH RISK PERCUTANEOUS CORONARY INTERVENTION) PROCEDURE, ON (B)(6) 2018, AN INTRODUCER CRACKED AFTER INSERTION. THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE AS FOLLOWS: UPON REMOVAL OF THE DILATOR, BLEEDING WAS NOTED FROM AROUND THE SHEATH. AFTER REMOVING THE SHEATH, A CRACK IN THE 14F 13CM INTRODUCER WAS FOUND. AMOUNT OF BLOOD LOSS IS UNKNOWN AT THIS TIME. PATIENT IS REPORTED TO BE STABLE, NO EXTENDED HOSPITALIZATION WAS REQUIRED. THE DEVICES ARE NOT AVAILABLE TO RETURN AS THEY WERE DISCARDED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611196 ↗
• DeathNov 10, 2017Kinked; Split; Deformation Due to Compressive Stress; Kinked; Split; Deformation Due to Compressive Stress

  ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE FOLLOWING: THE IMPELLA WAS ATTEMPTED TO BE PLACED ON (B)(6), AT 10:15 AM. THE ATTEMPT WAS ABORTED, AND PATIENT EXPIRED ON (B)(6) AT 10:51 AM. SALVAGE SITUATION AND ACCESS ATTEMPTS WERE CEASED. PHYSICIAN'S PLAN WAS TO PLACE IMPELLA CP FOR SUPPORT. IN THE ICU THE PATIENT CODED DURING PREP TO CCL (CARDIAC CARE LAB). CPR STARTED AND CONTINUED THRU OUT ATTEMPTED IMPELLA INSERTION. IN CCL SHEATH WAS BEING PLACED INTO RIGHT FEMORAL. IMPELLA WAS OPENED AND PREPPED READY FOR IMPLANT. VISUALIZATION WAS POOR DURING PLACEMENT OF PIGTAIL AND WOULD NOT ADVANCE TO THE LEFT VENTRICLE. WHEN FLUORO VISUALIZATION WAS MADE IT SHOWED THE WIRE LOOPED WITHIN ARTERY. DECISION WAS MADE TO TRY THE LEFT FEMORAL ARTERY FOR ACCESS, BUT COULD NOT GAIN ACCESS TO THE ARTERY. WITH NO ROSC (RETURN OF SPONTANEOUS CIRCULATION) PROCEDURE WAS ABORTED. THE INITIAL INSERTION WAS THE SAME SIDE AS THE A-LINE THAT WAS PLACE POST IABP. PHYSICIAN SAID INSERTION WAS POTENTIALLY LOWER THAN PREFERRED. ANGULATION OF STICK IS UNKNOWN. PATIENT WAS OBESE WITH LARGE PANIS (AN ABNORMAL LAYER OF FIBROVASCULAR TISSUE OR GRANULATION TISSUE). THE LFA WAS NOT ACCESSED DUE TO ACTIVE CPR

  Patient problems: Death

  MAUDE report 7022665 ↗

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-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-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-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