Introducer Kit for Impella® 0052-3001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813502011517), received between Jul 10, 2017 and Jul 10, 2020 — classified as 2 deaths, 3 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT CAME FROM INTENSIVE CARE UNIT (ICU) IN A RATHER CRITICAL STATE. THE 23F SHEATH WAS USED FOR ACUTE MYOCARDIAL INFRACTION (AMI) AND A CARDIOGENIC SHOCK (CGS) PROCEDURE. ISSUE WITH THE 23F SHEATH WAS BLEEDING THROUGH THE VALVE, IT WAS IDENTIFIED WHEN SHEATH WAS INSERTED INTO THE FEMORAL VEIN, PHYSICIAN TRIED TO STOP BLEEDING WITH 0.027" WIRE (DIFFERENT VENDORS PRODUCT), THEN 12F SHEATH, THEN RP PUMP (IN THAT ORDER) UNSUCCESSFULLY. ONLY BRIEF DELAY OF THE PROCEDURE DUE TO BLEEDING, NO IMPACT ON PATIENT CONDITION. PATIENT OUTCOME IS DEATH ((B)(6) 2020), HOWEVER, DEATH IS NOT RELATED TO DEVICE FAILURE. PHYSICIAN REPORTED CAUSE OF PATIENT DEATH AS VENTRICULAR TACHYCARDIA (ATTEMPTS TO ACHIEVE SINUSRHYTHM WERE UNSUCCESSFUL) FOLLOWED BY NO OUTPUT FROM LEFT VENTRICLE (LV). ADDITIONALLY, THE PHYSICIAN SAID THAT THE BLOOD LOSS WAS NOT CONTRIBUTING TO THE DEATH OF THE PATIENT SINCE IT WAS NOT THERAPEUTICALLY RELEVANT.

  Patient problems: Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding; Myocardial Infarction; Tachycardia

  MAUDE report 10259632 ↗
• InjuryMar 2, 2020Break; Break

  IT WAS REPORTED THAT PATIENT WAS SUFFERING FROM CARDIOMYOPATHY AND DURING ACCESS AT THE FEMORAL VEIN FOR PLACEMENT OF AN IMPELLA RP, SHEATH SPILT AND PLACEMENT OF SHEATH WAS UNSUCCESSFUL. THERE WAS DELAY IN PROCEDURE REPORTED AS NO BACK UP SHEATH WAS AVAILABLE. PERFORATION OF VEIN OBSERVED WHICH WAS FIXED WITH VESSEL STENTING. PATIENT OUTCOME IS STABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 9776856 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FACILITY ONLY RETURNED THE IMPELLA PUMP, THE INTRODUCER WAS DISCARDED.

  Patient problems: Blood Loss

  MAUDE report 8248288 ↗
• DeathSep 28, 2018Break; Crack; Deformation Due to Compressive Stress; Break; Crack; Deformation Due to Compressive Stress

  THE PATIENT WAS PRESENTED WITH AMI (ACUTE MYOCARDIAL INFARCTION) WITH SHOCK, IMPELLA POST PCI (PERCUTANEOUS CORONARY INTERVENTION). AFTER SECOND ATTEMPT AT IMPELLA RP INSERTION VIA 23FR SHEATH, DISTAL TIP OF INTRODUCER SHEATH WAS MISSHAPED (WAVY) AND CRACK/BREAK WAS NOTED ON INTRODUCER HUB. WHEN MD WAS ABLE TO REMOVE IMPELLA RP, NEW IMPELLA RP PITCHED AND INSERTED INTO PATIENT. THERE WERE NO REPORTED ISSUES NOTED WITH THE PRODUCT PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT OBESE, NO EXCESSIVE FORCE WAS USED TO DELIVER THIS INTRODUCER. THE REP ALSO REPORTED THAT THERE WAS SIGNIFICANT BLEEDING AT THE REPORTED CRACK/ BREAK; MORE THAN 2 UNITS OF REPLACEMENT BLOOD PRODUCTS WERE GIVEN TO THE PATIENT. THE FAMILY WITHDREW SUPPORT AND THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Myocardial Infarction; Shock

  MAUDE report 7920303 ↗
• DeathJan 19, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ADDITIONAL INFORMATION RECEIVED ON 20JUNE2018 THAT INDICATES THE FAMILY WITHDREW MEDICAL CARE ON (B)(6) 2018 BUT, ALTHOUGH REQUESTED, AN EXACT DATE OF DEATH IS UNKNOWN.

  Patient problems: Blood Loss; Death

  MAUDE report 7205341 ↗
• InjuryJul 10, 2017Backflow; Backflow

  DURING THE IMPLANTATION OF AN ABIOMED IMPELLA PUMP ON (B)(6) 2017, WHICH PROCEDURE KIT CONTAINS AND REQUIRES THE USE OF AN 23F PEEL AWAY INTRODUCER. AFTER THE 23F INTRODUCER WAS INSERTED INTO THE PATIENT BODY, THE DILATOR WAS REMOVED, AND THE HEMOSTATIC VALVE HOUSING STARTED TO LEAK IMMEDIATELY. THE LEAK WAS ESTIMATED TO BE ABOUT 15ML/MINUTE, WHICH RESULTED IN A TOTAL BLOOD LOSS BEFORE, DURING AND AFTER THE PUMP IMPLANT PROCEDURE OF THE PATIENT FROM 300ML TO 500ML BEFORE. THIS RESULTED THAT THE PATIENT HAD TO BE INFUSED WITH SEVERAL BAGS OF PLASMA BLOOD TRANSFUSION. THE ABIOMED IMPELLA PUMP WAS IMPLANTED SUCCESSFULLY AND THE 23F INTRODUCER REMOVED BY MEANS OF PEELING AS PER PROCEDURE (PEEL AWAY). THE PATIENT HAD THE ABIOMED PUMP DEVICES IMPLANTED UNTIL (B)(6). THE HEART AND OF THE PATIENT WORKED NORMALLY AFTER THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 6699576 ↗

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-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-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-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