Introducer Kit for Impella® 0052-3025 (UDI 00885672009793)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885672009793), received between Mar 3, 2020 and Sep 30, 2026 — classified as 5 injuries, 5 malfunctions.

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

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

3 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.

Recalls naming this device

1. Jun 10, 2026Class IOpen, Classified

   Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

   Z-2678-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Contamination

  It was reported that the affected component was the introducer kit. The time of occurrence was unknown. This issue was identified during use of the Impella CP pump. A 16 Fr. sheath was used. There was no patient impact. During use of the Impella CP, multiple water droplets were observed around the dilator coated with silicone lubricant within the introducer kit. Water droplets were also noted on the outside of the tube covering the dilator. As a 16 Fr sheath is routinely used at the facility, there was no impact on the procedure. The pump, purge cassette, and guidewire were all used without issue. The product had been stored in the catheterization laboratory under the facility's standard storage conditions. Additional information was provided which indicated that the hospital indicated that the bag had a sticky residue on it. The device was examined and found it to be slightly sticky as well. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948616 ↗
• MalfunctionMay 6, 2026Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. SEVERE TORTUOSITY MADE THE IMPELLA INSERTION DIFFICULT. THE INSERTION WAS ABANDONED. THE PATIENT'S OUTCOME IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095323 ↗
• MalfunctionMay 1, 2026Break

  CUSTOMER REPORTED THAT THE CLEAR PLASTIC RING ON THE HUB OF THE 14FR DILATOR HAS BECOME SEPARATED FROM THE DILATOR DURING DILATOR REMOVAL FROM THE PEEL AWAY SHEATH. THE PHYSICIAN HAS THEN REMOVED THE PEEL AWAY SHEATH AT THE COMPLETION OF THE IMPLANT WITH THE CLEAR RING STILL ATTACHED. SHE HAS THEN SEPARATED THE TWO IN ORDER TO PEEL AWAY THE SHEATH BUT THE CLEAR RING HAS THEN BEEN LEFT OVER THE IMPELLA CATHETER ITSELF AND NEEDED TO BE CUT OFF. UNCLEAR IF IT WAS PHYSICALLY BROKEN DURING IMPLANT OR MANUFACTURING ERROR. THERE WAS NO PATIENT HARM AND THE PATIENT REMAINS ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059844 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 75 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH THE INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE PATIENT PRIOR TO THE CP WAS SUPPORTED BY AN INTRA-AORTIC BALLOON PUMP (IABP) AND EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO), VASOPRESSORS, INOTROPES, AND A VENT FOR RESPIRATORY NEEDS. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS PLACED AS CARE ESCALATION FROM THE IABP AT THE SAME ACCESS SITE. THE SITE DEVELOPED A HEMATOMA THAT GREW IN SIZE AND PROMPTED BLOOD PRODUCTS, SURGICAL SUTURE, AND PUMP EXPLANT. THE TEAM THEN HAD THE PATIENT SUPPORTED BY ECMO ONLY. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. PATIENT SURVIVED THE HEMATOMA.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24544788 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT WHILE DURING IMPLANTATION OF AN IMPELLA PUMP THE GUIDEWIRE THE SHEATH BROKE DURING REMOVAL, CAUSING BLEEDING. THE 14 FR SHEATH WAS REPLACED WITH A 16 FR SHEATH TO RESOLVE THE BLEEDING. THE PATIENT WAS IN CRITICAL CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24455619 ↗
• InjuryDec 23, 2025Difficult to Advance; Difficult to Advance

  ON 26/JAN/2026 CUSTOMER REPORTED; THE FIELD REP HAS STATED THE PRODUCT WAS DISCARDED.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 23878907 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PRESENTED TO THE EMERGENCY DEPARTMENT WITH AN ST-ELEVATION MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK PROCEDURE WHEN PRESENTED TO THE PHYSICIAN WHICH ATTEMPTED TO DELIVER A 14 FR INTRODUCER DEVICE, HOWEVER, INSERTION WAS ULTIMATELY ABORTED AFTER THE DEVICE BECAME DAMAGED DUE TO PATIENT'S CALCIFIED VASCULATURE. IT WAS NOTED THAT THE COMMON FEMORAL ARTERY WAS DISSECTED WHILE ATTEMPTING TO ACCESS. AS A RESULT, THE INTRODUCER WAS REMOVED AND AN INTRA-AORTIC BALLOON PUMP WAS PLACED. PATIENT REPORTED AS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 14592271 ↗
• MalfunctionSep 3, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT ON (B)(6) 2020 A (B)(6) MALE UNDERWENT A PROCEDURE FOR INSERTION OF AN IMPELLA CP AT THE RIGHT FEMORAL ARTERY VIA THE 14FR X 13CM INTRODUCER. THE PHYSICIAN HAD A DIFFICULT TIME CRACKING THE PEEL AWAY SHEATH OUTSIDE OF THE BODY. THE PHYSICIAN USED A SCALPEL TO CAREFULLY CUT THE PEEL AWAY SHEATH. THE ISSUE WAS RESOLVED BY PLACEMENT OF THE IMPELLA AND REMOVAL OF THE INTRODUCER. THE PATIENT WAS ADMITTED WITH CANCER, FLU LIKE SYMPTOMS, AND A VF ARREST. THERE WAS NO PATIENT HARM REPORTED, HOWEVER, THE PATIENT EXPIRED WHEN THE FAMILY CHOSE TO WITHDRAW CARE ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421682 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CARDIOGENIC SHOCK PROCEDURE, THERE WAS BLEEDING AT THE INSERTION SITE. USER REPORTED THAT THERE WAS NO ISSUE WITH INTRODUCER. THEY NOTICED EXCESSIVE BLEEDING AFTER GIVING HEPARIN FOR ANTICOAGULATION ONCE THE SHEATH WAS IN. THE FIRST CP WAS PLACED HAD EXCESSIVE BLEEDING IN THE RIGHT GROIN. THEN THE SECOND CP WAS PLACED IN THE LEFT GROIN ONCE THE FIRST CP WAS REMOVED FROM THE SHEATH. PATIENT LOSS 800ML BLOOD. TWO (2) UNITS OF RED BLOOD CELLS (RBCS) WERE GIVEN AND GORE SHEATH WAS PLACED FOR HEMOSTASIS IN RIGHT GROIN AND NEW CP IN LEFT GROIN. THE SHEATH WAS SUTURED TO THE SKIN. THE BLEEDING CAUSED A DELAY IN PUTTING THE RP IN, WHICH WE NEVER GOT TO BECAUSE OF THE CONDITION OF THE PATIENT. PATIENT WAS VERY SICK. PATIENT EXPIRED ON 22ND FEBRUARY FROM CARDIAC ARREST. THE PATIENT WAS IN CARDIAC STANDSTILL. THERE WAS NO PRODUCT MALFUNCTION REPORTED. DEVICE WAS DISCARDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss; Cardiac Arrest

  MAUDE report 9850021 ↗
• InjuryMar 3, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  DURING PRIMARY PERCUTANEOUS CORONARY INTERVENTION 14 FR X 23 CM INTRODUCER THAT KINKED. THE PHYSICIAN PLACED 2 COVERED STENTS IN THE ILIACS AFTER HE SAW HOW BENT THE INTRODUCER WAS JUST TO MAKE SURE THERE WAS NO INTERNAL BLEEDING. THERE WAS NO INTERNAL DAMAGE, COVERED STENTS WERE PLACED AS PRECAUTION. THERE WAS 30- 45 MIN DELAY REPORTED TO PLACE COVERED STENTS AND CHANGING DEVICES. PROCEDURE WAS NOT COMPLETED AND PATIENT OUTCOME IS STABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781630 ↗

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-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