HVAD® Pump Implant Accessories 1153Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888707000147), received between Dec 5, 2018 and Jul 6, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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 3, 2021Class IOpen, Classified

   Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

   Z-2191-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Apr 3, 2020Class IOpen, Classified

   The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

   Z-2059-2020 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionJul 6, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE IMPLANT KIT BECAME UNSTERILE WHILE UNPACKING. THE IMPLANT KIT WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10233309 ↗
• MalfunctionDec 5, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN ASSEMBLING THE OUTFLOW GRAFT STRAIN RELIEF TO THE VENTRICULAR ASSIST DEVICE (VAD), THE PERFUSIONIST STARTED TO TIGHTEN THE SCREW AND THE SCREW HEAD BROKE. IT WAS NOTED THAT THE SCREW WAS NOT OVERTIGHTENED. THE STRAIN RELIEF WAS REPLACED WITH A NEW STRAIN RELIEF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135391 ↗