HVAD Pump Implant AccessoriesRecalls & reported problems across all models

We found 2 models of HVAD Pump Implant Accessories by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HVAD Pump Implant Accessories recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 3, 2021Open, 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-2197-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Jun 3, 2021Open, 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 ↗

3. Apr 3, 2020Open, 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 HVAD Pump Implant Accessories problems

HVAD Pump Implant Accessories models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HVAD® Pump Implant Accessories 1153

  Ventricular (Assisst) Bypass
  2 recalls2 reports
• HVAD® Pump Implant Accessories MCS1753AK

  Ventricular (Assist) Bypass
  1 recall0 reports

Recent HVAD Pump Implant Accessories adverse event reports

The 2 most recent reports across all models, 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 ↗

Other Heartware Inc. products

• HVAD Pump Implant Kit5 models · 5,895 reports · 11 recalls
• HeartWare Battery11 models · 4,241 reports · 5 recalls
• HVAD Controller3 models · 2,990 reports · 5 recalls
• HeartWare Controller2 models · 2,393 reports · 3 recalls
• Patient Pack2 models · 224 reports · 2 recalls
• HeartWare Controller AC Adapter5 models · 97 reports · 3 recalls
• HVAD Pump Outflow Graft3 models · 60 reports · 2 recalls
• HeartWare Controller DC Adapter6 models · 59 reports · 1 recall