HeartWare® Waist Pack 2050USRecalls & reported problems

Summary

The FDA's MAUDE database contains 435 adverse event reports that list this exact device (DI 00888707000048), received between Dec 21, 2017 and Feb 4, 2026 — classified as 435 malfunctions.

The most frequently reported specific device problem is “Break” (211 reports).

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. Feb 26, 2021Class IIOpen, Classified

   IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

   Z-1438-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 26, 2021Class IIOpen, Classified

   IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

   Z-1469-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 435 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED. THE WAIST PACK STITCHING WAS COMING OUT. THE WAIST PACK WAS REMOVED FROM USE. NO PA TIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259747 ↗
• MalfunctionJul 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC AND REQUESTED A REPLACEMENT WAIST PACK AS IT "IS BROKEN". NO COMPONENTS FELL NOR IS THERE A POSSIBILITY FOR THE CONTROLLER TO FALL OUT OF THE INTENDED LOCATION AND THE DRIVELINE WAS NOT DISCONNECTED AS A RESULT OF THE PACK BEING BROKEN. NO FURTHER DETAILED INFORMATION IS AVAILABLE REGARDING THE BROKEN PACK AND THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652635 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A PIONEER WAIST PACK. THE FABRIC OF THE BATTERY AND CONTROLLER POCKETS, THROUGH WHICH THE WAIST STRAP GOES, WAS COMPLETELY TORN. THE PRODUCT WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893120 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS TORN. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060814 ↗
• MalfunctionJul 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAIST PACK WAS DAMAGED. THE PATIENT COMPLAINED OF TEARS IN THE WAIST PACK. THE WAIST PACK WAS REMOVED FROM SERVICE; HOWEVER, THE PATIENT REQUESTED TO KEEP THE WAIST PACK AND DECLINED TO RETURN IT AT THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781050 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS FURTHER REPORTED THAT THE WAIST PACK POUCH WAS RIPPED AT THE SEAMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484551 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS RIPPED. THE WAIST PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355103 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAIST PACK WAS RIPPED.  THE WAIST PACK WAS REMOVED FROM USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182068 ↗
• MalfunctionMar 13, 2024Break; Device Fell; Break; Device Fell

  IT WAS REPORTED THAT THE WAIST PACK WAS TORN ALLOWING THE BATTERY TO FALL OUT. THE WAIST PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896172 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED, WITH TEARS AT THE SEAMS, AND A POSSIBILITY OF THE BATTERY OR CONTROLLER COULD FALL OUT OF ITS INTENDED LOCATION. THE WAIST PACK WAS REPLACED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498026 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED, THE MAIN CONTROLLER COMPARTMENT WAS RIPPED. THE WAIST PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466233 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT THE WAIST PACK BATTERY POCKETS WERE TORN. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348376 ↗
• MalfunctionAug 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED WITH TEARS. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608340 ↗
• MalfunctionAug 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED. ¿THE BELT WAS SEPARATED FROM THE PACK PART OF THE WAIST PACK¿. THE WAIST PACK REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558085 ↗
• MalfunctionJul 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE WAIST PACK HAD SIGNIFICANT AMOUNT OF WEAR TO THE MATERIAL AND SEAMS REQUIRING IT TO BE HELD TOGETHER WITH DUCT TAPE. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373047 ↗
• MalfunctionJun 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED AND HELD TOGETHER WITH SAFETY PINS. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240549 ↗
• MalfunctionJun 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WAIST PACK WAS WORN WITH FRAYED AREAS. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154534 ↗
• MalfunctionJun 16, 2023Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS RIPPING ALONG THE WAIST STRAP. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144271 ↗
• MalfunctionJun 15, 2023Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS TORN.  THE WAIST PACK WAS REPLACED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139631 ↗
• MalfunctionJun 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WAIST PACK WAS RIPPED. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119936 ↗
• MalfunctionMay 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WAIST PACK WAS TORN AND FRAYED IN A FEW DIFFERENT SPOTS. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003159 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT THE CONTROLLER POCKET OF THE WAIST PACK WAS TORN. THE WAIST PACK IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942511 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT THE WAIST PACK EXHIBITED A DAMAGE AND HAD A TEAR ON THE CONTROLLER POCKET. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940476 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT THE WAIST PACK WAS RIPPING ALONG THE WAIST STRAP. THE WAIST PACK WAS REMOVED FROM USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912162 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT'S WAIST PACK WAS BROKEN. THE WAIST PACK WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872061 ↗