HeartWare® Shoulder Pack 2060USRecalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00888707000055), received between Jul 18, 2017 and Jun 9, 2025 — classified as 117 malfunctions.

The most frequently reported specific device problem is “Break” (81 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 16, 2026.

Recalls naming this device

1. Feb 26, 2021Open, 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, 2021Open, 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT THE PIONEER SHOULDER PACK STRAP WAS BROKEN WHERE IT CONNECTS TO THE PACK. THE SHOULDER 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 22171208 ↗
• MalfunctionMay 2, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE SHOULDER PACK WAS INVOLVED IN AN EVENT WHERE THE PLASTIC WINDOW AND SHOULDER STRAP WERE TORN. THE SHOULDER 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 21951451 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT THE STRAPS AND BUCKLE OF THE SHOULDER PACK WERE BROKEN. THE SHOULDER 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 21093289 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK HAD A TORN ZIPPER.  THE SHOULDER 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 18996178 ↗
• MalfunctionFeb 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE SHOULDER PACK.  THE SHOULDER 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 18798489 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK WAS DAMAGED WITH A BROKEN STRAP. THE SHOULDER 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 17916577 ↗
• MalfunctionJun 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHOULDER PACK WAS RIPPED. THE SHOULDER 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 17239087 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT THE METAL PORTION THAT HOLDS THE SHOULDER PACK UP WHEN IT'S OVER THE SHOULDER SNAPPED. THE PATIENT CAUGHT THE PACK BEFORE IT COULD FALL. THE SHOULDER 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 16250325 ↗
• MalfunctionJan 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHOULDER PACK WAS DAMAGED. PER THE SITE, THE BAG WAS TORN. THE CONTROLLER AND BATTERIES REMAINED INTACT AND NEVER FELL OUT. THE SHOULDER 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 16246483 ↗
• MalfunctionJan 12, 2023Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK HAD AN UNSPECIFIED DAMAGE. THE SHOULDER 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 16147057 ↗
• MalfunctionDec 19, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SHOULDER PACK WAS DAMAGED TO THE BOTTOM OF THE BAG. THE PATIENT REPORTED THAT THIS WAS DUE TO REGULAR USE, AND NOTHING INFLICTED TO THE PACK. IT WAS NOTED THAT THE CONTROLLER WINDOW PORTION OF THE BAG WAS DAMAGED AS WELL WITH THE INTERNALPLASTIC EXPOSED TO THE PATIENT. IT WAS STATED THAT THE EXPOSED PLASTIC COULD CAUSE INJURY TO THE PATIENT AND EVENTUAL TOTAL BREAKDOWN OF THE BAG RESULTING IN EQUIPMENT DROPPING OR TUGGING. THE 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 16004756 ↗
• MalfunctionNov 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SHOULDER PACK WAS RIPPED APART AND WAS UNABLE TO HOLD THE PATIENT'S EQUIPMENT PROPERLY. THE 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 15835102 ↗
• MalfunctionOct 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHOULDER PACK WAS DAMAGED AND TORN. THE SHOULDER 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 15668280 ↗
• MalfunctionAug 10, 2022Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK WAS TORN AND COMPLETELY FALLING APART. THE SHOULDER 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 15202056 ↗
• MalfunctionJul 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WAIST PACK WAS DAMAGED. IT WAS FRAYING AND UNUSABLE. THE WAIST PACK WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112632 ↗
• MalfunctionJul 26, 2022Break; Break

  IT WAS REPORTED BY THE PATIENT THAT THE SHOULDER PACK STRAP WAS DAMAGED AND UNUSABLE. THE SHOULDER PACK WAS TAKEN OUT OF SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15106042 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK WAS WORN OUT AND WAS UNABLE TO PROPERLY STAY CLASPED/ADHERED TOGETHER. THE SHOULDER PACK WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14656936 ↗
• MalfunctionJun 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHOULDER PACK HAD TORN. THE SHOULDER 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 14577386 ↗
• MalfunctionMay 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT SHOULDER PACK WAS TORN, RIPPED AND CONSIDERED UNSAFE FOR USE. THE SHOULDER 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 14456917 ↗
• MalfunctionApr 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHOULDER PACK WAS TORN. THE SHOULDER 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 14138894 ↗
• MalfunctionApr 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT SHOULDER PACK HAD RIPS. THE SHOULDER 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 14013706 ↗
• MalfunctionMar 24, 2022Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK WAS THREADBARE AND RIPPED AT THE CORNERS. THE PLASTIC WINDOW WAS ALSO CRACKED AND POKING AT THE PATIENT, AND THE PATIENT SAID IT HURT. THE SHOULDER PACK WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 13893210 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT THE SHOULDER PACK HAD A "BROKEN SCREEN"/THE NETTING ON THE SHOULDER PACK WAS RIPPED. THE SHOULDER 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 13758748 ↗
• MalfunctionFeb 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT SHOULDER PACK WAS DAMAGED, WAS THREADBARE WITH SEVERAL TORN AREAS AND HAD A BROKEN ZIPPER. IT WAS ALSO NOTED THAT THERE WAS A POSSIBILITY THAT A BATTERY OR CONTROLLER COULD FALL OUT OF IT¿S INTENDED LOCATION. THE SHOULDER PACK WAS DISCARDED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549238 ↗
• MalfunctionDec 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHOULDER PACK WAS DAMAGED AS IT WAS RIPPED. THE SHOULDER PACK WAS UNABLE TO SECURELY HOLD THE EQUIPMENT AND IT WAS UNKNOWN IF ANY COMPONENTS FELLS AS THERE WAS A POSSIBILITY THAT THE DEVICES COULD FALL OUT OF IT'S INTENDED LOCATION. THE SHOULDER 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 13054628 ↗