Patient Pack 1475 (UDI 00888707008037)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888707008037), received between Aug 11, 2021 and Jun 17, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

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

58 other recalls cover devices cleared under the same FDA submission (P100047); 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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT'S PACK WAS DAMAGED, AND BOTH CLIPS WERE BROKEN. THE PATIENT 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 22235865 ↗
• MalfunctionMar 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PIONEER CONVERTIBLE PATIENT PACK EXPERIENCED DAMAGE, SPECIFICALLY WITH THE VELCRO BEING FRAYED AND PEELING UP. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT 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 21709488 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT ONE OF THE PLASTIC CLASPS THAT HOLDS THE CONTROLLER IN THE BAG WAS BROKEN ON THE PATIENT PACK. THE PATIENT PACK WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567658 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT THE CARRYING CASE BUCKLE BROKE. THE CARRYING CASE 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 18773549 ↗
• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT PACK WAS COMPLETELY TORN. THE PATIENT 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 16610720 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT THE "SECUREMENT CLIP" ON THE PATIENT PACK WAS BROKEN. THE PATIENT PACK WAS REMOVED FROM SERVICE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246866 ↗
• MalfunctionJan 18, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE CLIP ON THE PATIENT PACK WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195739 ↗
• MalfunctionDec 20, 2022Break; Break

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED ISSUE WITH THE PATIENT PACK. THE PATIENT 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 16016835 ↗
• MalfunctionDec 12, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED AS THE CLIP TO CLOSE THE BAG WAS BROKEN. THE PATIENT 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 15963305 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT PACK BROKE. THE PATIENT 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 14987886 ↗
• MalfunctionMar 7, 2022Break; Break

  IT WAS REPORTED THAT SHOULDER PACK HAD A BROKEN SHOULDER STRAP CLIP. 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 13677842 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT THE PLASTIC CLIP ON THE PATIENT PACK WAS BROKEN. THE PATIENT 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 13591375 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT THE STRAP ON THE PATIENT PACK BROKE, AND THE PATIENT WAS UNABLE TO SAFELY CARRY EQUIPMENT. THE PATIENT 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 13506997 ↗
• MalfunctionDec 1, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE VELCRO ON THE PATIENT PACK WAS TORN AND PEELING AWAY. THE PATIENT 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 12911221 ↗
• MalfunctionOct 13, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED, IT HAD TEARS IN MULTIPLE PLACES. THE PATIENT 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 12624100 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE PATIENT PACK AND IT WAS TEARING AND UNABLE TO SUPPORT THE EQUIPMENT PROPERLY. THE PATIENT 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 12366186 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT PATIENT PACK HAD A BROKEN CLIP. THE PATIENT 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 12337418 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE CLIPS ON THE PATIENT PACK BROKE. THE PATIENT 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 12307675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100047. One submission often covers many models, so check the product and lot details in each record.

• Z-0475-2024 · Oct 31, 2023 · Open, Classified
  HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
• Z-1993-2023 · May 16, 2023 · Open, Classified
  HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
• Z-1512-2022 · Jun 28, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
• Z-1266-2022 · May 5, 2022 · Open, Classified
  HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
• Z-1207-2022 · Apr 14, 2022 · Open, Classified
  HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• Z-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• Z-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1107-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) H
• Z-1110-2022 · Mar 30, 2022 · Open, Classified
  Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump
• Z-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-0726-2022 · Jan 27, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System
• Z-2478-2021 · Aug 6, 2021 · Open, Classified
  Medtronic HVAD Pump Implant Kits
• Z-2195-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Implant Kit, REF MCS1705PU

…and 43 more.