Patient PackRecalls & reported problems across all models
Heartware Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Patient Pack model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 224
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of Patient Pack by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 224 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2017 and Jun 17, 2025 — classified as 224 malfunctions.
The most frequently reported specific device problem is “Break” (194 reports).
2 FDA recall records name at least one of these models by its device 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. 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
Reports received per month, all models
Patient Pack 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.
- 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 ↗
- 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 Patient Pack problems
Device problems
- Break194
- Material Split, Cut or Torn19
- Material Integrity Problem8
- Adverse Event Without Identified Device or Use Problem2
- Component Missing2
- Device Fell2
- Material Frayed2
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient132
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient30
- No Patient Involvement13
- Bruise/Contusion1
- Erythema1
Patient Pack models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Patient Pack 1475Ventricular (Assisst) Bypass206 reports
- Patient Pack 1475Ventricular (Assist) Bypass2 recalls18 reports
Recent Patient Pack adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CONTROLLER DISPLAY PART OF THE PIONEER CONVERTIBLE PATIENT PACK WAS TORN. THE PATIENT PACK WAS REPLACED BY A MEDTRONIC PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20843695 ↗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 ↗MalfunctionNov 15, 2023Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED, THE CLIP WAS BROKEN. THE PATIENT'S 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 18139537 ↗MalfunctionMar 24, 2023Break; Break
IT WAS REPORTED THAT CLIP ON THE PATIENT PACK BROKE. THE PATIENT 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 16610874 ↗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 ↗MalfunctionSep 20, 2022Break; Break
IT WAS REPORTED THAT THE 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 15455780 ↗MalfunctionSep 20, 2022Break; Break
IT WAS REPORTED THAT THE PATIENT PACK CLIP 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 15455719 ↗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 ↗
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
- HeartWare Controller AC Adapter5 models · 97 reports · 3 recalls
- HVAD Pump Outflow Graft3 models · 60 reports · 2 recalls
- HVAD Pump Implant Accessories2 models · 2 reports · 3 recalls
- HeartWare Controller DC Adapter6 models · 59 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page