HeartWare Controller DC AdapterRecalls & reported problems across all models
Heartware Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one HeartWare Controller DC Adapter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 6 models of HeartWare Controller DC Adapter by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2017 and Sep 5, 2023 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Power Problem” (35 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
HeartWare Controller DC Adapter 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.
- May 2, 2018Open, Classified
Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
Z-1903-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
Most reported HeartWare Controller DC Adapter problems
Device problems
- Power Problem35
- Connection Problem13
- Material Integrity Problem12
- Material Split, Cut or Torn3
- Component Missing1
- Device Operates Differently Than Expected1
- Disconnection1
- Display or Visual Feedback Problem1
Patient problems
- No Known Impact Or Consequence To Patient25
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient17
- Dizziness1
- No Patient Involvement1
HeartWare Controller DC Adapter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HeartWare® Controller DC Adapter 1435Ventricular (Assisst) Bypass1 recall21 reports
- HeartWare® Controller DC Adapter 1440Ventricular (Assisst) Bypass1 recall19 reports
- HeartWare® Controller DC Adapter 1440Ventricular (Assisst) Bypass1 recall8 reports
- HeartWare® Controller DC Adapter 1440Ventricular (Assist) Bypass7 reports
- HeartWare® Controller DC Adapter 1440Ventricular (Assist) Bypass3 reports
- HeartWare® Controller DC Adapter 1440Ventricular (Assist) Bypass1 report
Recent HeartWare Controller DC Adapter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CONTROLLER DC (CDC) ADAPTER WAS DAMAGED, THE FRONT PART WAS SEPARATED. THE CDC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17683828 ↗MalfunctionMay 25, 2023Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER ADAPTER (CDC) DOES NOT PROVIDE POWER. THE CDC 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 17004879 ↗MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER CABLE WAS DAMAGED. THE CONNECTION PART OF THE CABLE WAS TORN BY THE PATIENT'S MISTAKE. THE CONTROLLER DC ADAPTER 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 16140972 ↗MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER CABLE WAS DAMAGED. A PART OF THE CABLE WAS TORN SLIGHTLY BY THE PATIENT'S MISTAKE. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16140792 ↗MalfunctionJan 11, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CDC ADAPTER EXHIBITED A DAMAGED CABLE. THE PLASTIC PART OF THE CONNECTION WAS SLIGHTLY BROKEN BY THE PATIENT. THE CDC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16139192 ↗MalfunctionDec 15, 2022Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT A PART OF THE CONTROLLER DC ADAPTER CABLE WAS TORN BY THE PATIENT'S MISTAKE. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987004 ↗MalfunctionDec 15, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC (CDC) ADAPTER WAS DAMAGED, A PART OF THE CABLE WAS TORN ACCIDENTALLY BY THE PATIENT. THE CDC CABLE WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15986645 ↗MalfunctionMay 18, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT CONTROLLER DC (CDC) ADAPTER CABLE WAS BROKEN. THE CDC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14429884 ↗MalfunctionMay 12, 2022Material Integrity Problem; Power Problem; Material Integrity Problem; Power Problem
IT WAS REPORTED THAT THE END OF THE CONTROLLER DC ADAPTER THAT FITS INTO THE CAR OUTLET WAS BROKEN OFF AND NO LONGER PROVIDED POWER. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14380174 ↗MalfunctionDec 2, 2021Misassembled; Use of Device Problem; Misassembled; Use of Device Problem
THE CONTROLLER DC ADAPTER WAS RETURNED TO THE MANUFACTURER BECAUSE IT WAS UNASSEMBLED WHEN THE BOX WAS OPENED. THE CONTROLLER DC ADAPTER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12920653 ↗MalfunctionAug 25, 2021Connection Problem; Power Problem; Connection Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER CDC ADAPTER WAS NOT PROVIDING POWER DUE TO THE MIDDLE PIN OF THE CHARGING CONNECTOR BROKE AND FELL OUT. THE ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366045 ↗MalfunctionJun 30, 2021Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER DC (CDC) ADAPTER WAS NOT PROVIDING POWER. THE CDC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12094683 ↗MalfunctionApr 6, 2021Mechanical Problem; Connection Problem; Power Problem; Mechanical Problem; Connection Problem; Power Problem
IT WAS FURTHER REPORTED THAT THE CONTROLLER DC ADAPTER WAS LOOSE AT THE CONNECTION WHERE IT PLUGS INTO THE CAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11619995 ↗MalfunctionMar 9, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CDC ADAPTER FELL FROM THE PATIENT'S HAND AND THE ADAPTER CABLE WAS DAMAGED. THE ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11445793 ↗MalfunctionNov 23, 2020Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER DID NOT PROVIDE POWER WHEN CONNECTED. THE CONTROLLER DC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10886450 ↗
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
- HVAD Pump Implant Accessories2 models · 2 reports · 3 recalls
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.
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