HeartWare Controller AC AdapterRecalls & reported problems across all models
Heartware Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one HeartWare Controller AC Adapter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 5 models of HeartWare Controller AC Adapter by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Apr 1, 2016 and Jan 30, 2025 — classified as 97 malfunctions.
The most frequently reported specific device problem is “Power Problem” (57 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
HeartWare Controller AC 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.
- 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 ↗
- 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 AC Adapter problems
Device problems
- Power Problem57
- Material Integrity Problem17
- Connection Problem15
- Material Deformation4
- Break3
- Device Difficult to Setup or Prepare3
- Appropriate Device Problem Term/Code Not Available1
- Complete Loss of Power1
Patient problems
- No Known Impact Or Consequence To Patient44
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient22
- No Patient Involvement5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
HeartWare Controller AC Adapter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HeartWare® Controller AC Adapter 1430USVentricular (Assisst) Bypass3 recalls10 reports
- HeartWare® Controller AC Adapter 1425USVentricular (Assisst) Bypass1 recall36 reports
- HeartWare® Controller AC Adapter 1430USVentricular (Assisst) Bypass1 recall25 reports
- HeartWare® Controller AC Adapter 1430USVentricular (Assist) Bypass20 reports
- HeartWare® Controller AC Adapter 1430USVentricular (Assist) Bypass6 reports
Recent HeartWare Controller AC Adapter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PIONEER CAC ADAPTER, SPECIFICALLY THE ADAPTER 1430US CONTROLLER AC, ARRIVED WITH A DAMAGED CABLE, DESCRIBED AS HAVING "A CUT IN IT." THE PRODUCT WAS NOT IMPLANTABLE AND WAS NOT ASSOCIATED WITH A PATIENT. CUSTOMER SERVICE ISSUED A REPLACEMENT PRODUCT AND INSTRUCTED THE SITE TO DISCARD THE DAMAGED PRODUCT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21275586 ↗MalfunctionMar 5, 2024Power Problem; Power Problem
IT WAS REPORTED THAT TWO CONTROLLER AC ADAPTERS DID NOT PROVIDE POWER TO THE CONTROLLER. THE CAC WERE DISCONNECTED AND RE-TIGHTENED WHERE THE AC ADAPTER CONNECTS TO THE WALL PLUG, BOTH CAC WITHOUT EFFECT AND CONTINUED TO SHOW THAT THE CONTROLLER WAS NOT CONNECTED TO POWER. NO DAMAGE TO EITHER POWER CORDS, OR ALARMS WERE NOTED. PATIENT REPORTS THAT THE INITIAL ADAPTER FAILED AND TURNED TO THE BACK UP CAC ADAPTER, WHICH ALSO WASN'T WORKING. IT DID NOT MATTER WHICH PORT ON THE CONTROLLER WAS USED THE CAC ADAPTERS DID NOT FUNCTIONED. THE CAC ADAPTERS WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18837312 ↗MalfunctionJan 8, 2024Material Integrity Problem; Power Problem; Material Integrity Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER WAS NOT PROVIDING POWER TO THE CONTROLLER RESULTING IN A POWER DISCONNECT ALARM, EVEN THOUGH THERE WAS A GREEN LIGHT ILLUMINATED. THE PATIENT FELT THERE MUST HAVE BEEN DAMAGE TO THE JUNCTION OF THE CAC ADAPTER CABLE AND PLUG AND ATTRIBUTED THIS TO USING A "SLEEPING BELT" DEVICE WHICH WAS PURCHASED ONLINE BY A COMPETITOR MANUFACTURER, WHICHALLOWS FOR THE CABLE TO BEND ALMOST NINETY (90) DEGREES WHEN THE PATIENT SIDE SLEEPS. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE CAC ADAPTER OR CONNECTOR PLUG. THE CAC ADAPTER WAS REPLACED AND DISCARDED BY THE SITE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18466782 ↗MalfunctionAug 31, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF HOSPITAL-OWNED EQUIPMENT, IT WAS NOTED THAT THE CONTROLLER AC ADAPTERS HAD DAMAGED CABLES AND EXPOSED WIRES. THE CONTROLLER AC ADAPTERS WERE REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17662239 ↗MalfunctionJul 25, 2023Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER DID NOT PROVIDE POWER. IT WAS NOTED THAT THE CAC ADAPTER ¿DID NOT WORK¿ AND IT WAS ¿BROKEN¿. THE CAC 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 17393576 ↗MalfunctionJun 22, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER CABLE WAS DAMAGED. THE CAC 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 17181765 ↗MalfunctionJun 21, 2023Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER (CAC) EXHIBITED AN UNSTABLE MECHANICAL CONNECTION. IT WAS OBSERVED THAT THE ADAPTER WAS LOOSE AND DISCONNECTED WITHOUT ANY MOVEMENT. THE CAC ADAPTER 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 17171896 ↗MalfunctionMay 19, 2023Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER WAS NOT PROVIDING POWER. THE CONTROLLER AC 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 16961698 ↗MalfunctionMay 16, 2023Power Problem; Insufficient Device Problem Information; Power Problem; Insufficient Device Problem Information
IT WAS FURTHER REPORTED THAT THE CORD WOULD NOT SUPPLY POWER TO THE CONTROLLER AND MULTIPLE OUTLETS WERE TRIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16942559 ↗MalfunctionApr 13, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE SITE RECEIVED THE CONTROLLER AC ADAPTER (CAC) AS NEW IN THE BOX AND THE SCREW HOLDING THE ELECTRICAL CORD WAS MISSING. THE CAC ADAPTER WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16736973 ↗MalfunctionFeb 27, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER HAD A DAMAGED CABLE, AND THE WIRES WERE FRAYED. THE CAC ADAPTER WILL BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16443770 ↗MalfunctionFeb 14, 2023Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER "COULD NOT CONNECT TO A POWER SOURCE" DESPITE THERE BEING NO BENT PINS IN EITHER POWER SOURCE PORT. THE CAC ADAPTER HAS BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16375531 ↗MalfunctionFeb 14, 2023Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER DID NOT PROVIDE POWER. WHEN THE CAC ADAPTER WAS PLUGGED IN NO GREEN LIGHT INDICATED THAT THE ADAPTER WAS RECEIVING POWER FROM THE OUTLET. THE CONTROLLER ALSO DID NOT RECOGNIZE THE CAC ADAPTER AND A "RECONNECT POWER" ALARM CAME ON. IT WAS NOTED THAT THE CAC ADAPTER SHOWED NO SIGNS OF DAMAGE OR BENT PINS. THE CAC ADAPTER HAS BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16375514 ↗MalfunctionFeb 10, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER CABLE WAS DAMAGED OUT OF THE BOX. THE CABLE WILL BE REPLACED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16353178 ↗MalfunctionJan 26, 2023Power Problem; Power Problem
IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER WAS NOT PROVIDING POWER. IT WAS NOTED THAT IT WAS INITIALLY CONFIRMED THAT THE POWER CORD WAS FULLY ENGAGED WITH THE ADAPTER. THE PATIENT WAS LATER ABLE TO PUSH THE CORD OF THE CAC ADAPTER IN FURTHER AND FULLY ENGAGE THE CORD INTO THE CAC ADAPTER, AND THE CAC ADAPTER WAS THEN FUNCTIONING PROPERLY. THE CAC ADAPTER 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 16246651 ↗
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
- 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.
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