HeartWare® Controller DC Adapter 1435Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888707000109), received between Aug 10, 2017 and Apr 4, 2018 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Power Problem” (12 reports).

1 FDA recall record name this device's 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, 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER DID NOT PROVIDE POWER. MULTIPLE DC OUTLETS AND CARS WERE ATTEMPTED. THE DC ADAPTER WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395958 ↗
• MalfunctionJan 8, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER TO THE CONTROLLER. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7171265 ↗
• MalfunctionDec 28, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC ADAPTER DID NOT STAY RELIABLY CONNECTED FOR CHARGING AND WOULD SLIP OUT OF THE CHARGER. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150994 ↗
• MalfunctionDec 28, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER WAS NO LONGER PROVIDING POWER TO THE CONTROLLER. THE CONTROLLER DC ADAPTER WAS TAKEN OUT OF SERVICE AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150425 ↗
• MalfunctionDec 22, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC ADAPTER WOULD ONLY WORK INTERMITTENTLY. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7144041 ↗
• MalfunctionDec 22, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER DID NOT MAKE A SMOOTH EASY SNAP ON CONNECTION. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7143478 ↗
• MalfunctionNov 22, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER WAS NOT FITTING PROPERLY INTO A CAR POWER OUTLET, AND THAT IT WOULD ONLY GIVE POWER I INTERMITTENTLY. THE CONTROLLER DC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7054580 ↗
• MalfunctionNov 22, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT CONTROLLER DC (CDC) ADAPTER NO LONGER WORKED, AND DIFFERENT OUTLETS WERE TRIED WITHOUT LUCK. THE CDC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7054327 ↗
• MalfunctionNov 20, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT NOTICED DAMAGE TO DC ADAPTER CONNECTOR. THE DAMAGE TO THE CONNECTOR PREVENTED A SECURE CONNECTION. THE PATIENT DISCONTINUED USE OF THE ADAPTER. THERE WERE NO REPORTED PATIENT CONSEQUENCES ASSOCIATED WITH THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047185 ↗
• MalfunctionOct 13, 2017Connection Problem; Connection Problem

  DURING A ROUTINE FOLLOW UP AT THE CLINIC, THE PATIENT REPORTED THAT WHEN USING THE CONTROLLER DC ADAPTER THE LOCKING MECHANISM DOES NOT ENGAGE PROPERLY AND THE CONTROLLER DC ADAPTER BECOMES DISCONNECTED FROM THE CONTROLLER EASILY. THE CONTROLLER DC ADAPTER WAS TAKEN OUT OF SERVICE AND THE PATIENT WAS ISSUED A NEW CONTROLLER DC ADAPTER. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949740 ↗
• MalfunctionOct 10, 2017Connection Problem; Connection Problem

  IT WAS REPORTED BY THE VAD TEAM AT A US SITE THAT THE PATIENT REPORTED THAT THE DC ADAPTER DOES NOT WORK. HE COULD NOT GET A SECURE CONNECTION WITH THE END THAT PLUGS INTO THE CONTROLLER. THE BATTERIES AND AC ADAPTER PLUG IN JUST FINE. A NEW DC ADAPTER WAS PROVIDED TO THE PATIENT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6938374 ↗
• MalfunctionOct 10, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT PT SEEN IN CLINIC ON (B)(6) 2015 REPORTING THAT DC ADAPTER WAS NO LONGER PROVIDING POWER TO CONTROLLER. THE ADAPTOR WAS REPLACED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6937881 ↗
• MalfunctionOct 6, 2017Power Problem; Power Problem

  DURING A CLINIC VISIT, IT WAS REPORTED BY THE PATIENT THAT THE CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER. THE PATIENT ALSO STATED THAT THE DC IN THE CAR WORKED TO POWER OTHER ITEMS. THE CONTROLLER DC ADAPTER WAS REPLACED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6921217 ↗
• MalfunctionSep 28, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO USE THEIR CONTROLLER DC ADAPTER TO PROVIDE POWER TO THE HVAD IN THE CAR, HOWEVER, THE CHARGER WOULD NOT STAY SECURED IN THE OUTLET. THERE WERE NO REPORTED PATIENT CONSEQUENCES ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902918 ↗
• MalfunctionSep 27, 2017Power Problem; Power Problem

  IT WAS REPORTED THE CONTROLLER DC WAS NOT PROVIDING POWER. THE CONTROLLER DC ADAPTER WAS EXCHANGED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899623 ↗
• MalfunctionSep 26, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WAS PLUGGED INTO HIS CONTROLLER DC ADAPTER AND DID NOT REALIZE THE CABLE WAS SHORT IN LENGTH. THE PATIENT TRIED TO WALK FURTHER AWAY THAN THE CABLE WOULD ALLOW AND BROKE THE CABLE. THE CONTROLLER DC ADAPTER WAS TAKEN OUT OF SERVICE, THE PATIENT IS NOW VERY AWARE OF THE LENGTH OF THE CABLE. A NEW CONTROLLER DC ADAPTER, (B)(4)  WAS ISSUED TO THE PATIENT WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6896087 ↗
• MalfunctionSep 24, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME ISSUES WITH HIS CONTROLLER DC ADAPTER. THE PATIENT CLAIMED THAT THE DEVICE WAS NOT WORKING CORRECTLY AND THAT THERE WAS SOMETHING LOOSE IN IT. THERE WERE NO REPORTED PATIENT CONSEQUENCES ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6889219 ↗
• MalfunctionSep 14, 2017Power Problem; Power Problem

  IT WAS REPORTED BY THE VAD TECHNICIAN THAT THE DC ADAPTER WOULD STOP PROVIDING POWER TO THE CONTROLLER A LITTLE WHILE AFTER BEING PLUGGED IN. THE ADAPTER WAS REMOVED FROM SERVICE WITH NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866415 ↗
• MalfunctionSep 13, 2017Power Problem; Power Problem

  IT WAS REPORTED BY THE COORDINATOR THAT THE PATIENT COMPLAINED OF DC ADAPTER NOT WORKING. THE DEVICE WAS EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6863418 ↗
• MalfunctionAug 29, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT'S CAR DC ADAPTER WAS NOT FUNCTIONING.  THIS IS NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.  THE REDUNDANT POWER SOURCE WILL CONTINUE TO SUPPLY POWER TO THE PUMP.  THIS FAILURE WILL RESULT IN USER ANNOYANCE AND WILL NOT AFFECT THE FUNCTION OF THE PUMP. THE BAC IS NOT CONNECTED TO THE PUMP SYSTEM AND WILL NOT EFFECT THE FUNCTIONING OF THE PUMP.  NO CONSEQUENCE TO PATIENT.  NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6828936 ↗
• MalfunctionAug 10, 2017Connection Problem; Connection Problem

  A REPORT WAS RECEIVED FROM THE CLINICAL DATABASE THAT THE PATIENT HAD ISSUES WITH THE CDC ADAPTER REMAINING CONNECTED TO THE CONTROLLER. THE CDC ADAPTER NO LONGER CONNECTS AT ALL. THE CDC ADAPTER WAS REPLACED WITH NO REPORTED PATIENT CONSEQUENCE. THE EVENT RESOLVED WITH THE REPLACEMENT DEVICE. THE CONTROLLER POWER CONNECTORS WERE REPORTEDLY NOT DAMAGED. THE SITE WAS UNABLE TO PROVIDE INFORMATION ABOUT WHETHER THE CONNECTORS OF THE CDC ADAPTER WERE DAMAGED. THERE WAS A BATTERY CONNECTED TO THE OPPOSING POWER PORT OF THE CONTROLLER AT THE TIME OF THE REPORTED EVENT. THE EVENT WAS NOT ASSOCIATED WITH ANY CONTROLLER ALARMS OR PUMP STOPS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6786905 ↗