HeartWare® Controller AC Adapter 1425USRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00888707000093), received between Apr 1, 2016 and Jan 22, 2018 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Power Problem” (21 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER CABLE WAS FRAYED AND HAD MULTIPLE TEARS ON THE OUTER INSULATION. THE AC 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 7209281 ↗
• MalfunctionDec 28, 2017Power Problem; Power Problem

  IT WAS REPORTED BY THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR THAT THE LIGHT EMITTING DIODE (LED) LIGHT OF THE CONTROLLER AC ADAPTER WAS NOT WORKING. NO ALARMS WERE TRIGGERED. THE DEVICE WAS EXCHANGED WITHOUT REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152994 ↗
• MalfunctionDec 28, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT'S AC ADAPTER WAS NOT PROVIDING POWER TO THE CONTROLLER. IT WAS MENTIONED THAT THE METAL CLAMP WAS REMOVED TO RE-ESTABLISH A CONNECTION BUT THE ACTION WAS UNSUCCESSFUL. THE ADAPTER WAS EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152695 ↗
• MalfunctionDec 28, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT WHILE THE PATIENT WAS SLEEPING, THE CONTROLLER'S POWER SOURCE SWITCHED FROM THE AC ADAPTER TO A BATTERY. THE PATIENT WAS AWAKEN BY A LOW PRIORITY ALARM. THE CLINICAL SPECIALIST TRIED SOLVING THE ISSUE OVER THE PHONE BUT THE ATTEMPT WAS UNSUCCESSFUL. THERE WERE NO OBSERVED ISSUES WITH THE BATTERY CONNECTION. THE ADAPTER WAS REMOVED FROM SERVICE WITH NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7151935 ↗
• MalfunctionDec 20, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTED THE AC POWER ADAPTER AND EXPERIENCED FAILURE TO POWER THE CONTROLLER. THIS HAPPENED DURING CLINIC VISIT TO HOSPITAL. THE TEAM TRIED TO TROUBLESHOOT AND WERE UNABLE TO RESOLVE. THE 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 7135970 ↗
• MalfunctionDec 20, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER WOULD CONTINUE TO BE POWERED BY THE BATTERY WHEN THE CONTROLLER AC ADAPTOR WAS CONNECTED. THE CONTROLLER AC ADAPTOR 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 7134408 ↗
• MalfunctionDec 14, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT PLUGS OF THE CONTROLLER AC ADAPTER KEPT DISCONNECTING AND WAS LOOSE WHEN PLUGGED IN. THE CONTROLLER AC 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 7117976 ↗
• MalfunctionDec 13, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER CORD WAS FRAYED. THE CONTROLLER AC 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 7113477 ↗
• MalfunctionDec 13, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER WAS SHORTING OUT, INDICATING A POWER DISCONNECT. THE CONTROLLER AC 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 7112569 ↗
• MalfunctionDec 11, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER WAS EXHIBITING INTERMITTENT POWER LOSS. THE CONTROLLER AC 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 7106636 ↗
• MalfunctionDec 4, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER WAS NO LONGER PROVIDING POWER TO A CONTROLLER. THE CONTROLLER AC 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 7080710 ↗
• MalfunctionDec 4, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT TWO CONTROLLER AC ADAPTERS WOULD NOT STAY CONNECTED TO THE CONTROLLER. THE CONTROLLER AC ADAPTERS WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7080678 ↗
• MalfunctionDec 4, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE GREEN LIGHT EMITTING DIODE (LED) LIGHT WAS ON, BUT 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 Known Impact Or Consequence To Patient

  MAUDE report 7080600 ↗
• MalfunctionDec 4, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONNECTOR OF THE CONTROLLER AC ADAPTER WAS LOOSE. THE CONTROLLER AC 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 7080534 ↗
• MalfunctionOct 12, 2017Connection Problem; Connection Problem

  IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2015, THE PATIENT MENTIONED THAT THEIR AC ADAPTER WAS NOT MAKING A SECURE CONNECTION WITH THE CONTROLLER AND THAT IT WOULD DISCONNECT EASILY. THE AC ADAPTER WAS EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946498 ↗
• MalfunctionOct 12, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD AN AC ADAPTER THAT WAS NOT SUPPLYING POWER TO THEIR CONTROLLER WHEN CONNECTED TO THE POWER PORT ON THE CONTROLLER. WHEN CONNECTED TO THE WALL PLUG, THE GREEN LIGHT WAS LIT ON THE POWER BOX BUT THE CONTROLLER DISPLAYED A MESSAGE OF "POWER DISCONNECT, CONNECT POWER". THE AC ADAPTER WAS INSPECTED AND NO DAMAGED WAS NOTED. THE DEVICE HAD NOT BEEN DROPPED AND IT IS UNKNOWN IF THERE WAS AN AUDIBLE CLICK HEARD WITH CONNECTED TO THE CONTROLLER. THE AC ADAPTER WAS REPLACED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946494 ↗
• MalfunctionOct 5, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT HIS AC ADAPTER WOULD NOT STAY CONNECTED TO HIS CONTROLLER. THE VAD COORDINATOR CONFIRMED THE INCIDENT. THERE WERE NO REPORTED CONSEQUENCES ASSOCIATED WITH THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6915164 ↗
• MalfunctionOct 3, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER AC ADAPTER WAS INOPERABLE DUE TO A DAMAGED CONNECTOR. THE PATIENT DID NOT REPORT HOW THE DAMAGE OCCURRED. THE VAD COORDINATOR STATED: "HE JUST BROUGHT THE ADAPTER BACK TO US AND THE PIECE NEAREST CONTROLLER CONNECTER IS WRAPPED IN TAPE". THE DEFECTIVE DEVICE WAS EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6911713 ↗
• MalfunctionSep 28, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT WHILE AT A CLINIC VISIT, THE PATIENT REPORTED THAT THE AC ADAPTER, (B)(4), STOPPED WORKING. THE VAD COORDINATOR CHECKED ALL CABLE CONNECTIONS ON ADAPTER AND FOUND THEM TO BE SECURE. THE COORDINATOR PLUGGED IN THE AC ADAPTER TO THE OUTLET IN CLINIC AND WAS ABLE TO CONFIRM THAT THE ADAPTER WAS NOT DELIVERING POWER TO THE CONTROLLER WHILE CONNECTED. THE COORDINATOR DID NOTE THAT THE AC ADAPTER CORD AT THE CONNECTOR FOR THE CONTROLLER WAS SHARPLY BENT AT A 90 DEGREE ANGLE JUST PROXIMAL TO ITS STRAIN RELIEF AND QUESTIONS IF THERE WAS INTERNAL DAMAGE TO THE WIRING AT THAT POINT. THE CONTROLLER AC 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 6902920 ↗
• MalfunctionSep 27, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENTS CONTROLLER AC ADAPTER WAS NOT PROVIDING POWER TO THE CONTROLLER. PER THE SITE, THE POWER CORD CONNECTION TO THE JUNCTION BOX SEEMS TO BE THE ISSUE. THERE WAS NO PHYSICAL DAMAGE OR FORCE THAT WAS USED ON THE ADAPTER. THE CONTROLLER AC ADAPTER WAS REPLACED WITH CONTROLLER AC ADAPTER (B)(4). 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 6899614 ↗
• MalfunctionSep 27, 2017Power Problem; Power Problem

  IT WAS REPORTED BY THE VAD EQUIPMENT MANAGER THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2016 AND REPORTED THAT CAC- ADAPTER WAS ONLY SUPPLYING INTERMITTENT POWER. HE REPORTED THAT THE ADAPTER WAS SECURELY CONNECTED TO CONTROLLER AND WALL OUTLET, BUT THAT IT WOULD INTERMITTENTLY SWITCH TO BATTERY POWER WHEN CONNECTED. THE CAC WAS REPLACED AND TAKEN OUT OF SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899612 ↗
• MalfunctionSep 20, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE AC ADAPTER DID NOT POWER THE CONTROLLER.  A DIFFERENT ADAPTER WAS ATTEMPTED AND THAT HAD POWER.  THE CONTROLLER AC ADAPTER WAS EXCHANGED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6879563 ↗
• MalfunctionSep 15, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER ALTERNATING CURRENT (CAC) ADAPTER WOULD NOT PROVIDE POWER TO THE CONTROLLER EVEN THOUGH THE LIGHT ON THE JUNCTION BOX WAS GREEN. IT WAS NOTED THAT THERE WAS NO KNOWN DAMAGED TO THE ADAPTER. THE CAC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868726 ↗
• MalfunctionAug 25, 2017Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED BY THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR THAT THE CONTROLLER ALTERNATING CURRENT (CAC) ADAPTER HAD EXPOSED WIRES. THE CAC ADAPTER WAS REMOVED FROM SERVICE AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6820404 ↗
• MalfunctionAug 24, 2017Power Problem; Power Problem

  A PATIENT REPORTED THAT HIS/HER CAC ADAPTER WAS ALARMING AND BEEPING AT NIGHT AND INTERMITTENTLY SHUTTING OFF. THIS WAS ASSOCIATED WITH NO REPORTED PATIENT ISSUE OR INJURY. THE PATIENT IS NOTED TO NEED A NEW CAC ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819019 ↗