HeartWare® Controller AC Adapter 1430US (UDI 00888707002738)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888707002738), received between Apr 20, 2018 and Mar 3, 2021 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Power Problem” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

59 other recalls cover devices cleared under the same FDA submission (P100047); they may or may not involve this specific model.

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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE CAC ADAPTER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406225 ↗
• MalfunctionJan 26, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER MALFUNCTIONED. THE CONTROLLER AC 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 11229494 ↗
• MalfunctionMar 9, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER DID NOT PROVIDE POWER. THE CAC 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 9806746 ↗
• MalfunctionFeb 18, 2020Fitting Problem; Material Deformation; Fitting Problem; Material Deformation

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER HAD A STRIPPED SCREW THAT WAS UNABLE TO BE TIGHTENED ON THE BRACKET CONNECTING THE AC CORD TO THE OUTLET. THE BRACKET WAS REMOVED TO TROUBLESHOOT AND THE EPOXY HOLDING THE SCREW WASHER IN PLACE SPLIT APART. 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 9722415 ↗
• MalfunctionFeb 7, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER DID NOT PROVIDE POWER. THE CAC ADAPTER WAS REMOVED FROM SERVICE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9684732 ↗
• MalfunctionJan 31, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER DID NOT PROVIDE 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 9655944 ↗
• MalfunctionAug 15, 2019Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER WAS NOT PROVIDING POWER. THE CAC 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 8897942 ↗
• MalfunctionJul 12, 2019Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER ALTERNATING CURRENT (CAC) ADAPTER WAS BROKEN. IT WAS STATED THAT THE MOVEABLE SECUREMENT THAT ATTACHES THE CAC ADAPTER TO THE CONTROLLER WAS BROKEN. THE CAC 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 8786650 ↗
• MalfunctionMar 26, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT MULTIPLE AC ADAPTER BRACKETS WERE TO TIGHT TO INSERT THE ELECTRICAL CORD, EVEN AFTER LOOSENING THE SCREW. THE BRACKETS HAD TO BE MECHANICALLY OPENED WIDER BEFORE INSERTING THE CORD THEN TIGHTENING THE SCREW. THE CONTROLLER AC ADAPTERS REMAIN IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8453454 ↗
• MalfunctionMar 26, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE BRACKET ON THE CONTROLLER AC ADAPTERS WAS SO TIGHT THAT IT NEEDED TO BE SPREAD OPEN WITH A CLAMP TO BE ABLE TO FIT THE POWER CORD INTO THE CONTROLLER AC ADAPTER BOX. BOTH CONTROLLER AC ADAPTERS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453446 ↗
• MalfunctionMar 26, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTERS WERE OPENED AND FOUND THAT THE BRACKET THAT HOLDS THE POWER CORD TO THE BOX WAS VERY LOOSE, AS IT WAS NOT SCREWED DOWN TIGHT TO THE BOX. THE BRACKET AND POWER CORD WERE THEN SECURED IN PLACE. THE CONTROLLER AC ADAPTERS REMAIN IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8453431 ↗
• MalfunctionMar 26, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT PRIOR TO USE THERE WAS GREAT DIFFICULTY IN ATTACHING THE CONTROLLER AC ADAPTER CORD TO THE CONTROLLER AC ADAPTER BOX ON SEVERAL PRODUCTS. THE CLAMP HAD TO BE COMPLETELY REMOVED AND REATTACHED IN ORDER TO SECURE THE CONNECTION DUE TO MISALIGNMENT. THE CONTROLLER AC ADAPTERS REMAIN IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8453391 ↗
• MalfunctionFeb 15, 2019Break; Break

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER BROKE WHILE BEING INITIALLY ASSEMBLED. THE HEALTH CARE PROVIDER INDICATED "INSTEAD OF JUST SCREW BREAKING, THE NUT FELL OFF TOO." THE CONTROLLER AC ADAPTER WAS EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8343733 ↗
• MalfunctionJan 8, 2019Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT¿S CONTROLLER AC ADAPTER DOES NOT PROVIDE POWER TO THE CONTROLLER. IT WAS FURTHER REPORTED THAT THE LIGHT AND POWER ON THE AC ADAPTER WAS GOING ON AND OFF. THE CONTROLLER AC 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 8228354 ↗
• MalfunctionOct 5, 2018Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE SECUREMENT SCREW ON THE CONTROLLER AC ADAPTER BROKE WHILE TIGHTENING THE SCREW. 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 7939912 ↗
• MalfunctionSep 14, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER AND THREE BATTERIES HAD DAMAGED CABLES WITH EXPOSED WIRES. THE BATTERY CABLES HAD CRACKED OUTER SHEATHS. THE CONTROLLER AC ADAPTER AND THREE BATTERIES 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 7878339 ↗
• MalfunctionSep 11, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT MULTIPLE CONTROLLER AC ADAPTORS WOULD NOT PROVIDE POWER WHEN CONNECTED TO THE CONTROLLER. THE MULTIPLE ADAPTORS 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 7866388 ↗
• MalfunctionAug 1, 2018Power Problem; Appropriate Device Problem Term/Code Not Available; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER AC ADAPTER MALFUNCTIONED. 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 7740337 ↗
• MalfunctionJul 10, 2018Loss of Power; Power Problem; Power Problem

  IT WAS REPORTED THAT THERE WERE TWO CONTROLLER AC ADAPTERS THAT DID NOT PROVIDE POWER. BOTH 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 7674947 ↗
• MalfunctionJun 20, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO THE CONTROLLER AC ADAPTER OVERNIGHT AND HAD A POWER DISCONNECT ALARM. THE CONTROLLER AC LIGHT ON THE CONTROLLER WAS OFF EVEN THOUGH THE AC ADAPTER WAS STILL CONNECTED TO THE WALL AND THE CONTROLLER. THE CORDS WERE REPOSITIONED WITH RETURN OF POWER AND THE PATIENT¿S VENTRICULAR ASSIST DEVICE (VAD) WAS CHANGED TO BATTERIES WITHOUT ISSUE. 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 7621512 ↗
• MalfunctionJun 11, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER HAD POOR MECHANICAL CONNECTION AND WAS NOT LOCKING APPROPRIATELY ONTO THE POWER PORTS ON THE CONTROLLER. THERE WAS NO DAMAGE NOTED. THE CONTROLLER AC ADAPTER HAD LOW PRIORITY POWER DISCONNECT ALARMS. THE PATIENT WAS NOTED TO BE CLINICALLY STABLE. 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 7588709 ↗
• MalfunctionJun 5, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER AC ADAPTOR EXHIBITED A DAMAGED CABLE. THE AC ADAPTOR 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 7571043 ↗
• MalfunctionMay 30, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER DID NOT PROVIDE POWER. THE CONTROLLER AC ADAPTER WAS TAKEN OUT OF SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554808 ↗
• MalfunctionApr 23, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT POST-OPERATIVE, THE CONTROLLER AC (CAC) ADAPTER DID NOT PROVIDE POWER. THE CAC ADAPTER WAS CONNECTED TO THE CONTROLLER, BUT NO GREEN LIGHT WAS SEEN. CONNECTIONS WERE CHECKED AND A DIFFERENT OUTLET WAS TRIED, BUT NO POWER WAS SUPPLIED BY THE CAC ADAPTER. THE CAC 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 7453003 ↗
• MalfunctionApr 20, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) AC ADAPTOR WOULD NOT PROVIDE POWER. THE AC ADAPTOR 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 7446803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100047. One submission often covers many models, so check the product and lot details in each record.

• Z-0475-2024 · Oct 31, 2023 · Open, Classified
  HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
• Z-1993-2023 · May 16, 2023 · Open, Classified
  HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
• Z-1512-2022 · Jun 28, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
• Z-1266-2022 · May 5, 2022 · Open, Classified
  HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
• Z-1207-2022 · Apr 14, 2022 · Open, Classified
  HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
• Z-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• Z-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• Z-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1107-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) H
• Z-1110-2022 · Mar 30, 2022 · Open, Classified
  Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump
• Z-0726-2022 · Jan 27, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System
• Z-2478-2021 · Aug 6, 2021 · Open, Classified
  Medtronic HVAD Pump Implant Kits
• Z-2191-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1153

…and 44 more.