HeartWare® Controller AC Adapter 1430US (UDI 00888707009218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888707009218), received between Sep 26, 2022 and Jan 30, 2025 — classified as 20 malfunctions.

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

60 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, 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 ↗
• MalfunctionJan 5, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT CONTROLLER AC ADAPTER DID NOT PROVIDE POWER AND WAS NOT RECOGNIZED BY THE CONTROLLER. THE PATIENT STATED THAT THE CONTROLLER AC ADAPTER WAS NOT REGISTERING TO THE CONTROLLER WHEN CONNECTED. PATIENT ALSO MENTIONED THAT WHEN THE ADAPTER WAS PLUGGED INTO THE WALL, THE GREEN LIGHT DID NOT APPEAR. THE PATIENT ATTEMPTED TO TROUBLESHOOT THE WALL POWER BY UNSCREWING THE CORD, REMOVING IT FROM THE ADAPTER, RECONNECTING IT AND PLUGGING IT BACK INTO WALL, HOWEVER, THE GREEN LIGHT DID NOT SHOW. THE CONTROLLER AC 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 16104423 ↗
• MalfunctionJan 4, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER DID NOT PROVIDE POWER. THE GREEN LIGHT WAS LIT ON THE ADAPTER BUT IT DID NOT PROVIDE POWER TO CONTROLLERS WHEN CONNECTED. THE CONTROLLER AC 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 16098476 ↗
• MalfunctionNov 14, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER DID NOT PROVIDE POWER. THE CONTROLLER AC ADAPTER "WAS ABLE TO RECEIVE POWER BUT THE CONTROLLER WAS UNABLE TO RECOGNIZE IT WAS RECEIVING AC POWER". THE GREEN LIGHT WOULD TURN ON WHEN PLUGGED IN AND IT WAS BELIEVED IT WOULD PLUG IN TO THE CONTROLLER FINE, BUT THE CONTROLLER WOULDN¿T RECOGNIZE THE ADAPTER BEING CONNECTED. A SECOND CONTROLLER AC ADAPTER WAS CONNECTED, AND IT WORKED APPROPRIATELY. 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 15789125 ↗
• MalfunctionSep 26, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER GREEN POWER INDICATOR LIGHT WAS NOT ILLUMINATED. THE CONTROLLER AC 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 15484492 ↗
• MalfunctionSep 26, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER POWER INDICATOR LIGHT WAS NOT ILLUMINATING AND THE CONTROLLER AC ADAPTER WAS NOT RECOGNIZED BY THE CONTROLLER WHEN CONNECTED. THE CONTROLLER AC 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 15484458 ↗

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-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-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• 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-2194-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Implant Kit, REF 1104JP

…and 45 more.