HeartWare® Controller AC Adapter 1430US (UDI 00888707000307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888707000307), received between Dec 20, 2017 and Oct 12, 2018 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Power Problem” (8 reports).

3 FDA recall records name this device's identifier, 3 still open.

57 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 ↗

2. 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 ↗

3. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) AC ADAPTER WAS NOT PROVING POWER TO THE CONTROLLER. THE ADAPTER WAS EXPECTED TO 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 7962631 ↗
• MalfunctionAug 22, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER ALARMS THAT THERE IS NO POWER WHEN CONNECTED TO AC ADAPTER. 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 7806781 ↗
• MalfunctionJun 29, 2018Material Integrity Problem; Material Integrity Problem

  THE BATTERIES WERE RETURNED TO THE MANUFACTURER BECAUSE THEY WERE NOT CHARGING AND THE INDICATOR ON THE BATTERY CHARGER DISPLAYED A FLASHING RED LIGHT. THE DEVICES SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651474 ↗
• MalfunctionJun 25, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER AC ADAPTER DOES NOT PROVIDE POWER. 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 7635234 ↗
• MalfunctionJun 5, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER DID NOT PROVIDE POWER AND THE GREEN LIGHT DID NOT ILLUMINATE. THE CONTROLLER AC 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 7570537 ↗
• MalfunctionMay 15, 2018Power Problem; Power Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7515803 ↗
• MalfunctionApr 30, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT WHEN PLUGGING THE CONTROLLER AC ADAPTER IN THE WALL, THE INDICATOR LIGHT DOES NOT TURN GREEN INDICATING THAT POWER IS REACHING THE AC ADAPTER. THE AC ADAPTER DOES NOT PROVIDE POWER. THE 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 7474442 ↗
• MalfunctionApr 19, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER DID NOT LOCK CORRECTLY ON THE CONTROLLER POWER PORT AND EASILY BECAME DISCONNECTED, WITH NO REPORTED DAMAGE TO THE CABLE OR CONTROLLERS. 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 7443211 ↗
• MalfunctionMar 26, 2018Device Inoperable; Power Problem; Device Inoperable; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER AC ADAPTER DID NOT PROVIDE POWER. 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 7371251 ↗
• MalfunctionDec 20, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT A PATIENT¿S CONTROLLER AC ADAPTER DID NOT PROVIDE POWER TO THE CONTROLLER AFTER HAVING BEEN DROPPED. THE EVENT WAS NOT ASSOCIATED WITH ANY CONTROLLER ALARMS OR PUMP STOP EVENTS. THE EVENT DID NOT REQUIRE MEDICAL INTERVENTION. THE CONTROLLER AC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2018 IT WAS REPORTED THAT A PATIENT¿S CONTROLLER AC ADAPTER DID NOT PROVIDE POWER TO THE CONTROLLER AFTER HAVING BEEN DROPPED. THE EVENT WAS NOT ASSOCIATED WITH ANY CONTROLLER ALARMS OR PUMP STOP EVENTS. 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 7133294 ↗

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-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-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-2193-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Driveline Extension Cable, REF 100US

…and 42 more.