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Alarm Adapter 1450Recalls & reported problems

Heartware Inc. · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888707000161), received between Nov 17, 2017 and Apr 23, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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.

Most reported problems

Device problems

  • Connection Problem1
  • Loose or Intermittent Connection1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 23, 2018Connection Problem; Connection Problem

    IT WAS REPORTED THAT THE DRIVELINE CABLE WAS UNABLE TO PROPERLY CONNECT TO THE CONTROLLER. THE CONTROLLER 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 7452080 ↗
  • MalfunctionNov 17, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE CONTROLLER HAD A LOOSE POWER PORT CONNECTION. THE CONTROLLER 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 7041727 ↗

Other Ventricular (Assisst) Bypass devices

All Ventricular (Assisst) Bypass devices →

Sources and updates

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