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NA H749I5033R0Recalls & reported problems

Boston Scientific Corporation · Motordrive Unit (MD5) · Class 2

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729401094), received between Jun 9, 2020 and Jun 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software 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

  • Computer Software Problem1
  • Failure to Power Up1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 9, 2020Computer Software Problem; Failure to Power Up; Computer Software Problem; Failure to Power Up

    IT WAS REPORTED THAT THE SYSTEM IS NOT BOOTING. A CE MOTOR DRIVE WAS SELECTED TO BE USED FOR A PROCEDURE. PRIOR TO THE PROCEDURE, THE SYSTEM WAS NOT BOOTING. THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT AND IT WAS UNKNOWN IF THE PATIENT WAS SEDATED. THE PATIENT WAS STABLE AND NO PATIENT COMPLICATIONS OCCURRED.

    Patient problems: No Patient Involvement

    MAUDE report 10133046 ↗

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Sources and updates

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