MDU5 PLUS Sterile Bag H749MDU5PLUSBAG0Recalls & reported problems
Boston Scientific Corporation · Sterile bag for MDU5 PLUS Motordrive · Class 2
Data updated Oct 18, 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 08714729842255), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Delivered as Unsterile Product; Material Puncture/Hole; Delivered as Unsterile Product; Material Puncture/Hole
IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED. AN MDU PLUS STERILE BAG WAS USED AS PART OF THE ILAB ULTRASOUND IMAGING SYSTEM FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CONNECT THE IVUS CATHETER TO THE MOTORDRIVE UNIT (MDU), BUT IT KEPT DISCONNECTING. THE SCREEN DISPLAYED AN ERROR, AND THE PHYSICIAN COULD NOT COMPLETE THE RUN. AS A RESULT, THE MDU PLUS STERILE BAG BECAME UNSTERILE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621942 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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