Permanent Sled Bag H749393150100Recalls & reported problems
Boston Scientific Corporation · Sterile bag for MDU5 PLUS Motordrive · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729896845), received between Mar 25, 2025 and Aug 19, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Delivered as Unsterile Product1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326245 ↗MalfunctionMar 3, 2026Contamination
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. THE PERMANENT SLED STERILE BAG, A SYSTEM ACCESSORY WHICH WAS PART OF AN ILAB ULTRASOUND IMAGING SYSTEM, WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, WHEN OPENING THE SLED BAG, THE PHYSICIAN OBSERVED THAT THE STICKER WAS NOT INTACT AND CONCERNED ABOUT THE STERILITY WHEN COVERING THE MDU. THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500670 ↗MalfunctionMar 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. FOLLOWING AN ULTRASOUND EXAMINATION INVOLVING AN ILAB IMAGING SYSTEM, IT WAS NOTICED THAT A SMALL AMOUNT OF BLOOD WAS PRESENT ON THE PERMANENT SLED BECAUSE THE PERMANENT SLED STERILE BAG HAD DEVELOPED A HOLE UNDER WHERE THE CATHETER WAS SEATED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692155 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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