Sterling™ H74939032350410Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Sterling (153)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729860235), received between Jul 1, 2020 and Jul 1, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS AN AREA OF INSTANT RESTENOSIS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 3.5X40X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON DEFLATION OF BALLOON, PART OF THE BALLOON CAME OFF. SUBSEQUENTLY, THE PIECE OF THE BALLOON WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Code Available
MAUDE report 10218302 ↗
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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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