Sterling™ H74939032706010Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Sterling (153)
Data updated Oct 16, 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 08714729124115), received between Feb 18, 2025 and Feb 18, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Rupture1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT BALLOON RUPTURE/DETACHMENT AND ADDITIONAL INTERVENTION WAS PERFORMED. A 7.0MMX60MMX135CM STERLING WAS USED FOR DILATION. DURING PROCEDURE, THE BALLOON POPPED, LEAVING A PIECE LODGED IN THE RIGHT LOWER LEG ARTERY. THE SURGEON USED A SNARE TO RETRIEVE THE BROKEN PART, CONFIRMED IT WAS COMPLETE, AND VERIFIED NO OTHER FOREIGN BODIES REMAINED, AS SEEN ON THE C-ARM. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: Vascular Dissection
MAUDE report 21405665 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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