Sterling™ H74939032702110Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729845553), received between Nov 24, 2023 and Aug 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
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
- Material Rupture2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem
IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 7.0X200X150 CM STERLING CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON DID NOT FUNCTION CORRECTLY. UPON REMOVAL FROM THE PATIENT, A MELTED DIVOT WAS OBSERVED IN THE BALLOON. IT WAS POPPED OPEN OUTSIDE THE PATIENT, BUT THE DIVOT REMAINED. THE BALLOON WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742369 ↗MalfunctionNov 24, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON PRESENTED WITH A HOLE. A 7.0X200X150 STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, A HOLE IN THE BALLOON MATERIAL WAS NOTED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18206476 ↗
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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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