Sterling® SL H74939147308010Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Sterling SL (35)
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 08714729782704), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Material Rupture1
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.
MalfunctionFeb 17, 2023Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE DUE TO PERFORATION. A STERLING SL BALLOON WAS SELECTED FOR USE TO PRE-DILATE INTRASTENT STENOSIS OF THE SUPERIOR MESENTERIC ARTERY. ONCE THE STERLING WAS POSITIONED WITHIN THE TARGET LESION, IT FAILED TO INFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS DETERMINED THAT THE BALLOON WAS PERFORATED. THE BALLOON WAS REPLACED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16400072 ↗
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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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