Sterling™ H74939032202290Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729859987), received between May 11, 2023 and May 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Deflate” (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
- Failure to Deflate1
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.
MalfunctionMay 11, 2023Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA PEDAL APPROACH. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 2.0X220X90 STERLING BALLOON CATHETER WAS ADVANCED AND WAS INFLATED AT NOMINAL PRESSURE. HOWEVER, WHEN THE INFLATOR WAS RELEASED, THE BALLOON FAILED TO DEFLATE. THE INFLATOR WAS REMOVED AND PUT ON A NON-BOSTON SCIENTIFIC INFLATION DEVICE AND DID SEVERAL NEGATIVE PULLS TO GET THE SALINE OR CONTRAST REMOVED. IT TOOK 5 TO 10 MINUTES BEFORE IT DEFLATED ENOUGH. EVENTUALLY, THE BALLOON DEFLATED AND WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0X220X90 STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16914337 ↗
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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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