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Sterling™ H74939031703080Recalls & 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 08714729757436), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1
  • Material Puncture/Hole1

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.

  • MalfunctionJul 1, 2022Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

    IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. A 7.0MMX30MMX80CM (4F) STERLING BALLOON CATHETER WAS PREPARED FOR USE. HOWEVER, PRIOR TO ADVANCING OVER THE GUIDEWIRE, THE PHYSICIAN NOTICED THAT THE SHAFT OF THE BALLOON WAS TORN. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A 7X20 STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14885532 ↗

Other CATHETER, PERCUTANEOUS devices

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Sources and updates

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