Sterling™ H74939032300290Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729860105), received between Sep 11, 2018 and Feb 19, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK ON THE WIRE. A STERLING OVER-THE-WIRE, 3.0MM X 20MM 90CM 4 FRENCH (4F) BALLOON ALONG WITH A V-18, 150CM, 8CM POLY TIP GUIDEWIRE WERE SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PROCEDURE, THE WIRE WAS POSITIONED IN THE PATIENT AND THE BALLOON WAS PASSED OVER THE WIRE WITH NO PROBLEM AND THE BALLOON SUCCESSFULLY INFLATED. UPON REMOVAL ATTEMPTS, WHEN THE PHYSICIAN ATTEMPTED TO SLIDE THE BALLOON BACK ALONG THE WIRE IT WOULD NOT MOVE AND WAS STUCK ON THE WIRE. THE WIRE AND BALLOON WERE REMOVED FROM THE PATIENT TOGETHER. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729416 ↗
• MalfunctionSep 11, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION OCCURRED. A 3.0 X 20 X 90 (4F) STERLING WAS ADVANCED TO THE TARGET LESION. WHILE TRYING TO REMOVE THE DEVICE, THE BALLOON HAD AN EXTREMELY LONG DEFLATION TIME. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866411 ↗