Sterling® SL H74939148258010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729782285), received between May 14, 2020 and May 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN NON-SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY BELOW THE KNEE. PRE-DILATION WAS PERFORMED WITH A 2.0MM STERLING BALLOON. A 2.5MMX80MMX150CM STERLING SL BALLOON AND V18 GUIDEWIRE WERE SELECTED WERE SELECTED FOR USE. THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES. A 2.5MMX120MMX150CM STERLING SL BALLOON WAS SELECTED TO CONTINUE THE CASE. THE 2.5MMX120MMX150CM STERLING SL BALLOON CATHETER BECAME STUCK ON THE V18 GUIDEWIRE AND COULD NOT BE PUSHED FORWARD. BOTH BALLOON CATHETER AND GUIDE WIRE WERE THEN REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STERLING SL BALLOON AND V18 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10058080 ↗