Sterling™ H74939032508080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729122968), received between Jul 24, 2019 and Jul 24, 2019 — 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 16, 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.

• MalfunctionJul 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 5.00 MM X 80 MM X 80 CM STERLING BALLOON WAS USED TO DILATE THE TARGET LESION, AND ON INFLATION AT 4 TO 6 ATMOSPHERES, THE BALLOON RUPTURED. IT WAS NOTED THAT THE BALLOON RUPTURE WAS DUE TO THE SEVERELY CALCIFIED LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822513 ↗