Sterling® SL H74939148351010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729782339), received between May 11, 2022 and May 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryMay 11, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE TARGET LESION WAS HIGHLY STENOSED, SEVERELY CALCIFIED AND MODERATELY TORTUOUS. A STERLING BALLOON WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE TRUNCUS TIBIOFIBULARIS. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE DURING THE FIRST INFLATION FOR ONE MINUTE. HOWEVER, THE BALLOON RUPTURED AND THEN DETACHED. WITH THE HELP OF SUPPORT CATHETERS, THE PHYSICIAN WAS ABLE TO REMOVE THE PARTS OF THE BALLOON. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED USING A NEW STERLING BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14355309 ↗