Sterling™ H74939032806080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729720713), received between Sep 23, 2019 and Sep 23, 2019 — 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 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.

• InjurySep 23, 2019Material Rupture; Detachment of Device or Device Component; Material Integrity Problem; Material Rupture; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP DETACHED. AN 8.0MMX60MMX80CM STERLING BALLOON WAS SELECTED FOR A SHUNT PROCEDURE IN THE UPPER LEG. DURING THE PROCEDURE, THE BALLOON WAS DAMAGED DURING DILATATION AND THE TIP OF THE DEVICE DETACHED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT WHEN DILATING THE BALLOON, IT SUDDENLY BURST. THE BALLOON PRESSURE WAS 13 MILLIBARS WHEN IT BURST. RADIOGRAPH SHOWED THAT A TORN PART OF THE BALLOON REMAINED IN THE VESSEL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED PIECE OF THE BALLOON WITH A SNARE CATHETER. AFTER REMOVING THE BALLOON, IT WAS NOTED THAT THE BALLOON HAD BEEN TORN CIRCULARLY 5MM IN FRONT OF THE TIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9105401 ↗