Sterling® SL H74939148201590Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729782414), received between Sep 12, 2018 and Jan 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

• MalfunctionJan 5, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE PACKAGING. A 2.0MM X 150MM X 90CM STERLING SL BALLOON WAS SELECTED FOR A PROCEDURE IN THE RIGHT LEG ARTERY. UPON UNPACKING, A HAIR WAS FOUND INSIDE THE STERILE BAG. A DIFFERENT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11117737 ↗
• MalfunctionSep 12, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING ADVANCING, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. BOTH BALLOON CATHETER AND GUIDE WIRE WERE THEN REMOVED SIMULTANEOUSLY FROM THE PATIENT'S BODY. THE PROCEDURE WAS DISCONTINUED DUE TO ANOTHER REASON. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7870582 ↗