Sterling® SL H74939147351210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729782728), received between Jan 31, 2022 and Mar 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER MEDWATCH MW5107106 THAT THE BALLOON DETACHED. A 3.5MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE INTO TWO PIECES. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862907 ↗
• MalfunctionJan 31, 2022Break

  WHILE ATTEMPTING TO USE A STERLING SL MONORAIL 4F PTA BALLOON DILATATION CATHETER, THE PRODUCT DEFAULTED AND THE BALLOON WOULD NOT RELEASE. THE PRODUCT BROKE INTO 2 PIECES. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13417474 ↗