Sterling® SL H74939148201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729782216), received between Mar 12, 2021 and Dec 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON HAD A PINHOLE. A 2.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON LEAKED AND PINHOLE IN THE MIDDLE OF THE MARKER WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12991189 ↗
• MalfunctionNov 8, 2021Material Puncture/Hole; Difficult to Advance; Material Puncture/Hole; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE PERFORATED THE CATHETER SHAFT. A 2.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 99% STENOSED, SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION WAS LOCATED IN AN ARTERY BELOW THE KNEE (BTK). THERE WAS DIFFICULTY ADVANCING THE BALLOON THROUGH THE LESION. THE BALLOON WAS REMOVED TO EXCHANGE FOR A LOWER PROFILE BALLOON. DURING REMOVAL, THEY OBSERVED THE NON-BOSTON SCIENTIFIC GUIDEWIRE WAS PROTRUDING THROUGH THE SHAFT PROXIMAL TO THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12774873 ↗
• MalfunctionMar 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.0MM X 100MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, PRIOR TO CROSS THE LESION, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND THE PATIENT CONDITION WAS FINE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477548 ↗