Sterling® SL H74939148351510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729782353), received between Dec 18, 2018 and Jan 14, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionJan 14, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON PERFORATED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.5MM X 150MM X 150CM STERLING SL WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, A PRESSURE DROP WAS OBSERVED DURING THE INITIAL INFLATION, WHICH WAS MAINTAINED FOR APPROXIMATELY 30 SECONDS. THE BALLOON HEAD WAS SUBSEQUENTLY FOUND TO BE PERFORATED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE POST PROCEDURE AND THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069941 ↗
• MalfunctionApr 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 3.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 8 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED AND BACKFLOW OF BLOOD WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981567 ↗
• MalfunctionDec 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.5MM X 150MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, UPON INFLATION THE BALLOON RUPTURED. AFTER A MINUTE OF PRESSURE, THE DEVICE WAS REMOVED AND BLOOD CAME BACK IN THE ENDOFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176214 ↗