Sterling® SL H74939148301090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729782476), received between Nov 18, 2020 and Dec 1, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT POPLITEAL ARTERY VIA CONTRALATERAL APPROACH. A 3.0MM X 100MM X 90CM STERLING SL WAS ADVANCED OVER THE WIRE FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815497 ↗
• MalfunctionDec 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 100MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION UNDER NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012542 ↗
• MalfunctionJul 9, 2021Contamination; Material Integrity Problem; Contamination; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A 3.0MM X 100MM X 90CM STERLING SL BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE BALLOON WAS DAMAGED AND THE REEL APPEARED DIRTY. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144693 ↗
• MalfunctionMar 1, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 100MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER REACHING THE NOMINAL PRESSURE, THE BALLOON PART WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT BALLOON RUPTURE OCCURRED AND NO ADDITIONAL INTERVENTION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396283 ↗
• MalfunctionJan 26, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 3.0MM X 100MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION BELOW THE NOMINAL PRESSURE, THE BALLOON LEAKED. THE DEVICE WAS REMOVED AND A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11229668 ↗
• MalfunctionNov 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0MM X 100MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862658 ↗