Sterling® SL H74939148201210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729782223), received between Mar 19, 2019 and Apr 7, 2025 — 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 16, 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.

• MalfunctionApr 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY OF THE LOWER EXTREMITY. A 2.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR BILATERAL PUNCTURE OF THE LOWER EXTREMITY PROCEDURE. HOWEVER, THE BALLOON BURST DURING SECOND INFLATION AT 20 ATMOSPHERES FOR 2 MINUTES. THE DEVICE WAS REMOVED NORMALLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITIONS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21787399 ↗
• MalfunctionJul 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE PERIPHERAL ARTERY. A 2.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT BELOW 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19874855 ↗
• MalfunctionFeb 17, 2023Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  MID 60¿S MALE 3 DAY POST OP FROM RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) REVASCULARIZATION AND STENTING. DECREASED CIRCULATION IN THE RIGHT LOWER EXTREMITY AND WAS TAKEN FOR PROCEDURE: RIGHT LOWER EXTREMITY (RLE) ANGIOGRAM, MECHANICAL THROMBECTOMY/PLASTY. THEN END OF THE BALLOON WAS PATENT AND FLUSHED WELL BUT THE END OF THE BALLOON WOULD BUNCH UP AND NOT LET THE WIRE GO THROUGH. THE DEVICE WAS NOT USED ON THE PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, STERLING® SL (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16396100 ↗
• MalfunctionJun 14, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST BEFORE REACHING THE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687860 ↗
• MalfunctionDec 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11004210 ↗
• MalfunctionMar 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A ROTALINK WAS TESTED OUTSIDE OF THE BODY AND IT WAS WORKING CORRECTLY. THE PLAQUE WAS ENGAGED WITH A ROTABLATOR, BUT IT WAS NO LONGER SPINNING INSIDE OF THE BODY. THE ROTABLATOR WAS REMOVED AND A 2.0MM X 120MM X 150CM STERLING SL BALLOON CATHETER WAS THEN ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED BEFORE IT GOT TO THE NOMINAL SIZE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434246 ↗