Sterling™ H74939032602090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729845461), received between Jun 19, 2020 and May 15, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X200X90 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURSTED BEFORE IT WAS INFLATED TO RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031520 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X200X90-HYBRID STERLING OTW BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE IT WAS INFLATED TO RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED. THE BALLOON RUPTURED DURING FIRST INFLATION, AND IT REMOVED FROM THE PATIENT CAREFULLY AND SLOWLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731100 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS SHUNT IN THE MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 6.0X200X90-HYBRID STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST BEFORE REACHING NORMAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528271 ↗
• InjuryJun 19, 2020Material Rupture; Detachment of Device or Device Component; Difficult to Advance; Material Twisted/Bent; Material Rupture; Detachment of Device or Device Component; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT MULTIPLE ISSUES HAD OCCURRED IN THE DURATION OF A PROCEDURE. A PROCEDURE WAS BEING PERFORMED, 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS PROXIMAL AREA OF THE RIGHT SUPERIOR FEMORAL ARTERY. A 6 X 200 X 90 HYBRID STERLING BALLOON CATHETER WAS BEING USED. THE PHYSICIAN HAD FELT SOME RESISTANCE DURING INSERTION OF THE BALLOON, BUT IT WAS NOTED THAT THERE WAS A LOT OF CALCIFICATION. THE BALLOON WAS ABLE TO BE ADVANCED TO THE TARGETED SITE. THE PHYSICIAN INFLATED THE BALLOON AT NOMINAL PRESSURE AND WAS DESCRIBED AS NOT BEING WELL DEPLOYED. THE PRESSURE WAS INCREASED TO ABOUT TWELVE ATMOSPHERES, AT WHICH POINT IT WAS SAID TO BE WELL DEPLOYED BUT THAT THERE WAS A "HICCUP" IN THE PROXIMAL AREA. AT THAT POINT, THE PHYSICIAN BELIEVES THAT THE BALLOON RUPTURED AND BROKE. AFTER THE DILATATION, THE BALLOON WAS REMOVED. ONCE IT WAS OUTSIDE THE PATIENT THEY SAW THAT A PART OF THE BALLOON WAS MISSING. IT WAS ATTEMPTED TO REMOVE THE PART FROM THE PATIENT BY SNARING, BUT THIS FAILED. THE PHYSICIAN STATED THAT THE PATIENT WAS OKAY IMMEDIATELY AFTER THE PROCEDURE. NO PAIN OR COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PHY

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10174529 ↗