Sterling™ H74939032606080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729123811), received between Jan 3, 2024 and Jun 2, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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.

• InjuryJun 2, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON DEFLATION ISSUE OCCURRED. A 6.0MM X 60MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. AFTER STENT PLACEMENT, THE BALLOON WAS USED TO DILATE THE STENT. HOWEVER, THE BALLOON DID NOT DEFLATE AFTER THE SECOND INFLATION. THE BALLOON WAS PULLED UP UNTIL THE SHEATH BUT COULD ONLY BE EXTRACTED AFTER THE PHYSICIAN MADE AN ADDITIONAL PERCUTANEOUS PUNCTURE IN THE INSERTION AREA IN ORDER TO PUNCTURE THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127082 ↗
• MalfunctionJan 5, 2024Entrapment of Device; Material Puncture/Hole; Entrapment of Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON GOT STUCK TO THE GUIDEWIRE AND THERE WAS A SMALL HOLE ON BALLOON SHAFT. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 6.0MMX60MMX80CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN LOADED THE BALLOON ONTO THE GUIDEWIRE, BUT THE BALLOON GOT STUCK TO THE WIRE. THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AND UPON CHECKING, A SMALL HOLE IN THE BALLOON SHAFT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON GOT STUCK TO A 018 300 CM BOSTON SCIENTIFIC PLATINUM PLUS GUIDEWIRE. FURTHERMORE, THE BALLOON AND GUIDEWIRE HAVE TO BE REMOVED AS ONE UNIT, BUT THE GUIDEWIRE WAS NOT ABLE TO BE REMOVED FROM THE BALLOON OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453451 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN IN THE LEFT FOREARM. A 6.0MMX60MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434494 ↗