Sterling™ H74939032506080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729122944), received between Jun 6, 2019 and Feb 9, 2026 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0MMX60MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 8 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED IN A PINHOLE FORM AT THE CENTER PART. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293607 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0MM X 60MM X 80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS DEFLATED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315853 ↗
• MalfunctionMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0MMX100MMX80CM (4F) STERLING, 4.0 X 100, 75CM MUSTANG, 5.0MMX60MMX80CM (4F) STERLING, 6.0 X 200, 75CM MUSTANG, AND A 6.0 X 100, 75CM MUSTANG BALLOON CATHETERS WERE ADVANCED RESPECTIVELY FOR DILATION. HOWEVER, ON THE FIRST INFLATION, THE BALLOONS RUPTURED. THE DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496441 ↗
• InjuryJun 6, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE STRAIGHT, DIFFUSED SUPERFICIAL FEMORAL ARTERY. AFTER A V18 GUIDE WIRE AND TWO NON-BSC GUIDE WIRES CROSSED THE LESION, A 5.0MMX60MMX80CM (4F) STERLING BALLOON CATHETERS WAS ADVANCED FOR PRE-DILATATION. THE BALLOON WAS INFLATED AT 8 ATMOSPHERES. HOWEVER, AFTER INFLATION, THE PHYSICIAN WAS NOT ABLE TO DEFLATE THE BALLOON. THE BALLOON WAS WITHDRAWN IN INFLATED STATE TO THE F5 11CM NON-BSC GUIDE SHEATH. THE PHYSICIAN THEN USED A BIOPSY NEEDLE TO PUNCTURE AND REMOVE THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674276 ↗