Sterling™ H74939032302290Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729860181), received between Jun 4, 2020 and Jul 21, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BURST, REQUIRING ADDITIONAL INTERVENTION. DURING AN ANGIOGRAM AND ANGIOPLASTY OF THE LEG, A 3.0X220X90 MM STERLING BALLOON CATHETER WAS INFLATED ONCE. THE BALLOON BURST AT A PRESSURE BELOW THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT, HOWEVER, IT WAS NOT INITIALLY RECOGNIZED THAT A PORTION OF THE BALLOON HAD SEPARATED AND REMAINED IN THE PATIENT. A CONTRAST ANGIOGRAM IDENTIFIED THE BALLOON FRAGMENT IN THE LOWER LEG. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A SNARE, AND ANOTHER STERLING BALLOON CATHETER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED, THE PATIENT WAS STABLE AND WAS DISCHARGED, AND FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25898383 ↗
• MalfunctionJul 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0X220X90 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT 80% STENOSED TARGET LESION WAS LOCATED IN THE MILD CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE BALLOON RUPTURE UPON INFLATION AT NOMINAL PRESSURE. THE DEVICE WAS REMOVED AND THE PATIENT WAS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818315 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS BEING TREATED FOR LOWER LIMB VESSEL OCCLUSION AND UNDERWENT ANGIOPLASTY. A 3.0X220X90 (4F) STERLING BALLOON CATHETER WAS USED FOR DILATATION. THE DEVICE WAS WITHDRAWN WITH NO RESISTANCE. HOWEVER, UPON REMOVAL, THE SHAFT BROKE OFF COMPLETELY AROUND THE SHEATH AREA OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318776 ↗
• MalfunctionApr 22, 2022Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0X220X90 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT 6 ATMOSPHERES FOR 1 MINUTE; HOWEVER, THE BALLOON WOULD NOT DEFLATE. TRIED DOUBLE NEGATIVE WITH THE 3WAY AND A 30CC ATTACHED AS WELL. TRIED A STIFFER WIRE AND EVENTUALLY, WAS ABLE TO MOVE THE BALLOON ENOUGH TO DEFLATE SOME. THE DEVICE WAS REMOVED PARTIALLY INFLATED FROM THE PATIENT AND A KINK WAS NOTICED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187111 ↗
• MalfunctionJun 4, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 3.0 X 220 X 90 (4F) STERLING BALLOON WAS SELECTED FOR USE. DURING REMOVAL, THE GUIDE BROKE MAKING THE REMOVAL OF THE BALLOON IMPOSSIBLE. THE HOSPITALIZATION TOOK LONGER AS THE PATIENT WAS GIVEN LOCAL ANESTHESIA AND ADDITIONAL SURGICAL INTERVENTION WAS REFORMED TO REMOVE THE GUIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121090 ↗