Sterling™ H74939032300610Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729860150), received between Feb 15, 2023 and Feb 5, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 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.

• MalfunctionFeb 5, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0X60X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INFLATION, THE BALLOON RUPTURED WITHOUT REACHING THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267499 ↗
• MalfunctionMar 21, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON FEBRUARY 26, 2025. IT WAS REPORTED THAT THE DEVICE FAILED TO INFLATE DURING THE PROCEDURE. THE TARGET LESION, WHICH WAS 50% STENOSED, WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE KNEE. A 3.0 X 60 X 150 MM STERLING BALLOON CATHETER WAS ADVANCED TO THE SITE FOR DILATION. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE PRESSURE CONTINUOUSLY DROPPED, AND THE BALLOON DID NOT INFLATE AS EXPECTED. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND FURTHER ATTEMPTS TO INFLATE THE BALLOON OUTSIDE THE BODY CONFIRMED THE PRESENCE OF A LEAK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED THE PRESENCE OF A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665701 ↗
• MalfunctionMar 21, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON FEBRUARY 26, 2025. IT WAS REPORTED THAT THE DEVICE FAILED TO INFLATE. THE TARGET LESION, WHICH WAS 50% STENOSED, WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE KNEE. A 3.0 X 60 X 150 MM STERLING BALLOON CATHETER WAS ADVANCED TO THE SITE FOR DILATION. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE PRESSURE CONTINUOUSLY DROPPED, AND THE BALLOON DID NOT INFLATE AS EXPECTED. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND FURTHER ATTEMPTS TO INFLATE THE BALLOON OUTSIDE THE BODY CONFIRMED THE PRESENCE OF A LEAK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED THE PRESENCE OF A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665699 ↗
• MalfunctionSep 23, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE COMPLETE TOTAL OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 3.0X60X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN INFLATED WITH INDEFLATOR, THE BALLOON NEVER INFLATED AND THE CONTRAST JUST WENT THROUGH A HOLE IN THE BALLOON INTO THE ARTERY. THE BALLOON WAS TAKEN OUT OF THE ARTERY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279723 ↗
• MalfunctionJul 8, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. A 3.0X60X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS FOUND DIFFICULT TO DEFLATE AFTER THE INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690734 ↗
• MalfunctionFeb 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE (PVD). THE >70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE VESSEL WAS WIRED WITH A ROTA FLOPPY WIRE AND ATHERECTOMY WAS PERFORMED WITH A 2.0 ROTA LINK BURR. POST ATHERECTOMY, A 3.0X60X150 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR <30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3 X 60 STERLING BALLOON CATHETER WITH NO ISSUES. ONCE IT WAS REMOVED POST INTERVENTIONAL ARTERIOGRAM WAS PERFORMED WITH NO RESIDUAL STENOSIS NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377791 ↗