Sterling™ H74939032802080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729720645), received between Mar 23, 2020 and Jun 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. AN 8.0MMX20MMX80CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED, AND SALINE OF THE CONTRAST AGENT SEEMED TO BE LEAKING. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210020 ↗
• MalfunctionMar 19, 2024Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. AN 8.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. UPON DEFLATION, THE BALLOON COULD NOT BE DEFLATED PROPERLY. THE DEVICE WAS REPLACED WITH ANOTHER PRODUCT AND COMPLETED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933029 ↗
• MalfunctionAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PULMONARY ARTERY. AN 8.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17447621 ↗
• MalfunctionJul 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PULMONARY ARTERY. AN 8.0MMX20MMX80CM (4F) AND A 7.0MMX20MMX80CM (4F) STERLING BALLOON CATHETERS WERE ADVANCED RESPECTIVELY FOR DILATION. THESE BALLOONS WERE INITIALLY INFLATED AT 6 ATMOSPHERES FOR 30 SECONDS. HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, BOTH BALLOONS RUPTURED AND SEPARATED VERTICALLY. THE DEVICES WERE REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12187430 ↗
• MalfunctionJul 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL APPROACH OF THE FEMORAL ARTERY. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. AFTER A GUIDEWIRE WAS PASSED THROUGH, A 8.0MM X 20MM X 80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317367 ↗
• MalfunctionMar 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST DILATATION THE BALLOON RUPTURED AT 4 ATMOSPHERE FOR 5 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867983 ↗