Sterling™ H74939032702080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729124047), received between Mar 17, 2021 and Sep 25, 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.

• MalfunctionSep 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT LUNG. A 7.0 MM X 20 MM X 80 CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND OR THIRD INFLATION AT 12 TO 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151383 ↗
• MalfunctionJun 21, 2024Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PINHOLE FOUND ON THE SHAFT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 7.0MMX20MMX80CM STERLING BALLOON CATHETER WAS ADVANCE FOR DILATATION. HOWEVER, WHILE CONDUCTING THE PROCEDURE, A PINHOLE WAS IDENTIFIED ON THE SHAFT. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588849 ↗
• MalfunctionApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 7.0MM X 20MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 8 ATMOSPHERES FOR 8 SECONDS, THE BALLOON RUPTURED AT THE CENTER. 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 14219604 ↗
• 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 12187488 ↗
• MalfunctionMay 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 7.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES; HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795691 ↗
• MalfunctionMar 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 7.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A PINHOLE WAS NOTICED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505879 ↗