Sterling™ H74939032602080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729123750), received between Nov 28, 2018 and Aug 7, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND WHEN REMOVED, A PIECE OF THE BALLOON WAS MISSING. A 6.0MMX20MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 14 ATMOSPHERES. UPON REMOVING THE DEVICE, IT WAS OBSERVED THAT A PIECE OF THE BALLOON WAS MISSING. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744025 ↗
• MalfunctionJul 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SHUNT UPPER ARM VEIN. A 6.0MMX20MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT NOMINAL PRESSURE FOR 40 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671636 ↗
• MalfunctionJan 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 95% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. A 6.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137488 ↗
• MalfunctionFeb 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 6.0MMX20MMX80CM (4F) FG STERLING OTW BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FOURTH INFLATION AT 14 ATMOSPHERES FOR 3 MINUTES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560088 ↗
• MalfunctionJan 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 6.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 40 SECONDS, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED AND A PINHOLE WAS NOTED IN THE MIDDLE PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 13196409 ↗
• MalfunctionDec 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 6.0MM X 20MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930433 ↗
• MalfunctionJul 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED MULTIPLE TIMES; HOWEVER, IT RUPTURED AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228545 ↗
• MalfunctionApr 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 11 ATMOSPHERES, THE BALLOON RUPTURED . THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936526 ↗
• MalfunctionApr 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM VEIN. A 6.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, UPON INITIAL INFLATION AT 10 ATMOSPHERES FOR 4 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501628 ↗
• MalfunctionNov 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX20MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE SECOND INFLATION AT 6 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110513 ↗