Sterling™ H74939032300490Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729860143), received between Apr 15, 2020 and Sep 26, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS SHUNT. A 3.0X40X90 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE IT WAS INFLATED TO NOMINAL BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317038 ↗
• MalfunctionJan 31, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT WIRE ENTRAPMENT OCCURRED. A 3.0X40X90 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR TREATMENT. DURING PROCEDURE, THE WIRE GOT STUCK IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614767 ↗
• MalfunctionDec 22, 2023Leak/Splash; Component Missing; Material Integrity Problem; Leak/Splash; Component Missing; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14DEC2023. IT WAS REPORTED THAT THE BALLOON LEAKED DURING INFLATION. A STERLING BALLOON WAS SELECTED FOR USE TO TREAT AN OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). WHILE UNPACKAGING THE BALLOON FROM THE PACKAGING, IT WAS OBSERVED THAT THE BALLOON WAS MISSING A COMPONENT, AND THE BALLOON APPEARED UNFOLDED. INFLATION WAS ATTEMPTED BUT THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH A NEW STERLING BALLOON. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A TEAR IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18386555 ↗
• MalfunctionApr 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BALLOON ISSUE OCCURRED. A 3.0MM X 40MM X 90CM STERLING OVER-THE-WIRE BALLOON CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, THE BALLOON WAS SEPARATED FROM THE SHAFT. THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190607 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. A 3.0X40X90 STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE BALLOON WAS TAKEN OUT OF THE STERILE PACKET, IT WAS MISSHAPED. THE PROXIMAL PART OF THE BALLOON WAS BENT AND PART OF THE BALLOON WAS SPLIT OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11019518 ↗
• MalfunctionApr 15, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. A 3.0X40X90 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION OUTSIDE THE PATIENT, THE DEVICE APPEARED TO BE FRAYED OR DISINTEGRATED AT THE END OF THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9962914 ↗