Sterling™ H74939032406010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729123644), received between Apr 9, 2020 and Jan 14, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17DEC2025. IT WAS REPORTED THAT BALLOON DID NOT FULLY EXPAND. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED UP TO 23 ATMOSPHERES, HOWEVER THE BALLOON DID NOT FULLY EXPAND IN THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BALLOON IS SEPARATED 7MM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069315 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MMX60MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON BEGAN LEAKING CONTRAST AND NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 4X220 STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007089 ↗
• MalfunctionApr 21, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 4.0MMX60MMX135CM (4F) FG STERLING BALLOON CATHETER, IT WAS FOUND THAT THE BALLOON WAS BROKEN. THE DEVICE WAS NEVER USED INSIDE THE PATIENT'S BODY. 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 16782701 ↗
• MalfunctionOct 20, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON HAD DEFLATION ISSUES. A STERLING BALLOON CATHETER 4.00MM X 60MM, 135CM WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERIAL OCCLUSIVE DISEASE BY PERFORMING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE PHYSICIAN INFLATED THE BALLOON TO NOMINAL PRESSURE; HOWEVER, THE BALLOON WAS NOT ABLE TO BE DEFLATED. THE CATHETER WAS ABLE TO BE REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER STERLING DEVICE WITHOUT SEQUALA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15644394 ↗
• MalfunctionApr 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT LEG. A 4.0MMX60MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044747 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE HEAVILY DISEASED TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 4.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION POST-LASER. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMALLER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691145 ↗
• MalfunctionApr 9, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THERE WAS A DEVICE PACKAGING ISSUE. A 4.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. IT APPEARED THAT THE DEVICE LOOKED LIKE IT WAS ALREADY OPENED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9943753 ↗