Sterling™ H74939032402010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729123521), received between Nov 13, 2018 and Sep 25, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300899 ↗
• MalfunctionMar 24, 2020Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON BROKE. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION IN THE INTERNAL AND COMMON CAROTID ARTERIES. DURING DEFLATION, THERE WAS A DIFFERENT SENSATION AND IT FELT LIKE NEGATIVE PRESSURE WAS RELEASING ON THE SYRINGE. WHEN ATTEMPTING TO INFLATE THE BALLOON, THE BALLOON BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT WHEN REMOVING AIR FROM THE DEVICE, NEGATIVE PRESSURE WAS FELT ESCAPING FROM THE SYRINGE. THE BALLOON WAS NOTICED TO BE TORN/RUPTURED/DAMAGED DURING AIR REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON CATHETER. THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874027 ↗
• MalfunctionNov 13, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED TO THE LESION. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR DILATATION. WHEN THE DEVICE WAS FLUSHED AND ADVANCED HALF-WAY, IT WAS NOTED THAT IT WAS STUCK ON THE WIRE. BOTH DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065451 ↗