Sterling™ H74939031552010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729755579), received between Jul 29, 2020 and Nov 10, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERIES. A 5.5MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, A BALLOON RUPTURED WAS NOTED DURING INFLATION CHECK AT THE TIME OF SETUP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518729 ↗
• MalfunctionJul 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL CAROTID TO COMMON CAROTID ARTERY. AFTER A FILTERWIRE EZ GUIDEWIRE CROSSED THE LESION, A 4-30 STERLNG BALLOON CATHETER WAS USED FOR PRE-DILATATION, FOLLOWED BY PLACEMENT OF A 10-31 CAROTID WALLSTENT. A 5.5MMX20MMX135CM STERLING BALLOON CATHETER WAS THEN ADVANCED FOR POST-DILATATION. HOWEVER, DURING INFLATION, LEAKAGE OF CONTRAST AGENT AND PINHOLE LEAK WAS OBSERVED. THE PROCEDURE WAS COMPLETED AS THE REQUIRED EXPANSION WAS OBTAINED. POST-PROCEDURE, VISUAL DILATATION WITH SALINE SOLUTION WAS PERFORMED BUT NO MAJOR LEAK OR IMAGE WAS OBSERVED IN THE BALLOON MATERIAL. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10340868 ↗