Sterling™ H74939031703010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729757566), received between Mar 20, 2020 and Jan 20, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FAILURE IN MAINTAINING PRESSURE OCCURRED. THE PATIENT WAS PRESENTED WITH CAROTID ARTERY STENOSIS AND UNDERWENT INTRACRANIAL ANGIOGRAPHY AND BALLOON DILATATION. THE 99% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED CAROTID ARTERY. A 7.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. THE DEVICE WAS INITIALLY INFLATED FOR 15 SECONDS; HOWEVER, THE BALLOON KEPT LEAKING GAS AND COULD NOT HOLD PRESSURE EVEN AFTER MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218104 ↗
• InjuryMar 20, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 7.0MMX30MMX135CM 4 FRENCH STERLING BALLOON CATHETER WAS ADVANCED FOR TREATMENT. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. ANGIOGRAM WAS PERFORMED IN THE LEFT INTERNAL ILIAC ARTERY. THERE WAS NO ABNORMALITY FOUND WHEN THE BALLOON WAS INFLATED. THE PHYSICIAN RELEASED THE PRESSURE IN THE BALLOON AND WITHDREW THE BALLOON TO ADJUST THE POSITION. IT WAS FOUND THE BALLOON COULD NOT MOVE. THE PHYSICIAN EXERTED FORCE AND THE BALLOON COULD SLIGHTLY MOVE. THE PHYSICIAN EXERTED FORCE AGAIN; HOWEVER, THE BALLOON COULD NOT MOVE BUT THE DELIVERY SHAFT COULD BE WITHDRAWN. THE DELIVERY SHAFT WAS REMOVED FROM THE PATIENT; HOWEVER, THE BALLOON WAS LEFT IN LEFT INTERNAL ILIAC ARTERY. SURGERY OCCURRED RETRIEVE THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9860527 ↗