Sterling™ H74939031354010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729756927), received between Mar 20, 2019 and Mar 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Fluid/Blood Leak; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT INTERNAL CAROTID ARTERY. DURING THE PROCEDURE, AFTER CROSSING THE LESION WITH THE FITERWIRE EZ, INFLATION WAS ATTEMPTED IN ORDER TO PERFORM PRE-DILATION. HOWEVER, THE BALLOON DID NOT EXPAND UPON INFLATION, AND DILATION COULD NOT BE PERFORMED. THERE WAS NO NOTICEABLE DAMAGE WAS FOUND, BUT CONTRAST MEDIUM WAS LEAKING FROM THE BALLOON PART, WHICH SUGGESTED THERE MAY HAVE BEEN A TEAR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546561 ↗
• MalfunctionDec 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED POPLITEAL ARTERY. A 3.5MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURY REPORTED AND THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10994458 ↗
• MalfunctionJun 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED INTERNAL CAROTID ARTERY. A 3.5MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212202 ↗
• MalfunctionMar 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED BELOW THE KNEE ARTERY. A 3.5MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE CONTRAST MEDIA WAS FOUND TO BE LEAKING UNDER FLUOROSCOPY AND UPON INITIAL INFLATION AT 4 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A COYOTE NC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436438 ↗