Sterling™ H74939031353010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729756910), received between Jun 26, 2019 and Mar 13, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED INTERNAL CAROTID ARTERY. A 3.5MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING SECOND INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED FROM A PINHOLE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITHOUT THIS OR ANY REPLACEMENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589400 ↗
• MalfunctionOct 30, 2025Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED INTERNAL AND COMMON CAROTID ARTERIES. A 3.5MMX30MMX135CM (4F) STERLING BALLOON WAS SELECTED FOR USE IN A CAROTID ARTERY STENTING (CAS) PROCEDURE. DURING PREPARATION, THE DEVICE WAS HANDLED CAREFULLY, AND NO PARTICULAR ISSUES WERE NOTED. HOWEVER, THE USE OF THIS DEVICE WAS DISCONTINUED DUE TO A FOREIGN SUBSTANCE PRESENT IN THE DEVICE. THE CAUSE REMAINS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425917 ↗
• MalfunctionSep 5, 2025Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE AVERAGE TORTUOUS VESSEL. A 3.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PREPARATION. THE BALLOON SHOWED POOR INFLATION AND LEAKED FROM THE TIP WHEN PRESSURE WAS APPLIED. DESPITE REPEATED CHECKS UNDER FLUOROSCOPY, PROPER EXPANSION COULD NOT BE CONFIRMED. VISIBLE DAMAGE COULD NOT BE NOTICED BUT IT WAS CONSIDERED TO BE A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978110 ↗
• MalfunctionJul 13, 2022Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN INTERNAL CAROTID ARTERY. A 3.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED THROUGH THE FILTER-WIRE EZ (FWEZ). HOWEVER, THE WIRE DID NOT COME OUT OF THE MONORAIL LUMEN, RESISTANCE WAS FELT AND THE DEVICE COULD NOT BE PULLED OUT. MULTIPLE ATTEMPTS WERE MADE TO CROSS THE WIRE THROUGH THE FWEZ, BUT IT GOT STUCK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008732 ↗
• MalfunctionOct 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON CALCIFIED COMMON CAROTID ARTERY. AFTER THE INDEFLATOR WAS PREPARED, A 3.5MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE INFLATION OF THE BALLOON COULD NOT BE CONFIRMED UNDER FLUOROSCOPY. THE BALLOON WAS RETRACTED AND A BALLOON RUPTURE WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724331 ↗
• MalfunctionJun 26, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN THE DEVICE. A 3.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, A HAIR WAS FOUND ON THE HOLDER OF THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734414 ↗