Sterling™ H74939031453010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729757054), received between Jul 12, 2022 and Sep 16, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionSep 16, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT BALLOON TORN OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED CAROTID ARTERY. A 4.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON DID NOT INFLATE. THE DEVICE WAS THEN REMOVED FROM THE BODY AND CHECKED. IT WAS CONFIRMED THAT THE BALLOON WAS TORN AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH NON-BOSTON SCIENTIFIC DEVICE, AND THE TREATMENT PROGRESSED WITHOUT ANY ISSUES. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224598 ↗
• MalfunctionJul 2, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED INTERNAL CAROTID ARTERY. A 4.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. UPON INFLATION, IT WAS NOTED THAT THE BALLOON RUPTURED, AND A LEAK OF CONTRAST MEDIUM WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655596 ↗
• MalfunctionMar 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON HOLE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CAROTID ARTERY. A (B)(6) STERLING BALLOON CATHETER WAS SELECTED FOR USE, THE PREPARATION WAS PERFORMED FOR PRE-DILATION, HOWEVER, IT WAS NOTED THAT THERE WAS A HOLE IN THE BALLOON. THE USAGE WAS CONTINUED, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937952 ↗
• MalfunctionAug 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.5MMX30MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING TEST INFLATION OUTSIDE THE PATIENT, THE BALLOON RUPTURED DURING FIRST INFLATION AT 2 ATMOSPHERES FOR 2 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632567 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE 100% TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY POPLITEAL ARTERY. A 4.5MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126758 ↗
• MalfunctionJul 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 4.5MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. THE DEVICE UNABLE TO INFLATE AND THE PRESSURE OF THE INFLATOR DID NOT INCREASE. A BALLOON RUPTURE WAS SUSPECTED. THE DEVICE WAS REMOVED AND INFLATION WAS TRIED OUTSIDE THE PATIENT, THE CONTRAST AGENT LEAKED AND A BALLOON RUPTURE HAS OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14996375 ↗