Sterling™ H74939031553010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729757191), received between Dec 3, 2019 and May 8, 2025 — 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 16, 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.

• MalfunctionMay 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PINHOLE LEAKS OCCURRED. A 5.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES, IT WAS NOTED THAT PINHOLE-LIKE LEAKS OCCURRED FROM THE BALLOON. USE OF THE DEVICE WAS DISCONTINUED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985746 ↗
• MalfunctionAug 27, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. A 5.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED AND UPON INSPECTION OUTSIDE THE BODY, A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075177 ↗
• MalfunctionSep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER PLACING A FILTERWIRE EZ IN THE LESION, A 5.5MMX30MMX135CM (4F) STERLING WAS ADVANCED FOR PRE-DILATATION. FOLLOWING IMPLANTATION OF A CAROTID WALLSTENT (CWS), A 5.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER ADVANCED FOR POST-DILATATION BUT INFLATION COULD NOT BE DONE. THE DEVICE WAS RETRIEVED, AND A PINHOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680723 ↗
• MalfunctionJul 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED INTERNAL CAROTID ARTERY. A 5.5MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, DURING SETUP, THE BALLOON FAILED TO RELEASE AIR AND COULD NOT APPLY NEGATIVE PRESSURE DESPITE MULTIPLE ATTEMPTS. UPON CHECKING, IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17348132 ↗
• MalfunctionJun 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CAROTID ARTERY. A 5.5MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132542 ↗
• MalfunctionDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.5MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402206 ↗