Sterling™ H74939031454010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729757078), received between Oct 9, 2018 and Jan 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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.

• MalfunctionJan 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERIES. AFTER A FILTERWIRE EZ CROSSED THE LESION, A 4.5MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON DID NOT DILATE. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY, AND IT WAS OBSERVED THAT THE BALLOON RUPTURED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196458 ↗
• MalfunctionSep 20, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT UNDERWENT CAROTID ARTERIAL STENTING (CAS). THE TARGET LESION WAS LOCATED IN THE INTERNAL AND COMMON CAROTID ARTERY. AFTER THE GUIDING CATHETER PLACEMENT, FILTER-WIRE EZ (FWEZ) EMBOLIC PROTECTION DEVICES WAS INDUCED AND WAS DILATED WITH 3.0X30MM STERLING BALLOON CATHETER. THE PHYSICIAN THEN IMPLANTED A CAROTID WALLSTENT (CWS). A 4.5MM X 40MM X 135CM STERLING BALLOON CATHETER WAS USED FOR POST INFLATION. WHEN THE BALLOON WAS ATTACHED TO THE Y-CONNECTOR, THERE WAS SEVERE RESISTANCE IN THE GUIDING CATHETER. THE SAME SYMPTOMS WERE OBSERVED WHEN THE BALLOON WAS REMOVED AND REINSERTED. THEREFORE, IT WAS JUDGED THAT THE BALLOON COULD NOT BE USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456259 ↗
• MalfunctionJul 20, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. AFTER A CAROTID WALLSTENT WAS PLACED, A 4.5MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, STRONG RESISTANCE WAS FELT WHEN INSERTING TO THE GUIDE CATHETER AND THE SAME SITUATION WAS OBSERVED WHEN THE BALLOON WAS REMOVED AND REINSERTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064597 ↗
• MalfunctionOct 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER THROMBUS REMOVAL USING A NON BSC DEVICE, CAROTID STENTING WAS PERFORMED AND A 4.5MM X 40MM X 135CM STERLING BALLOON CATHETER WAS USED FOR POST DILATATION. DURING INFLATION, AN OUTFLOW OF CONTRAST MEDIA FROM THE BALLOON WAS NOTED AND USAGE OF DEVICE WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949566 ↗