Sterling™ H74939031303010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729756873), received between Dec 19, 2018 and Mar 19, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED POPLITEAL ARTERY. A 3.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 7 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. A DIFFERENT HP BALLOON WAS THEN USED FOR DILATION, FOLLOWED BY FURTHER DILATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH AN UPSIZED BALLOON. A STENT WAS SUBSEQUENTLY DEPLOYED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641788 ↗
• MalfunctionJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. A 3.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 23973786 ↗
• MalfunctionOct 27, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 3.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, A STRAND OF HAIR WAS NOTED WHILE REMOVING THE DEVICE FROM THE CAP FOR POLISHING. 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 23391148 ↗
• MalfunctionAug 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 91% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED C1. A 3.0MMX30MMX135CM STERLING BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS CAROTID ARTERY STENTING. DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR FIVE SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED WITH GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804309 ↗
• MalfunctionDec 19, 2024Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 3.0MMX30MMX135CM (4F) STERLING BALLOON WAS SELECTED FOR DILATION. HOWEVER, WHEN PREPARING FOR THE PROCEDURE, IT WAS NOTED THAT A PIECE OF THE TIP WAS MISSING AND IT WAS INCOMPLETE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE TIP WAS NOT DETACHED, BUT A PIECE WAS MISSING. FURTHERMORE, NO ANOMALIES WERE NOTED WITH THE POUCH PRIOR TO USE, NOR HAD IT BEEN PREVIOUSLY OPENED OR USED. AN ATTEMPT WAS MADE TO VISUALIZE THE MISSING PIECE OF THE TIP UNDER FLUOROSCOPY, BUT IT COULD NOT BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20982801 ↗
• MalfunctionNov 15, 2024Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-OCT-2024. IT WAS REPORTED THAT BALLOON FAILURE TO INFLATE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CAROTID ARTERY. A 3.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, AFTER MULTIPLE INFLATION ATTEMPTS AT NORMAL ATMOSPHERIC PRESSURE, THE BALLOON WOULD NOT INFLATE. THERE WAS NO PINHOLE, LEAK, OR TEAR NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE AND TIP SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693332 ↗
• MalfunctionJun 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. DURING UNPACKING OF A 3.0MMX30MMX135CM (4F) FG STERLING BALLOON CATHETER, THE BALLOON WAS NOTED TO BE LEAKING WHEN IT WAS FLUSHED, AND A PINHOLE ON THE BALLOON MATERIAL WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139162 ↗
• InjuryFeb 27, 2023Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 3.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS TRIED TO BE REMOVED AFTER INFLATION AND DEFLATION, MORE RESISTANCE WAS FELT THAN USUAL, BUT WHEN IT WAS PULLED, THE BALLOON PART WAS SEPARATED. THE SEPARATED PART WAS RETRIEVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT IT WAS A CATHETER SHAFT SEPARATION, AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC FOR POST DILATION. THE PATIENT RECOVERED WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444648 ↗
• MalfunctionNov 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED INTERNAL CAROTID ARTERY. A 3.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED WHILE INCREASING THE PRESSURE FROM 3 ATMOSPHERES TO 4 ATMOSPHERES DURING THE INITIAL INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820949 ↗
• MalfunctionAug 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 3.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, ON THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414178 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A 3.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, THE DEVICE WAS FOUND FRACTURED AFTER UNPACKING BEFORE USAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8179163 ↗