Sterling™ H74939031503010Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729757122), received between Oct 15, 2018 and Sep 2, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Entrapment of Device; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569607 ↗
• MalfunctionFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT HAD A 75% STENOSIS OF THE SUBCLAVIAN ARTERY AND UNDERWENT STENT ANGIOPLASTY. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258055 ↗
• MalfunctionJan 8, 2026Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION POST STENT DEPLOYMENT. DURING THE PROCEDURE, THE BALLOON FAILED TO DILATE AND WAS RUPTURED. 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 24010446 ↗
• MalfunctionJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PREPARATION, THE HEPARINIZED SALINE SOLUTION WAS NOTED TO HAVE LEAKED FROM THE BALLOON PART. 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 23972604 ↗
• MalfunctionNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, AS THE PRESSURE OF THE INFLATOR CONTINUED TO DROP, THE PHYSICIAN CHECKED THE BALLOON AND FOUND THAT THE HEAD PART OF THE BALLOON WAS PERFORATED. 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 23522079 ↗
• MalfunctionJun 16, 2025Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 5.0MMX30MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. UNDER FLUOROSCOPIC GUIDANCE, THE BALLOON WAS INFLATED USING A PRESSURE PUMP. HOWEVER, CONTRAST MEDIUM LEAKAGE WAS OBSERVED, AND THE BALLOON FAILED TO INFLATE PROPERLY. THE BALLOON WAS SUBSEQUENTLY REMOVED FROM THE PATIENT FOR FURTHER EXAMINATION. UPON REMOVAL, IT WAS NOTED THAT THE BALLOON REMAINED UNINFLATED, CONTINUED TO EXHIBIT CONTRAST MEDIUM LEAKAGE, AND WAS FOUND TO BE RUPTURED. 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 22212883 ↗
• InjuryMay 12, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND SEPARATED IN THE BODY. THE STENOSED TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 5.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 6 ATMOSPHERES AND SEPARATED WITHIN THE BODY. RESISTANCE WAS ENCOUNTERED UPON ATTEMPTED REMOVAL OF THE BALLOON, HOWEVER, THE RETAINED FRAGMENT WAS SUCCESSFULLY SNARED AND REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT FURTHER COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004234 ↗
• MalfunctionApr 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE EVENLY AT NOMINAL PRESSURE. A SMALL AND TINY PINHOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885353 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 5.0MMX30MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BROKE WHEN INFLATED FOR PRE-DILATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED UPON FIRST INFLATION AT ABOUT 10 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368027 ↗
• MalfunctionApr 18, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON COULD NOT STABILIZE THE PRESSURE, THE FLUID IN THE PRESSURE PUMP WAS LOST AND BLOOD APPEARED, AND THE BALLOON WAS NOT FULLY OPENED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE PHYSICIAN FOUND THAT THE BALLOON HAD A PINHOLE. 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 19137845 ↗
• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MM X 30MM X 135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051831 ↗
• MalfunctionFeb 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR PERCUTANEOUS ARTERIAL STENT IMPLANTATION. THE 80% STENOSED TARGET LESION WAS LOCATED IN INTERNAL CAROTID ARTERY C1 SEGMENT. A 5.0MM X 30MM X 135CM STERLING BALLOON CATHETER WAS USED FOR DILATION. HOWEVER, THE BALLOON WAS FOUND TO BE FLATTENED IN SHAPE AND RUPTURED AFTER REMOVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384840 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2022, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION 1 WAS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.8MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.9MM WITH LESION LENGTH OF 25 MM AND 80% STENOSIS. PRIOR TO TARGET LESION TREATMENT, PRE-DILATION WAS PERFORMED WITH 5.0 MM X 30 MM STERLING BALLOON CATHETER. A GRADE B DISSECTION WAS NOTED DURING ANGIOPLASTY. IN RESPONSE TO THE EVENT, BALLOON DILATION WAS PERFORMED AND TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF 6 MM X 40 MM ELUVIA DRUG ELUTING STENT. FOLLOWING POST DILATATION WAS PERFORMED WITH 6.0 MM X 30 MM STERLING BALLOON. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0% AND THE COMPLICATION WAS RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 15068286 ↗
• MalfunctionJun 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MM X 30MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14558565 ↗
• MalfunctionDec 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER PLACING A CAROTID WALLSTENT, A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INFLATION, THE PRESSURE DID NOT INCREASE AND CONTRAST MEDIA LEAKAGE WAS NOTED. BALLOON RUPTURE WAS SUSPECTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482762 ↗
• MalfunctionDec 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395226 ↗
• MalfunctionAug 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED INTERNAL CAROTID ARTERY. A 5.0MM X 30MM X 135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, WHEN THE BALLOON WAS TRIED TO INFLATE OUTSIDE THE PATIENT'S BODY, THE BALLOON GOT DAMAGED/BROKEN AND IT DID NOT INFLATE/EXPAND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8929765 ↗
• MalfunctionJun 19, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PRE-TESTING THE BALLOON OUTSIDE THE PATIENT'S BODY, IT WAS NOTED THAT THE BALLOON COULD NOT BE WITHDRAW AFTER INFLATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8714069 ↗
• InjuryOct 15, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT CAROTID ARTERY. AFTER A V-18 WIRE CROSSED THE LESION, A 5.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE DEVICE REACHED THE LESION AND THE PHYSICIAN WAS ADJUSTING AND PRESSING, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS RETRIEVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965973 ↗