Sterling™ H74939031403010Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729756972), received between Aug 24, 2020 and Apr 20, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERIES. A 4.0MMX30MMX135CM (4F) STERLING MR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PREPARATION, THE BALLOON INFLATION WAS CHECKED. HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 24921582 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. AFTER GAINING VASCULAR ACCESS VIA THE RIGHT FEMORAL ARTERY USING AN 8F SHEATH, GUIDEWIRE AND CATHETER WERE ADVANCED INTO THE LEFT INTERNAL CAROTID ARTERY (ICA). AFTER ADVANCING THE GUIDEWIRE ENTERED INTO THE DISTAL END OF THE LEFT ICA, A FILTERWIRE WAS PLACED. A 4.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS UNPACKED AND ADVANCED INTO THE LESION FOR DILATION. HOWEVER, DURING INFLATION, CONTRAST MEDIUM EXTRAVASATION WAS FOUND. AFTER WITHDRAWAL, IT WAS FOUND THAT THE BALLOON WAS LEAKING LIQUID AND COULD NOT BE USED. ANOTHER 4.0MMX30MMX135CM (4F) STERLING BALLOON WAS USED FOR DILATION FOLLOWED BY PLACING A STENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879241 ↗
• MalfunctionMay 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. THE STENOSED TARGET LESION WAS LOCATED IN THE C1 SEGMENT OF THE INTERNAL CAROTID ARTERY. A 4.0MMX30MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. DURING PRE-PROCEDURAL PREPARATION, BEFORE THE DEVICE WAS UNPACKAGED, LIVE INSECTS WERE NOTED INSIDE THE INNER PACKAGING OF THE DEVICE. THERE WERE CONCERNS REGARDING THE QUALITY OF THE PRODUCT. A REPLACEMENT DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE SUBSTANCE IN THE INNER PACKAGE WAS A DIRT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073910 ↗
• MalfunctionDec 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN BODY IN THE SHEATH OCCURRED. THE PATIENT HAD 90% STENOSIS IN THE C1 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY AND THE PATIENT WAS UNDER LOCAL ANESHTHESIA. IMAGING REVEALED STENOSIS IN THE C1 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. THE 8FMACH1 GUIDE CATHETER WAS REPLACED, AND A GUIDE WIRE WAS INSERTED TO THE CAVERNOUS SINUS SEGMENT OF THE INTERNAL CAROTID ARTERY.THE BSC EZ FILTERWIRE WAS SELECTED AND PLACED AT THE DISTAL 2 CM OF THE LESION. DURING UNPACKING, A FOREIGN BODY WAS DISCOVERED IN THE DELIVERY SHEATH OF A STERLING 4.0MMX30X135CM BALLOON. ADDITIONALLY, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE BALLOON ALONG THE FILTER WIRE. THE BALLOON WAS REPOSITIONED, AND A 7X40 WALLSTENT WAS SUCCESSFULLY DEPLOYED ALONG THE FILTER WIRE. FOLLOW-UP ANGIOGRAPHY CONFIRMED PROPER STENT PLACEMENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921673 ↗
• MalfunctionDec 4, 2024Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 4.0MMX30MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE IN A COMMON CAROTID ARTERY. DURING THE PROCEDURE, IT WAS FOUND THAT IT HAD GAS IN THE STERILE PACKAGE AND THE DEVICE STERILITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845852 ↗
• MalfunctionMay 21, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A PINHOLE WAS OBSERVED IN THE BALLOON. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 4.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED USING A PRESSURE PUMP, IT WAS OBSERVED THAT THE BALLOON DID NOT DILATE PROPERLY, AND THE PRESSURE COULD NOT BE STABILIZED. CONSEQUENTLY, THE BALLOON WAS WITHDRAWN. UPON TESTING THE BALLOON IN VITRO, A PINHOLE WAS DISCOVERED, RENDERING THE BALLOON UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367943 ↗
• MalfunctionApr 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. A 4.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE INFLATION WAS PERFORMED BUT THE PRESSURE DID NOT INCREASE. IT WAS CONSIDERED THAT THE BALLOON RUPTURED UPON DELIVERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127731 ↗
• MalfunctionFeb 12, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEFLATION WAS SLOW. THE TARGET LESION WAS IN CAROTID ARTERY. A 4.0MMX30MMX135CM (4F) STERLING WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE INFLATION AND DEFLATION TIME WAS TOO SLOW. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686425 ↗
• MalfunctionDec 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PLACED UNDER LOCAL ANESTHESIA AND UNDERWENT ANGIOGRAPHY WHICH REVEALED OCCLUSION IN THE C1 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. AN 8F MACH1 GUIDE CATHETER WAS EXCHANGED AND PLACED AT THE OSTIAL OF INTERNAL CAROTID ARTERY. ALONG THE GUIDE CATHETER, THE GUIDEWIRE WAS ADVANCED TO THE CAVERNOUS SINUS IN THE INTERNAL CAROTID ARTERY. A 2.0X15 NON-BOSTON SCIENTIFIC (BSC) BALLOON, A 3X20 BALLOON, AND A 4.0MMX30MMX135CM (4F) STERLING BALLOON WERE ADVANCED OVER GUIDEWIRE FOR DILATION. HOWEVER, THE 4.0MMX30MMX135CM (4F) STERLING BURST AND WAS REPLACED WITH ANOTHER OF SAME DEVICE. THE BALLOON WAS INFLATED TWICE, AND THE OCCLUSION WAS OBVIOUSLY IMPROVED. AFTER THE BALLOON CATHETER WAS REMOVED, AN EZ FILTERWIRE WAS PLACED AT 2CM DISTAL TO THE LESION FOLLOWED BY PLACING A 7X40 WALLSTENT AND COMPLETING THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL CAROTID ARTERY. ALSO, THE BALLOON BURST AT 8 ATMOSPHERES DURING THE INITIAL INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311093 ↗
• MalfunctionOct 4, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. THE MORE THAN 90% STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER AN EZ FILTER WIRE WAS PLACED 2CM AT THE DISTAL END OF THE LESION, A 4.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED TO BE LEAKING GAS. A NEW 4X30 STERLING BALLOON CATHETER WAS PLACED ALONG THE FILTER GUIDEWIRE TO PERFORMED DILATION. AFTER PRE-DILATATION, A 7X40 WALLSTENT STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867971 ↗
• MalfunctionAug 13, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED INITIAL SEGMENT OF THE LEFT CAROTID ARTERY. AFTER AN 8F GUIDING CATHETER WAS INSERTED COAXIALLY AND A HYDROPHILIC GUIDEWIRE REACHED THE DISTAL END OF THE LESION, A 9X40 WALLSTENT WAS PLACED. AFTERWARDS, 4.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INITIAL INFLATION THE BALLOON WAS LEAKING GAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538145 ↗
• MalfunctionJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERGO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE VASCULAR STENOSED TARGET LESION WAS LOCATED IN COMMON ILIAC ARTERY. A 4.0MM X 30MM X 135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE AT NOMINAL PRESSURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH MUSTANG BALLOON CATHETER AND THE VASCULAR STENOSIS WAS SUCCESSFULLY ALLEVIATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED. THE DEVICE WAS INFLATED ONCE AND RUPTURED AT 10 ATMOSPHERES FOR 30 SECONDS. AFTER WHICH, THE DEVICE WAS PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263569 ↗
• MalfunctionDec 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH INTRA-STENT RESTENOSIS IN C1 SEGMENT AND UNDERWENT ARTERIAL BALLOON DILATION AND A STENT IMPLANTATION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. AN 8F BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED AND A FILTERWIRE EZ GUIDEWIRE WAS CROSSED THE LESION. A 4.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. DURING THE PROCEDURE, THE BALLOON WAS DILATED AT 5 ATMOSPHERES (ATM); HOWEVER, THE PHYSICIAN NOTICED THAT THE BALLOON CANNOT BE DILATED ANY FURTHER AND THE PRESSURE WAS DECREASING. THE DEVICE WAS REMOVED FROM THE PATIENT BY NORMAL OPERATION AND FOUND THAT THE BALLOON HAS RUPTURED. PRE-DILATION WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND THE STENT IMPLANTATION WAS COMPLETED NORMALLY. THERE WERE NO COMPLICATIONS AND INJURIES REPORTED AND THE PATIENT WAS FINE AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939671 ↗
• MalfunctionDec 22, 2021Material Rupture; Material Rupture

  A 4.0MMX30MMX135CM STERLING BALLOON WAS SELECTED FOR USE. SOME CALCIFICATION WAS OBSERVED. DURING THE FIRST INFLATION AT THE TARGET LESION, THE BALLOON DID NOT INFLATE. THE INFLATION DEVICE PRESSURE DID NOT INCREASE AS WELL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13068278 ↗
• MalfunctionDec 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PULMONARY HYPERTENSION. THE STENOSED TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 4.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED TO DILATE THE BLOOD VESSEL TO LOWER THE PRESSURE. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED ON THE FIRST INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12937049 ↗
• MalfunctionNov 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED COMMON CAROTID ARTERY. A 4.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778668 ↗
• MalfunctionApr 23, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 4.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON DEFLATION TIME WAS SLOW. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717215 ↗
• MalfunctionAug 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND THE PATIENT WAS SENT TO SURGERY. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 4.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PATIENT WAS THEN SENT TO SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10442290 ↗