Sterling™ H74939031402010Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729756958), received between Mar 28, 2017 and Jan 21, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (28 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON RUPTURED DURING INFLATION CHECK IN SETUP PRIOR TO PATIENT USE. THE PROCEDURE WAS COMPLETED USING 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 24130448 ↗
• MalfunctionDec 19, 2025Material Twisted/Bent

  FROM STAFF: DURING FIRST CASE, THE STERLING BALLOON WAS OPENED TO THE BACK TABLE AND TAKEN ON OUT THE PROTECTIVE LOOP. THE CST [CERTIFIED SURGICAL TECHNICIAN] NOTICED THE KINK AT THE BEGINNING OF THE BALLOON. AFTER THE MD INSPECTED THE BALLOON AT THE BACK FIELD, THE DECISION WAS MADE TO NOT USE THE BALLOON, AND IT WAS PASSED OFF THE FIELD. BALLOON WAS NEVER TRANSFERRED TO THE PATIENT FIELD AND NEVER MADE IT TO THE PATIENT. A NEW DEVICE WAS OPENED AND USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849457 ↗
• MalfunctionSep 23, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR A STENTING PROCEDURE IN THE CAROTID ARTERY. DURING PREPARATION, THE BALLOON WAS FOUND TO BE DAMAGED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE ISSUE WAS WITH THE GUIDEWIRE AS IT COULD NOT ENTER THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279878 ↗
• InjuryJun 6, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED ALONG WITH A 0.18 GUIDE FOR RIGHT ARTERIOVENOUS FISTULA ANGIOPLASTY. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO POSITION IN THE TARGET SITE, AND THEN THE PROXIMAL PART OF THE SHAFT TO THE BALLOON BROKE. THE DEVICE WAS REMOVED USING A LOOP CATHETER. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480501 ↗
• MalfunctionJan 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567445 ↗
• MalfunctionDec 29, 2023Material 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 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419080 ↗
• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. AFTER PLACING A GUIDE CATHETER, A FILTERWIRE EZ WAS INDUCED AS ENDDIASTOLIC PRESSURE (EDP) FOLLOWED BY PRE-DILATATION. AFTER DEPLOYING A CAROTID WALLSTENT, POST-DILATATION WAS PERFORMED USING A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER. HOWEVER, DURING INFLATION, THE BALLOON FAILED TO INFLATE. AFTER REMOVAL, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE AND COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049862 ↗
• MalfunctionSep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680730 ↗
• InjuryAug 16, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED CELIAC ARTERY. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE CATHETER WAS WITHDRAWN; BUT THE DISTAL PORTION OF THE BALLOON INCLUDING BOTH RADIO OPAQUE MARKERS WERE STILL VISIBLE IN THE LESION WHEN INSPECTED UNDER FLUOROSCOPY. THE PHYSICIAN TRIED TO SNARE THE DETACHED POTION OF THE DEVICE FROM THE LESION BUT WAS UNSUCCESSFUL. EVENTUALLY, A NON-BOSTON SCIENTIFIC SELF-EXPANDING STENT WAS USED TO COVER THE DETACHED DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17558764 ↗
• MalfunctionJul 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ATTEMPTED TO INFLATE BUT NO PRESSURE WAS GENERATED DUE TO CALCIFICATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS RUPTURED WHEN IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPANY'S BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398945 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 6 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED AND SEPARATED VERTICALLY AT THE MIDDLE PART OF THE BALLOON. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087501 ↗
• MalfunctionNov 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, AFTER UNPACKING, A HOLE WAS FOUND ON THE BALLOON WHEN REMOVING AIR OR FLUSHING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15863758 ↗
• MalfunctionOct 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE HEPATIC VEIN. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS IS STABLE. IT WAS FURTHER REPORTED THE TARGET LESION WAS 70% STENOSED, NON-TORTUOUS AND MILDLY CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624707 ↗
• MalfunctionAug 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS SEVERELY CALCIFIED VESSEL. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 7 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15151544 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 3.0MMX20MMX135CM (4F) AND 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WERE USED IN THE SAME ORDER FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOONS RUPTURED VERTICALLY IN THE MIDDLE PART. THE BALLOONS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094975 ↗
• MalfunctionJun 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED SUBCLAVIAN ARTERY. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 60 SECONDS. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779852 ↗
• MalfunctionFeb 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED INTERNAL CAROTID ARTERY. AFTER A 6F NON-BSC GUIDE CATHETER AND A NON-BSC GUIDEWIRE CROSSED THE LESION, A NON-BSC EMBOLIC PROTECTION DEVICE WAS DEPLOYED AS PROTECTION. PREDILATATION WAS PERFORMED AND A NON-BSC STENT WAS PLACED INTO THE LESION. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON DID NOT EXPAND. THE DEVICE WAS REMOVED AND INFLATED OUTSIDE THE PATIENT'S BODY BUT THE BALLOON DID NOT EXPAND AND A HOLE IN THE BALLOON WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415527 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS USED TO DILATE THE BLOOD VESSELS TO REDUCE BLOOD PRESSURE. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908093 ↗
• MalfunctionOct 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 6 ATMOSPHERES FOR FEW SECONDS, THE BALLOON BURST. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12671494 ↗
• MalfunctionSep 9, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED COMMON CAROTID ARTERY. A 4.0MM X 20MM X 135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ANGIOGRAPHY SHOWED LEAKAGE OF CONTRAST MEDIUM DURING INFLATION. THE BALLOON WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446995 ↗
• MalfunctionAug 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310943 ↗
• MalfunctionApr 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED TO TREAT PERIPHERAL ARTERY DISEASE (PAD). HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM BY NORMAL METHOD. 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 11746472 ↗
• MalfunctionApr 5, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION SLOW OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS USED FOR DILATATION BUT IT WAS SLOW TO DEFLATE. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE LESION WAS 80% STENOSED AND SEVERELY TORTUOUS. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENTS BODY IN A DEFLATED STATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615081 ↗
• MalfunctionFeb 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL IN THE FOREARM. A 4.0MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. TH DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378082 ↗
• MalfunctionFeb 10, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON CATHETER SHAFT DETACHED WHEN THE BALLOON PROTECTOR WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307046 ↗