Sterling™ H74939032804080Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729720690), received between Mar 9, 2017 and Mar 22, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT SUBCLAVIAN VEIN. AN 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 24658990 ↗
• MalfunctionMar 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 68.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599914 ↗
• MalfunctionSep 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM VEIN. A 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION DURING PRESSURIZATION FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 20237761 ↗
• MalfunctionNov 15, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138977 ↗
• MalfunctionJul 11, 2023Difficult to Remove; Material Rupture; Failure to Deflate; Difficult to Remove; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE, REMOVAL DIFFICULTIES, AND BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT-HAND SHUNT. AN 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE SHEATH AFTER THE PROCEDURE, THE DISTAL TIP OF THE BALLOON WAS NOT DEFLATED, AND THE BALLOON WAS DIFFICULT TO REMOVE FROM THE SHEATH. IN SPITE OF MULTIPLE INFLATION AND DEFLATION WERE PERFORMED TO DEFLATE THE BALLOON, THE BALLOON TIP WAS NOT REWRAPPED; THEREFORE, THE BALLOON WAS INSERTED INTO THE SHEATH, THE BALLOON TIP RUPTURED. THEN, THE BALLOON WAS SUCCESSFULLY REWRAPPED AND REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299601 ↗
• InjuryApr 11, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES REQUIRING SURGICAL INTERVENTION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS VESSEL. A 8.0MM X 40MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE AND INFLATED TWO TIMES AT 6 ATMOSPHERES, THE CATHETER COULD NOT BE PULLED BACK INTO THE NON-BOSTON SCIENTIFIC (BSC) SHEATH. INFLATION AND DEFLATION WERE ATTEMPTED BUT RESISTANCE WAS PERSISTED. A SMALL INCISION WAS THEN MADE, AND THE DEVICE WAS REMOVED ALONG WITH THE NON-BSC SHEATH. THE CATHETER WAS INTACT ON THE DELIVERY SYSTEM WHEN THE DEVICE WAS REMOVED FROM THE PATIENT NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712579 ↗
• MalfunctionMar 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AN 8.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641163 ↗
• MalfunctionMar 15, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548252 ↗
• InjuryFeb 10, 2023Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A STERLING BALLOON CATHETER 8.00MM X 40MM, 80CM WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERIAL DISEASE. AFTER TREATMENT, THE BALLOON RUPTURED DURING REMOVAL. THE PHYSICIAN USED FORCEPS AND WERE ABLE TO REMOVE THE BALLOON COMPLETELY WITH FORCEPS BEFORE THE BALLOON FULLY DETACHED. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352739 ↗
• MalfunctionNov 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT ENDOVASCULAR THERAPY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VESSEL. A 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804076 ↗
• MalfunctionOct 5, 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 VENTRICULOATRIAL (VA) SHUNT. A 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544609 ↗
• MalfunctionSep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LEFT FOREARM. A 8.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422499 ↗
• MalfunctionSep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. (B)(4), DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED IN A VERTICAL SPLIT. THE 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 15422134 ↗
• MalfunctionJun 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ARTERIOSCLEROSIS OBLITERANS. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 8.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687824 ↗
• MalfunctionJan 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED BRACHIAL VEIN. A 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A VERTICAL RUPTURE WAS FOUND IN THE MIDDLE PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13247083 ↗
• MalfunctionSep 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC. AN 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INITIALLY INFLATED AT 8 ATMOSPHERES FOR 30 SECONDS; HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. 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 12479920 ↗
• InjuryNov 6, 2020Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, CATHETER REMOVAL DIFFICULTY, AND SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. AN 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE PHYSICIAN STATED THAT THE BALLOON WAS SLIPPERY IN THE LESION, SO THE PHYSICIAN INFLATED THE BALLOON WITH PULLING TENSION. WHEN THE BALLOON WAS REMOVED, IT BECAME STUCK. WHEN IT WAS PULLED, THE SHAFT GOT SEPARATED ABOUT 60CM FROM THE HUB. ALL DEVICE FRAGMENTS THAT REMAINED INSIDE THE BODY WERE RETRIEVED THROUGH OPERATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10801048 ↗
• MalfunctionNov 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED INSIDE THE PATIENT. AN 8.0MMX40MMX80CM STERLING BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE OF THE ILIAC ARTERY. THE LESION IN THE ILIAC ARTERY WAS DESCRIBED AS DIFFUSE AND CALCIFIED WITH A DIFFERENT MORPHOLOGY. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 8 ATMOSPHERES OF PRESSURE WHEN IT RUPTURED. THE PHYSICIAN WAS ABLE TO WITHDRAW THE BALLOON. A NEW BALLOON OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT HARMED. NO ADVERSE EFFECTS WERE REPORTED AND THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341797 ↗
• MalfunctionNov 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. AN 8.0MMX40MMX80CM STERLING BALLOON CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A CALCIFIED VESSEL. DURING THE PROCEDURE INSIDE THE PATIENT, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. ADDITIONAL INFORMATION REPORTED THAT THE PTA WAS OF A DIFFUSE AND CALCIFIC LESION WITH DIFFERENT MORPHOLOGY. THE BALLOON RUPTURED AT 8 ATM DURING PTA OF THE ILIAC ARTERY. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DEVICE FROM THE PATIENT. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9327931 ↗
• MalfunctionApr 29, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DEFLATION FAILURE OCCURRED AND FOREIGN OBJECT WAS NOTED ON THE DEVICE. THE 80% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) OF AN UNKNOWN STENT LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN VEIN. A 8.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR IN-STENT DILATATION. THE LESION WAS DILATED THREE TIMES AT 12 ATMOSPHERES EACH INFLATION. HOWEVER, AFTER THE 3RD DILATATION, DEFLATION FAILURE OCCURRED. FLUOROSCOPY REVEALED A FOREIGN OBJECT IN THE PRESENT INSIDE THE BALLOON. WHEN THE BALLOON WAS MOVED, THE FOREIGN OBJECT MOVED TOGETHER WITH IT. WHILE WAITING TO APPLY NEGATIVE PRESSURE, THE BALLOON GRADUALLY DEFLATED AND IT WAS SLOWLY REMOVED FROM THE SHEATH. UPON REMOVAL, THERE WAS NO RUPTURE ISSUE AND NO SEPARATION WAS NOTED. THE LESION WAS DILATED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. NO PATIENT SERIOUS INJURY NOR ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560734 ↗
• MalfunctionMar 9, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BASILIC VEIN. A 8.0MMX40MMX80CM (4F) STERLING¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. NO SEGMENT OF THE BALLOON WAS DETACHED INSIDE THE PATIENT AFTER IT RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6394100 ↗