Sterling™ H74939031603010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729757276), received between Jan 24, 2019 and Nov 7, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A 6.0MM X 30MM X 135CM STERLING BALLOON CATHETER WAS SELECTED FOR USE IN A CAROTID PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE 60% STENOSED CAROTID VESSEL WAS NOT TORTUOUS AND MODERATELY CALCIFIED. DURING POST-DILATATION OF A NON-BOSTON SCIENTIFIC CAROTID STENT, THE BALLOON BURST ON THE FIRST INFLATION AT 12 ATMOSPHERES (ATM) AFTER THREE SECONDS. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT A NEW BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626563 ↗
• InjuryOct 21, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A BALLOON LEAK CAUSED AN AIR EMBOLISM, WHICH LED TO A PATIENT STROKE. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED CAROTID ARTERY. A 6.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS USED TO PRE-DILATE A NON-BOSTON SCIENTIFIC STENT. HOWEVER, THE PHYSICIAN NOTICED A LEAK IN THE BALLOON AS IT COULD NOT INFLATE. AFTER TRYING TO INFLATE THE BALLOON TWICE, THE AIR IN THE BALLOON LEAKED OUT CAUSING A STROKE TO THE PATIENT DUE TO THE AIR EMBOLISM. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS TRANSFERRED TO A STROKE UNIT AT ANOTHER HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT IS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE BALLOON HAD BEEN FLUSHED TO REMOVE THE AIR PRIOR TO USE, BUT IT WAS NOT INFLATED PRIOR TO USE. THE DEVICE WAS INFLATED USING A MIXTURE OF SALINE AND CONTRAST MEDIUM AND A NORMAL INFLATION DEVICE. AFTER THE BALLOON WAS INFLATED TO ONLY A FEW ATMOSPHERES, THE PHYSICIAN NOTICED A HOLE IN THE BALLOON. PRIOR TO THE PROCEDURE, THE PATIENT STATUS WAS STABLE, BUT DURING THE PROCEDURE USING COMPUTERIZED TOMOGRAPHY, THE AIR EMBOLISM WAS CONFIRMED. THE PATIENT HAD RECOVERED

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 20494658 ↗
• MalfunctionMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH PULMONARY ARTERIAL HYPERTENSION AND CHEST PAIN DURING MOVEMENT AND EDEMA OF LOWER LIMBS. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED PULMONARY ARTERY. A 6.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WHEN PRESSURE WAS INCREASED TO 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308536 ↗
• MalfunctionApr 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAK AT THE TIP OCCURRED, AND BALLOON COULD NOT HOLD PRESSURE. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 6.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR POST DILATATION DURING CAROTID ARTERY STENT PLACEMENT. THE PRESSURE WAS INCREASED TO NOMINAL USING A PTA BALLOON INDEFLATOR. HOWEVER, THE BALLOON SLOWLY DEFLATED, AND THE CONTRAST AGENT APPEARED TO LEAK OUT OF THE BALLOON. THE PRESSURE WAS REDUCED AND THEN IT WAS INCREASED AGAIN, THE PRESSURIZED STATE COULD NOT BE MAINTAINED, AND THE CONTRAST AGENT APPEARED TO LEAK FROM THE TIP OF THE BALLOON. 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 19021067 ↗
• MalfunctionJan 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY IN THE C1 SEGMENT. A 6.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED IN A ROUTINE MANNER, PUMPED THE PRESSURE BACK FOR SEVERAL SECOND AND RAPIDLY INCREASED PRESSURE UNTIL THE BALLOON IS FULLY FORMED. THE RADIOGRAPHY SHOWED THAT THE DILATION OF C1 SEGMENT WAS ALMOST THE SAME WITH THE PRE-OPERATION, BUT THE STENOSIS STILL REMAINED. THE BALLOON WAS RE-DILATED AT 8 ATMOSPHERES, BUT THE PRESSURE PUMP WAS UNSUCCESSFULLY PRESSURIZED. THE DEVICE WAS WITHDRAWN AND FOUND THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573752 ↗
• MalfunctionMay 9, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-APR 2023. IT WAS REPORTED THAT BALLOON LEAK WAS ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. AFTER THE LEFT FEMORAL ARTERY WAS PUNCTURED AND AN 8F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS PLACED AND A NON-BSC GUIDEWIRE WAS REACHED AT THE DISTAL LEFT COMMON CAROTID ARTERY, A 9X40 WALLSTENT WAS THEN DEPLOYED. POST-DILATATION WAS PERFORMED WITH A 6.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER. HOWEVER, DURING THIRD INFLATION AT 7 ATMOSPHERES, THE BALLOON LEAKED. THE BALLOON WAS REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED. THE STENOSIS WAS SIGNIFICANTLY RELIEVED, WITH GOOD STENT ATTACHMENT, IDEAL POSITION AND SMOOTH BLOOD FLOW. THE PATIENT WAS STABLE AND HAD NO DISCOMFORT REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899973 ↗
• MalfunctionOct 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 6.0MMX30MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 12610565 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED INTERNAL CAROTID ARTERY. A BSC FILTERWIRE WAS PLACED IN POSITION AND THE LESION WAS PRE-DILATED WITH A STERLING BALLOON. A 8.0-29 CAROTID WALLSTENT WAS THE ADVANCED TO THE LESION. THE DEVICE HAD DIFFICULTIES IN CROSSING BUT EVENTUALLY CROSSED AND THE STENT WAS PLACED WITHOUT FURTHER PROBLEMS. SUBSEQUENTLY, THE LUMEN WAS VIEWED WITH AN OPTICROSS 18 IMAGING CATHETER AND POST-DILATATION USING A 6.0MM X 30MM X 135CM STERLING BALLOON CATHETER. BLEEDING WAS OBSERVED FROM THE CENTER OF THE STENT. PROTAMINE WAS INJECTED, DILATATION USING A 6MM BALLOON WAS PERFORMED, AND THE NECK REGION WAS COMPRESSED TO STOP THE BLEEDING AND THE PROCEDURE WAS COMPLETED. THE PATIENT LEFT THE OPERATING ROOM WITHOUT SYMPTOMS. PHYSICIAN COMMENTED THAT THE BLEEDING MIGHT HAVE BEEN CAUSED BY THE STENT GETTING CAUGHT WHILE PASSING THROUGH THE STENOSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT VESSEL PERFORATION WAS NOT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 11066220 ↗
• MalfunctionSep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 6.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL PRESSURE FOR 60 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8991110 ↗
• MalfunctionFeb 13, 2019Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-JAN-2019. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 6.0MMX30MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, FAILURE OF THE BALLOON WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336952 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN A CAROTID STENT. A 6.0MMX30MMX135CM STERLING BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE SHAFT BROKE AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274647 ↗