Sterling™ H74939032704080Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729124108), received between Mar 17, 2019 and Aug 17, 2026 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified cephalic vein. A 7.0mmX40mmX80cm (4F) Sterling balloon catheter was advanced for dilation. During the procedure, the balloon ruptured upon second inflation at 14 atmospheres for 30 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 50274603 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED BRACHIAL VEIN. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AND DID NOT INFLATE FROM THE FIRST TIME THE PRESSURE WAS INCREASED. 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 21998951 ↗
• MalfunctionNov 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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 AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761779 ↗
• MalfunctionNov 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 7.0MMX40MMX80CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 14 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 20732532 ↗
• MalfunctionNov 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN VEIN. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE MIDDLE PART OF THE BALLOON RUPTURED VERTICALLY UPON THIRD INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, 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 20702943 ↗
• MalfunctionJun 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED BRACHIAL VESSEL. A 7.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 19557012 ↗
• MalfunctionMar 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED BRACHIAL VEIN. A 7.0MMX40MMX80CM STERLING WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED VERTICALLY AT MIDDLE PART. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 18868206 ↗
• MalfunctionOct 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUBCLAVIAN VEIN. A 7.0MM X 40MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 12 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. 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 POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906425 ↗
• MalfunctionOct 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT BRACHIAL VEIN. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 3 MINUTES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 17899593 ↗
• MalfunctionJul 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE UPPER LEFT ARM. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17338163 ↗
• MalfunctionJun 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED DISTALLY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164276 ↗
• MalfunctionJun 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED, THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND MODERATELY CALCIFIED CEPHALIC VEIN. A 7.0MM X 40MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATION WAS PERFORMED SIX TIMES. HOWEVER, DURING THE SIXTH INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED VERTICALLY IN THE MIDDLE PART. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. AND THE PATIENT CONDITION WAS GOOD AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063564 ↗
• MalfunctionMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495608 ↗
• MalfunctionJan 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0MM X 40MM X 80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT 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 16090987 ↗
• MalfunctionDec 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE LIMB. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON RUPTURED IMMEDIATELY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 16060219 ↗
• MalfunctionNov 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN VEIN. A 7.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870341 ↗
• MalfunctionJul 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND NON-CALCIFIED LEFT FOREARM VEIN. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED AND DILATED THE CENTRAL SIDE WITHOUT PROBLEM. THE SAME DEVICE WAS USED TO EXPAND THE LESION ON THE PERIPHERAL SIDE. THE BALLOON WAS INFLATED TWICE. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES, THE LESION COULD NOT BE DILATED AND THE ELUTION OF THE CONTRAST MEDIUM FROM THE BALLOON WAS RECOGNIZED AS A RUPTURED. IT WAS NOTED THAT THERE WAS NO APPEARANCE OF A RUPTURE WHEN THE CENTRAL SIDE EXPANDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 15115347 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS VESSEL. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. 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 COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699473 ↗
• InjurySep 12, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON COULD NOT BE DEFLATED. THE SHEATH WAS REPLACED WITH 7FR, AND THE BALLOON WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457951 ↗
• MalfunctionJul 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE FOREARM. A 7.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246722 ↗
• MalfunctionApr 12, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED FOREARM VESSEL. AFTER A NON-BSC INTRODUCER SHEATH WAS INSERTED AND A NON-BSC GUIDEWIRE CROSSED THE LESION, A 7.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, IT WAS STUCK FOR ABOUT 30CM FROM THE TIP OF THE GUIDEWIRE. BOTH DEVICES WERE SIMPLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654188 ↗
• MalfunctionFeb 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LEFT FOREARM. AFTER PLACING 6FR NON-BOSTON SCIENTIFIC SHEATH, DILATION WAS PERFORMED BY PCB 6MM, BUT THERE WAS REMAINING STENOSIS. A 7.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS THEN ADVANCED FOR ADDITIONAL DILATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328684 ↗
• InjuryNov 16, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO DEFLATE. A 7.0MMX40MMX80CM STERLING BALLOON CATHETER WAS SELECTED FOR A PROCEDURE IN AN ARTERIOVENOUS SHUNT. THE STERLING WAS USED WITH A NON-BOSTON SCIENTIFIC 4FR SHEATH AND 0.018" GUIDEWIRE. BALLOON DILATATION WAS PERFORMED TWICE. DEFLATION WAS UNABLE TO BE PERFORMED WITH A DILATATION SYRINGE NOR A 20ML SYRINGE. ADDITIONAL DILATATION AND DEFLATION WAS ATTEMPTED WITHOUT SUCCESS. THE PROCESS WAS REPEATED USING ONLY SALINE VERSUS THE INITIAL HALF SALINE HALF CONTRAST MIXTURE WITHOUT SUCCESS. THE PATIENT WAS PUNCTURED AGAIN AND THE STERLING BALLOON CATHETER IN THE SHUNT WAS PIERCED FROM THE OUTSIDE WITH A CANNULA UNDER FLUOROSCOPY. THE SHEATH WAS REMOVED TOGETHER WITH THE BALLOON AND GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843907 ↗
• InjuryOct 23, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727835 ↗
• MalfunctionJul 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE UPPER ARM. A 7.0MMX40MMX80CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10299298 ↗