Athletis™ H74939347060450Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729973782), received between Jun 10, 2022 and Jul 6, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM SHUNT VEIN SIDE. A 6.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 15 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 25728052 ↗
• MalfunctionOct 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT CEPHALIC VEIN. A 6.0 MM X 40 MM X 50 CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 35 ATMOSPHERES FOR 10 SECONDS. 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 23425212 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE WAS NOTED. A 6.0MM X 40MM X 50CM ATHLETIS WAS ADVANCED FOR DILATION. HOWEVER, DESPITE PRESSURIZATION UP TO 40 ATMOSPHERES, THE STENOSIS COULD NOT BE RESOLVED. CONSEQUENTLY, A BALLOON PINHOLE WAS NOTED. 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 23303894 ↗
• MalfunctionMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CEPHALIC VEIN OF THE FOREARM. A 6.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 30 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014306 ↗
• MalfunctionApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED SHUNT WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 6.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117019 ↗
• MalfunctionJan 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN. A 6.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION AT 30 ATMOSPHERES FOR 10 SECONDS THE BALLOON RUPTURED IN THE MIDDLE PART. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566122 ↗
• MalfunctionJan 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 6.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH 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 18553223 ↗
• MalfunctionNov 1, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM. A 6.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED. THE BALLOON WAS INFLATED TWICE AT 40 ATMOSPHERES FOR 1 MINUTE WITH NO APPARENT ISSUE. THE BALLOON WAS DEFLATED BUT WITH NO SUCCESS. THE DEVICE WAS UNABLE TO BE REMOVED AND RESISTANCE WAS FELT. SUBSEQUENTLY, THE DEVICE WAS REMOVED TOGETHER WITH THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048272 ↗
• MalfunctionSep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CEPHALIC VEIN OF THE FOREARM. A 6.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FOURTH INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED ENTIRELY IN A VERTICAL FORM. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684018 ↗
• MalfunctionFeb 6, 2023Leak/Splash; Material Rupture; Material Integrity Problem; Leak/Splash; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR VASCULAR ACCESS INTERVENTION THERAPY. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN. A 6.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 25 ATMOSPHERES, THE BALLOON RUPTURED. ADDITIONALLY, A CRACK IN THE INFLATION LUMEN OF THE HUB WAS OBSERVED FROM WHICH PRESSURE WAS THOUGHT TO HAVE LEAKED. 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 16303243 ↗
• MalfunctionJan 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS ULNAR VEIN. A 6.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 25 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214155 ↗
• MalfunctionOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. AN ATHLETIS 6.0MM X 40MM X 50CM BALLOON DILATATION CATHETER WAS SELECTED FOR USE FOR SHUNT STENOSIS IN THE FOREARM CEPHALIC VEIN FOR VASCULAR ACCESS INTERVENTION THERAPY (VAIVT). THE PROCEDURE WAS BEING PERFORMED TO TREAT 90% STENOSIS. THE TARGET LESION CONTAINED MODERATE CALCIFICATION AND NO TORTUOUS SEVERITY. THE PHYSICIAN INSERTED THE CATHETER, AND UPON THE SECOND TREATMENT OF THE AREA THE BALLOON RUPTURED AFTER INFLATION AT 20 ATM FOR 30 SECONDS. THE CATHETER WAS REMOVED AS INTENDED, AND SURGICAL OBSERVATIONS FOUND A VERTICAL RUPTURE IN THE BALLOON. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667769 ↗
• MalfunctionJun 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR THE SHUNT PERCUTANEOUS ANGIOPLASTY (PTA) PROCEDURE. DURING THE FIRST INFLATION, HOWEVER, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657862 ↗