Athletis™ H74939347080450Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729974048), received between Aug 26, 2021 and Nov 24, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PINHOLE NOTED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED UPPER ARM CEPHALIC VEIN. AN 8.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, PINHOLE DAMAGE WAS NOTED ON THE SHAFT. 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 23632627 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN UPPER ARM. A 8.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION, THE BALLOON RUPTURED. 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. IT WAS FURTHER REPORTED THAT THE PATIENT'S ANATOMY WAS CHALLENGING, POSSIBLY DUE TO CALCIFICATION. THE BALLOON WAS INFLATED TO 20 ATMOSPHERES, BUT THE RUPTURE OCCURRED ON THE SECOND INFLATION, FOR WHICH THE NOMINAL PRESSURE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567480 ↗
• MalfunctionMay 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC ARCH. AN 8.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 25 ATMOSPHERES FOR SEVERAL SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 22106271 ↗
• MalfunctionOct 14, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material 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 MILDLY CALCIFIED CEPHALIC ARCH. AN 8.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 18 ATMOSPHERES FOR FEW 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 20444505 ↗
• MalfunctionMar 27, 2024Material Rupture; Device-Device Incompatibility; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED WHILE INTERACTING WITH ANOTHER DEVICE. THE PATIENT UNDERWENT A VASCULAR ACCESS INTERVENTION THERAPY FOR A RESTENOSIS OF A WALLSTENT RP IMPLANTED AT ANOTHER FACILITY SEVERAL YEARS AGO. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC ARCH. A 8.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. AT THE TIME THE DEVICE WAS ON ONGOING USE, THE BALLOON RUPTURED. IT IS POSSIBLE THAT THIS WAS CAUSED BY THE SHARP STENT EDGE OF THE IMPLANTED WALLSTENT. THE DEVICE WAS REMOVED AND REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987580 ↗
• MalfunctionMar 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 8.00MM X 40MM X 50CM ATHLETIS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATION CATHETER WAS SELECTED FOR THE TREATMENT OF A SHUNT FAILURE IN THE CEPHALIC SUBCLAVIAN VEIN. THE LESION WAS LOCATED IN A MODERATELY TORTUOUS ANATOMY, 75% STENOSED AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TWICE TO 20 ATMOSPHERES (ATMS). DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS USING THE NORMAL METHOD. 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 13945608 ↗
• MalfunctionDec 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BALLOON RUPTURED. AN 8.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS USED TO TREAT A PREVIOUSLY PLACED WALLSTENT IN THE CEPHALIC VEIN THAT WAS 75% STENOSED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED. THE ATHLETIS BALLOON WAS ADVANCED TO THE TARGET LESION, INFLATED TWICE TO 25ATM FOR 20 SECONDS EACH. ON THE SECOND INFLATION THE BALLOON RUPTURED, AND WAS NOTED TO BE THE SHAPE OF A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ATHLETIS BALLOON. THE PATIENT WAS REPORTED IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12950606 ↗
• MalfunctionNov 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BALLOON RUPTURED. AN 8.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS USED TO TREAT A PREVIOUSLY PLACED WALLSTENT IN THE CEPHALIC VEIN THAT WAS 75% STENOSED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED. THE ATHLETIS BALLOON WAS ADVANCED TO THE TARGET LESION, INFLATED TO 12ATM, RUPTURED, AND WAS NOTED TO BE THE SHAPE OF A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ATHLETIS BALLOON. THE PATIENT WAS REPORTED IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900796 ↗
• MalfunctionOct 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 8.0MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR A PATIENT PROCEDURE IN THE SUBCLAVIAN VEIN TO TREAT THE PATIENT'S SHUNT FAILURE AND ALSO IN STENT RESTENOSIS. THE LESION WAS MODERATELY TORTUOUS AND 75% STENOSED. DURING THE PROCEDURE, INSIDE OF THE PATIENT, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 15 ATM. THE SHAPE OF THE RUPTURE WAS A PINHOLE RUPTURE. THE DEVICE WAS REMOVED FROM THE PATIENT USING NORMAL METHODS AND WITHOUT ANY PROBLEMS. NO ADDITIONAL DAMAGE WAS NOTED ON THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS GOOD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563060 ↗
• MalfunctionAug 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. AN 8MM X 40MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN THE BASILIC VEIN. THE 90% STENOSED TARGET LESION WAS NOT CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. DURING THE PROCEDURE, A PINHOLE RUPTURE OCCURRED WHEN ATTEMPTING TO REMOVE THE DEVICE. 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 12369786 ↗