Athletis™ H74939347120470Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729974260), received between Jun 10, 2021 and Aug 17, 2026 — classified as 20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273301 ↗
• MalfunctionAug 13, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244657 ↗
• MalfunctionDec 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE OF AN ARTERIOVENOUS FISTULA. INSIDE THE PATIENT, DURING INFLATION OF THE BALLOON AT 8 ATMOSPHERES, THE BALLOON BURST. 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 23768787 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Leak/Splash; Material Rupture; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Leak/Splash; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE IN AN ARTERIOVENOUS FISTULA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING THIRD INFLATION AT NOMINAL ATMOSPHERES, THE BALLOON RUPTURED. CONTRAST LEAKAGE WAS CONFIRMED, AND THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310869 ↗
• MalfunctionSep 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A CENTRAL LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT A BALLOON RUPTURE OCCURRED JUST BEFORE REACHING THE PRESSURE. 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 23048242 ↗
• MalfunctionSep 11, 2025Material 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. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED JUST BEFORE REACHING THE PRESSURE. THE PROCEDURE CONTINUED WITHOUT ANY ISSUES USING THE SAME PRODUCT. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032223 ↗
• MalfunctionMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD TO FOURTH INFLATION AT 26 ATMOSPHERES FOR 2 MINUTES. 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 22014107 ↗
• MalfunctionFeb 18, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGE WAS OPENED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE TOP PART OF THE STERILE PACKAGING WAS OPENED. THE DEVICE GOT COMPROMISED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404752 ↗
• MalfunctionJan 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 21164035 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON BURST JUST BEFORE REACHING THE PRESSURE. 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 21143633 ↗
• MalfunctionDec 18, 2024Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT CROSSING DIFFICULTY AND BALLOON TEAR OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE CENTRAL VEIN LESIONS. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE COULD NOT CROSS THE PREVIOUSLY PLACED STENT AND THE BALLOON WAS TORN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20967214 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING PRESSURE. 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 19361460 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING THE RATE BURST PRESSURE. THERE WERE NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360982 ↗
• MalfunctionMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, BEFORE THE BALLOON REACHED MEDIUM PRESSURE, IT RUPTURED. THE DEVICE WAS TAKEN OUT AND THE PATIENT WAS RE-TREATED FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ABNORMALITIES OR PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353979 ↗
• MalfunctionApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT BALLOON RUPTURED BEFORE REACHING RATED BURST PRESSURE. 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 19046319 ↗
• MalfunctionMar 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON BURST JUST BEFORE REACHING PRESSURE. THE SAME PRODUCT WAS THEN USED FOR RETREATMENT WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877813 ↗
• MalfunctionAug 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND STENT EXPANSION FAILURE OCCURRED. THE PATIENT EXPERIENCED MAY THURNER SYNDROME. THE 59% STENOSED TARGET LESION WITH AROUND 5MM DIAMETER WAS LOCATED IN THE MILDLY TORTUOUS AND COMPRESSED CALCIFIED DISTAL EXTERNAL ILIAC VEIN. A 16X4X75 XXL ESOPHAGEAL BALLOON CATHETER WAS USED TO EXPAND THE WALLSTENT IN THE COMMON AND EXTERNAL ILIAC VEIN. THE STENT WAS FULLY RE-CONSTRAINED; HOWEVER, THE WALLSTENT DID NOT EXPAND SUFFICIENTLY AND IN ADDITION, A 12.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS USED. BUT DURING SECOND INFLATION AT 8 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME ATHLETIS BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645712 ↗
• MalfunctionMay 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING INFLATION, THE BALLOON BURST 12 ATMOSPHERES BEFORE REACHING THE RATED BURST PRESSURE AT 20 ATMOSPHERES. 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 16918432 ↗
• MalfunctionApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RADIAL ARTERIOVENOUS FISTULA. A 12.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 23 ATMOSPHERES IN 20 SECONDS, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728003 ↗
• MalfunctionJun 10, 2021Material Rupture; Device-Device Incompatibility; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 12X40X75 ATHLETIS PTA BALLOON WAS SELECTED FOR USE IN A DEEP VENOUS STENTING PROCEDURE. THE ATHLETIS BALLOON WAS SUCCESSFULLY USED THREE TIMES TO PRE-DILATE BEFORE STENTING. AFTER PLACEMENT OF A WALLSTENT, THE ATHLETIS WAS USED FOR POST-DILATION. DURING INFLATION THE BALLOON RUPTURED ON THE EDGE OF THE IMPLANTED STENT. A NON-BSC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977796 ↗