Athletis™ H74939347051050Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729973720), received between Nov 3, 2021 and Mar 3, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED NEAR THE CEPHALIC VEIN ANASTOMOSIS. A 5.0MM X 100MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509846 ↗
• MalfunctionFeb 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MM X 100MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 35 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME 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 21356531 ↗
• MalfunctionSep 13, 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 SHUNT VEIN. A 5.0MM X 100MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 20212403 ↗
• MalfunctionAug 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM. A 5.0MM X 100MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT ABOUT 30 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED. THE RUPTURE WAS FOUND TO BE IN THE SHAPE OF A PINHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951748 ↗
• MalfunctionJul 24, 2023Material 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 VEIN. A 5.0MM X 100MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 10 SECONDS, 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 REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381618 ↗
• MalfunctionJul 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 TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 5.0MM X 100MM X 50CM ATHLETIS PTA BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INITIAL INFLATION AT 34 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 POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367088 ↗
• MalfunctionMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 5.0MM X 100MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING THE INITIAL INFLATION AT 30 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857964 ↗
• MalfunctionNov 30, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07NOV2022. AN ATHLETIS 5.0MM X 100MM X 50CM WAS SELECTED FOR USE IN THE DIALYSIS SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE PATIENT ANATOMY WAS REPORTED TO BE SEVERELY CALCIFIED. DURING THE PROCEDURE, THE ATHLETIS WAS ADVANCED TO THE TARGET LESION, AND UPON INITIAL DILATION, CONTRAST WAS OBSERVED TO BE LEAKING FROM THE DEVICE. THERE WAS NO VISIBLE DAMAGE TO THE BALLOON. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE ATHLETIS WAS RETURNED FOR INVESTIGATION. DEVICE ANALYSIS REVEALED A PINHOLE RUPTURE ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890711 ↗
• MalfunctionNov 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS SHUNT. A 5.0MM X 100MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR THE SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON RUPTURED. THE BALLOON WAS ABLE TO BE REMOVED USING THE NORMAL METHOD, AND IT WAS REPLACED WITH ANOTHER ATHLETIS DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789292 ↗
• InjuryMay 23, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Stretched; Material Integrity Problem; Deflation Problem; Inflation Problem; Difficult to Remove; Stretched; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED/DIFFICULT TO REMOVE. AN ATHLETIS 5.0MM X 100MM X 50CM BALLOON DILATATION CATHETER WAS SELECTED FOR A DIALYSIS SHUNT TREATMENT IN THE FOREARM/UPPER ARM USING ARTERIOVENOUS FISTULA THROMBECTOMY PROCEDURE. THE PROCEDURE WAS BEING PERFORMED TO TREAT 100% STENOSIS, AND THE TARGET LESION CONTAINED MODERATE TORTUOUS SEVERITY. THE LESION WAS DILATED USING THE ATHLETIS, AND THE THROMBUS WAS REMOVED. NEGATIVE PRESSURE WAS THEN APPLIED FOR ONE MINUTE AND THE INFLATION LUMEN WAS FLAT, BUT BALLOON COULD NOT BE DEFLATED OR REMOVED FROM THE SHEATH. WHEN IT WAS PULLED FORCIBLY WITH THE GUIDEWIRE BEING REMOVED, THE SHAFT GOT EXTENDED. THE BLOOD VESSEL WAS ALREADY OPENED DURING THROMBECTOMY, SO THE BALLOON SHAFT WAS CUT AND THE BALLOON TIP WAS GRASPED USING A TOOL. IT WAS PULLED TO THE OPPOSITE SIDE OF THE SHEATH, AND THEY WERE ABLE TO SUCCESSFULLY REMOVE STUCK DEVICE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER ATHLETIS DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14477769 ↗
• MalfunctionMar 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0MM X 100MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR THE SHUNT PERCUTANEOUS ANGIOPLASTY PROCEDURE IN THE 90% STENOSED AND MODERATELY CALCIFIED TARGET LESION. DURING THE FIRST INFLATION OF 1 ATMOSPHERE FOR 3 SECONDS, THE BALLOON RUPTURED VERTICALLY. IT WAS NOTED THAT THE BALLOON MAY HAVE RUPTURED FROM THE BEGINNING. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908632 ↗
• MalfunctionNov 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED. A 5.0MM X 100MM X 50CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE (PTA). THE TARGET LESION WAS 90% STENOSED WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. WHEN THE DEVICE WAS INFLATED, IT RUPTURED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748970 ↗