Athletis™ H74939347051070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729973737), received between Nov 2, 2021 and Nov 24, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 5.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT SHUNT STENOSIS. THE TARGET AREA WAS 75% STENOSED, AND THE ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 6 ATMOSPHERES WHEN INFLATED FOR 10 SECONDS. A PINHOLE WAS LOCATED NEAR THE BALLOON TIP. THE DEVICE WAS REMOVED USING THE NORMAL METHOD WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 23639715 ↗
• MalfunctionSep 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED VESSEL. A 5.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE SECOND INFLATION. 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 23098204 ↗
• MalfunctionFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED INNER SHUNT. A 5.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON FIRST INFLATION AT 30 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER COMPLICATIONS OCCURRED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758500 ↗
• MalfunctionJan 31, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BRACHIAL VEIN. A 5.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS FIRST INFLATED AT 30 ATMOSPHERES FOR 30 SECONDS. HOWEVER, UPON DEFLATING THE BALLOON, IT COULD NOT DECOMPRESS. THE NEGATIVE PRESSURE WAS KEPT APPLIED AND WAS ACHIEVED IN ABOUT 1 MINUTE INSTEAD OF 15 SECONDS. THE BALLOON WAS REMOVED IN A DEFLATED STATE, AND THE PROCEDURE WAS COMPLETED WITH A 6.0MM X 100MM X 75CM ATHLETIS BALLOON. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618917 ↗
• MalfunctionOct 18, 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 SEVERELY CALCIFIED VESSEL. A 5.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 34 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THER WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962531 ↗
• MalfunctionJan 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERIOVENOUS FISTULA VEIN SIDE. A 5.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 40 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221769 ↗
• MalfunctionFeb 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. AN ATHLETES 5.0MM X 100MM X 75CM BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY ENDOVASCULAR THERAPY PROCEDURE. THE PROCEDURE WAS BEING PERFORMED TO TREAT 95% STENOSIS. THE TARGET LESION CONTAINED SEVERE CALCIFICATION AND MODERATE TORTUOUS SEVERITY. THE PHYSICIAN INSERTED THE CATHETER, AND UPON TREATMENT OF THE AREA THE BALLOON RUPTURED WITH A SINGLE INFLATION AT 30 ATM FOR 3 SECONDS. THE CATHETER WAS REMOVED AS INTENDED, AND SURGICAL OBSERVATIONS FOUND A PINHOLE NEAR THE MIDDLE OF THE BALLOON. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE WITHOUT SEQUELA. PATIENT WAS NOTED TO BE IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549431 ↗
• MalfunctionDec 2, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE BALLOON SHAFT BROKE. AN ATHLETICS 5.0MM X 100MM X 75CM WAS SELECTED FOR USE IN AN ENDOVASCULAR THERAPY PROCEDURE, TO TREAT PERIPHERAL ARTERY DISEASE, IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS MODERATELY TORTUOUS, 99% STENOSED, AND SEVERELY CALCIFIED. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE BALLOON SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS NOTED TO BE GOOD, WITH NO REPORTED COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915387 ↗
• MalfunctionNov 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS RUPTURED. A 5.00 MM X 100 MM X 75 CM ATHLETIS WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE SHUNT. PATIENT ANATOMY CONDITIONS REVEALED MODERATE TORTUOSITY AND 75% STENOSIS. THE BALLOON WAS INFLATED THREE TIMES, AT 30 ATMOSPHERES (ATM), FOR 60 SECONDS EACH. THE BALLOON RUPTURED AT 30 ATM WHILE INSIDE THE PATIENT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737975 ↗