Athletis™ H74939347060470Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729973799), received between May 24, 2021 and Aug 12, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225927 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED UPPER ARM SHUNT. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD 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 PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882490 ↗
• MalfunctionApr 17, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT BALLOON BECAME STUCK WITH THE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE BALLOON BECAME STUCK WITH 150CM NON-BOSTON SCIENTIFIC GUIDEWIRE. THE DEVICE WAS REMOVED, BUT IT WAS CONSIDERABLY DIFFICULT. BOTH THE BALLOON AND WIRE WERE REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861809 ↗
• MalfunctionNov 13, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA OF BRACHIAL ARTERY. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON BURST AND LEAKED CONTRAST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678939 ↗
• MalfunctionSep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON FEMORAL ARTERY (CFA). A 6.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, 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 20224644 ↗
• MalfunctionApr 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FOREARM VESSEL. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 40 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 19197597 ↗
• MalfunctionApr 4, 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 BRACHIAL VEIN. A 6.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON TWELVE INFLATIONS AT 30 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 19047217 ↗
• MalfunctionMar 26, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH WIRE. THE 90% STENOSED TARGET LESIONS WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE FOREARM. A 6.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BECAME STUCK WITH A 0.035 NON-BOSTON SCIENTIFIC GUIDEWIRE. THE GUIDEWIRE WAS REMOVED FROM THE CATHETER OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981986 ↗
• MalfunctionFeb 26, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 6.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE DILATING THE BALLOON USING THE INFLATOR, THE CENTER PART OF THE BALLOON BURST, AND THE CONTRAST AGENT LEAKED OUT WITHOUT DILATATION. AFTER SEVERAL ATTEMPTS TO DILATE, THE CONTRAST AGENT CONTINUED TO LEAK OUT AND THE BALLOON WAS NOT DILATED. 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 18779996 ↗
• MalfunctionAug 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL FOREARM. A 6.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 40 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL 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 17568531 ↗
• MalfunctionApr 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON DILATATION CATHETER WAS ADVANCED. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED AND WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED. THE BALLOON WAS INFLATED TWICE BEFORE IT RUPTURED AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16739881 ↗
• MalfunctionNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 6.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR THE VASCULAR ACCESS INTERVENTIONAL THERAPY CASE. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 10 SECONDS DURATION TIME, THE BALLOON RUPTURED. THE DEVICE WAS ABLE TO BE REMOVED USING THE NORMAL METHOD WITHOUT ANY ISSUES. ANOTHER ATHLETIS BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729833 ↗
• MalfunctionDec 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN A SHUNT. PATIENT ANATOMY CONDITIONS REVEALED 99% STENOSIS, MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE BALLOON WAS INFLATED THREE TIMES BELOW 32 ATMOSPHERES (ATMS) FOR 30 SECONDS. ON THE THIRD INFLATION, THE BALLOON RUPTURED WHEN INFLATED TO 32ATMS. THE BALLOON WAS COMPLETELY REMOVED 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 13042442 ↗
• MalfunctionMay 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). STENOSIS WAS ESTIMATED AT 50% TARGET LESION WAS 80% CALCIFIED WITH NO TORTUOSITY. A 6.0MM X 40MM X 75CM ATHLETIS BALLOON WAS SELECTED FOR USE IN A SFA ANGIOPLASTY PROCEDURE TO POST-DILATE A STENT. AFTER THE STENT WAS IMPLANTED, THE ATHLETIS BALLOON WAS INFLATED ONCE TO A PRESSURE BETWEEN 10-12 ATMOSPHERES. HOWEVER, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH RECANALIZATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873371 ↗