Athletis™ H74939347061070Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729973850), received between Aug 10, 2021 and Apr 7, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RADIAL ANTECUBITAL VEIN. A 6.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION AT 30 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809090 ↗
• MalfunctionDec 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED VEIN. A 6.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED AT THE MIDDLE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879923 ↗
• MalfunctionOct 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED VESSEL BRACHIAL VEIN. A 6.0MM X 100MM X 75CM ATHLETICS BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT EXCEEDED NOMINAL PRESSURE FOR NEARLY 20 SECONDS. 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 23348010 ↗
• MalfunctionJul 16, 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 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION, 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 22520766 ↗
• MalfunctionMay 28, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE GUIDEWIRE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SHUNT OF THE UPPER ARM. A 6.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE DEVICE BECAME STUCK WITH THE GUIDEWIRE. THE CATHETER AND THE GUIDEWIRE WERE REMOVED SEPARATELY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100998 ↗
• MalfunctionNov 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 6.0MM X 100MM X 75CM ATHLETICS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 10 ATMOSPHERES FOR 15 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 20679368 ↗
• MalfunctionJul 3, 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 VESSEL VEIN. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS. 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 19667929 ↗
• MalfunctionApr 18, 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 VESSEL. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 30 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135935 ↗
• MalfunctionApr 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATM FOR 10 SECONDS. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE 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 19036360 ↗
• MalfunctionMar 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS VESSEL. A 6.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 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 18959600 ↗
• MalfunctionMar 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 VESSEL. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER. UPON FIRST INFLATION AT 35 ATMOSPHERES FOR 40 SECONDS THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895771 ↗
• MalfunctionFeb 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714628 ↗
• MalfunctionJun 26, 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 VESSEL. A 6.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 30 ATMOSPHERES FOR 30 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 17204213 ↗
• MalfunctionApr 27, 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 VEIN. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 34 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824612 ↗
• MalfunctionJun 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS ANATOMY. A 6.0MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION DURING THE VASCULAR ACCESS INTERVENTION THERAPY PROCEDURE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 15 SECONDS INFLATION TIME. AFTER DECOMPRESSION, THE DEVICE WAS REMOVED FROM THE BODY AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599413 ↗
• MalfunctionOct 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. AN ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED AND INFLATED SEVERAL TIMES TO THE RATED BURST PRESSURE OR LOWER. THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH A NEW ATHLETIS PTA BALLOON DILATATION CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662389 ↗
• MalfunctionAug 10, 2021Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. A 6MM X 100MM ATHLETIS BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE 75% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS ANATOMY. THE PLAN WAS TO PLACE A NON-BOSTON SCIENTIFIC STENT. PRE-DILATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND THE ATHLETIS BALLOON. THE GUIDEWIRE WAS THEN REMOVED WITH THE ATHLETIS LEFT IN PLACE. AN ATTEMPT WAS MADE TO INSERT A DIFFERENT NON-BOSTON SCIENTIFIC GUIDEWIRE, BUT THERE WAS RESISTANCE IN THE MIDDLE, AND IT COULD NOT BE INSERTED. THE GUIDEWIRE WAS EXCHANGED FOR ANOTHER, BUT THERE WAS STRONG RESISTANCE IN THE SAME LOCATION, AND IT COULD NOT BE INSERTED. AN ATTEMPT WAS THEN MADE TO INSERT THE ORIGINAL GUIDEWIRE, BUT RESISTANCE WAS FELT AT THE SAME LOCATION, AND IT COULD NOT BE INSERTED. THE ATHLETIS WAS REMOVED. WHEN IT WAS FLUSHED, A BLUE RESIDUE CAME OUT. TARGET TREATMENT WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302076 ↗