Athletis™ H74939347080870Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729974093), received between Jun 29, 2021 and Nov 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. AN 8.0MM X 80MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER 30 SECONDS OF INFLATION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554677 ↗
• MalfunctionJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. AN 8.0MM X 80MM X 75CM ATHLETIS WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON BURST JUST BEFORE THE PRESSURE WAS APPLIED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114311 ↗
• MalfunctionMay 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CENTRAL VESSEL. A 8.0MM X 80MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST JUST BEFORE THE OPERATING PRESSURE WAS REACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343637 ↗
• MalfunctionFeb 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR AN ARTERIOVENOUS GRAFT (AVG) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE TARGET LESION WAS 80% STENOSED. DURING THE FIRST INFLATION OF LESS THAN 10 SECONDS, THE BALLOON RUPTURED. AFTER DECOMPRESSION, THE DEVICE WAS ABLE TO BE 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 13600923 ↗
• MalfunctionJun 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED OVER A GUIDEWIRE TO DE-CLOT AN ATRIOVENTRICULAR HEMODIALYSIS ACCESS GRAFT. WHEN THE BALLOON WAS INFLATED TO DISRUPT THE INTERSTICES OF THE GRAFT IT RUPTURED AT 10 ATMOSPHERES. CONTRAST WAS SEEN LEAKING FROM THE BALLOON. THE BALLOON WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085489 ↗