Athletis™ H74939347081070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729974116), received between Mar 5, 2021 and Jan 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. AN ATHLETIS 8.0MM X 100MM X 75CM PTA BALLOON DILATION CATHETER WAS SELECTED FOR USE IN AN ARTERIOVENOUS (AV) FISTULAGRAM PROCEDURE FOR TREATMENT OF THE 75% VENOUS STENOSIS. THE BALLOON WAS MOVED TO THE STENOSIS AND INFLATED, THE BALLOON IMMEDIATELY HAD HIGH ATMOSPHERIC PRESSURE INSTEAD OF A GRADUAL INCREASE. THE BALLOON FULLY INFLATED FOR 30 SECONDS, BUT WOULD NOT DEFLATE. THE BALLOON DEFLATED ENOUGH TO REMOVE IT FROM THE SHEATH AFTER MULTIPLE INFLATION AND DEFLATION ATTEMPTS WERE MADE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE THE ENTIRE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239887 ↗
• MalfunctionDec 15, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. AN ATHLETIS 8.0MM X 100MM X 75CM PTA BALLOON DILATION CATHETER WAS SELECTED FOR USE IN AN ARTERIOVENOUS (AV) FISTULAGRAM PROCEDURE FOR TREATMENT OF VENOUS STENOSIS. THE PHYSICIAN INDICATED THAT AFTER COMPLETION OF THE ANGIOPLASTY, THE BALLOON WOULD NOT DEFLATE EVEN AFTER MULTIPLE ATTEMPTS USING A LARGE SYRINGE AND THE INFLATION DEVICE. THE SHEATH WAS REMOVED, AND THE INFLATED BALLOON WAS RETRACTED THROUGH THE SKIN AT THE ACCESS SITE. THE PATIENT EXPERIENCED PAIN AT THE ACCESS SITE UPON REMOVAL OF THE BALLOON, AND ANESTHESIA WAS USED FOR PAIN INTERVENTION. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: Pain

  MAUDE report 13010136 ↗
• MalfunctionMar 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. AN 8MM X 100MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN AN ARTERIOVENOUS (AV) GRAFT. THE TARGET LESION WAS 70% STENOSED WITH NO CALCIFICATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED FOR ONE MINUTE. ON THE SECOND INFLATION, THE BALLOON DEFLATED ALMOST IMMEDIATELY BEFORE REACHING 20ATM. THE BALLOON WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE FIRST INFLATION WAS AT ABOUT 10 TO 15 ATMOSPHERES (ATM), TO CREATE A PASSAGE. DURING THE SECOND INFLATION AT THE TREATMENT SITE, THE BALLOON REACHED ABOUT 19 ATM. THE PHYSICIAN LOCKED AND SET THE INFLATION DEVICE DOWN AND THE BALLOON DEFLATED IMMEDIATELY AND QUICKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423179 ↗