Athletis™ H74939347050410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729973652), received between Dec 1, 2023 and Oct 8, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED VESSEL. A 5.0MM X 40MM X 135CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WITHIN RATED BURST PRESSURE REQUIREMENTS. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT WITHOUT ANY PIECES REMAINED INSIDE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ATHLETIS BALLOON. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20399733 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL TRAUMA OCCURRED. THE PATIENT UNDERWENT AN ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 5.0MM X 40MM X 135CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, INFLATION OF THE ATHLETIS BALLOON LEAD TO A RUPTURE OF THE SUBCLAVIAN ARTERY WHICH WAS THEN TREATED WITH A COVERED STENT. THE DEVICE WAS REMOVED AND REPLACED FOR A DIFFERENT MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 19230562 ↗
• MalfunctionDec 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT TREATMENT FOR ARTERIAL STENOSIS WITH A 5.0MM X 40MM X 135CM ATHLETIS BALLOON CATHETER. THE BALLOON WAS ADVANCED FOR DILATION IN A SEVERELY CALCIFIED LESION. IT WAS DURING THE FIRST INFLATION AS PER THE RECOMMENDED ATMOSPHERES WHEN 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246801 ↗