Athletis™ H74939347100870Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729974222), received between Mar 13, 2024 and Nov 27, 2025 — classified as 3 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 16, 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.

• MalfunctionNov 27, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11NOV2025. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. A 10.0MM X 80MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE PRESSURE DROPPED JUST BEFORE REACHING THE PRESSURE LEVEL. THE PROCEDURE WAS RESUMED WITH THE SAME DEVICE WITHOUT ANY ISSUES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE LOCATED APPROXIMATELY 4MM PROXIMAL FROM THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23668452 ↗
• MalfunctionOct 15, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 10.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS. THE DEVICE WAS DEFLATED AND WAS REMOVED. NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. 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 20456656 ↗
• MalfunctionMar 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. A 10.0MM X 80MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST JUST BEFORE THE WORKING PRESSURE WAS REACHED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895949 ↗