Athletis™ H74939347090870Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Athletis (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729974185), received between Mar 28, 2024 and Jul 14, 2025 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 9.0MM X 80MM X 75CM ATHLETIS DEVICE WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND-THIRD INFLATION AROUND THE MAXIMUM PRESSURE FOR ABOUT 30 SECONDS, THE BALLOON RUPTURED. 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 22500839 ↗MalfunctionMar 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 9.0MM X 80MM X 75CM ATHLETIS PTA BALLOON WAS ADVANCED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. 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 18995272 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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