Athletis™ H74939347090470Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Athletis (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729974161), received between Dec 14, 2022 and Oct 15, 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Adverse Event Without Identified Device or Use Problem1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 9.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303449 ↗MalfunctionMay 6, 2024Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-APR-20234 IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. A 9.0MM X 40MM X 75CM ATHLETICS PTA BALLOON DILATATION CATHETER WAS ADVANCE FOR IN DILATION. DURING THE PROCEDURE, THE BALLOON LOST PRESSURE BEFORE REACHING RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19248863 ↗MalfunctionDec 14, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN THE RADIAL VEIN SIDE. A 9.0MM X 40MM X 75CM ATHLETIS PTA BALLOON DILATATION CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15978290 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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