Athletis™ H74939347071070Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729973973), received between Sep 4, 2024 and Jul 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Inflation Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JUN2025. IT WAS REPORTED THAT BALLOON DID NOT INFLATE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN RADIAL. A 7.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING FIRST INFLATION AT AROUND 20 ATMOSPHERES, THE BALLOON DID NOT INFLATE EVENLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566791 ↗InjurySep 4, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT A METAL MATERIAL WAS PROTRUDING FROM THE BALLOON. THE TARGET LESION WAS LOCATED IN THE FOREARM. A 7.0MM X 100MM X 75CM ATHLETIS BALLOON CATHETER WAS SELECTED FOR USE IN AN ANGIOPLASTY PROCEDURE OF AN ARTERIOVENOUS FISTULA. DURING THE PROCEDURE WHEN THE BALLOON WAS MOVING INSIDE THE PATIENT, A METAL WIRE APPEARED ON THE DISTAL PART OF THE SHAFT AND RESULTED IN A DISSECTION. THE DEVICE WAS REMOVED, HOWEVER, IT COULD NOT BE REINSERTED BACK INTO THE INTRODUCER SHEATH. IT WAS REPLACED FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE.
Patient problems: Vascular Dissection
MAUDE report 20135216 ↗
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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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