EverCross™ AB35W10040135 (UDI 00643169974517)Recalls & reported problems
Ev3, Inc · PTA AB35W10040135 EVERCROSS 035 V08 · Class 2
All models of EverCross (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169974517), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON FOR TREATMENT FIBROUS VENOUS FISTULA. THERE WAS 85% STENOSIS WITH MODERATE TORTUOSITY AND NO CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCING DEVICE. IT WAS REPORTED THE BALLOON SEPARATED FROM THE CATHETER AND THE PHYSICIAN WAS ABLE TO RETRIEVE IT USING ULTRASOUND AND ANOTHER BALLOON.
Patient problems: Insufficient Information
MAUDE report 17247473 ↗
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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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