EverCross™ AB35W05200080Recalls & reported problems
Ev3, Inc · PTA AB35W05200080 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 00643169973787), received between May 24, 2023 and May 24, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2023Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERCROSS TO TREAT A CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS MODERATE. THE VESSEL WAS PRE-DILATED. EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED WITH A SYRINGE. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGHA PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THERE WERE NO ISSUES DURING INFLATION. NO DAMAGE NOTED TO THE BALLOON CATHETER. IT IS REPORTED THAT THERE WAS BALLOON DEFLATION DIFFICULTIES AND REMOVAL. DEVICE WOULD NOT DEFLATE AT THE LESION SITE AND THERE WAS DIFFICULTY REMOVING BALLOON. FLOW WAS IMPEDED IN VESSEL. THE PATIENT HAD TO HAVE SURGERY TO REMOVE PART OF THE BALLOON THAT GOT STUCK IN THE VESSEL AND IS DUE TO HAVE FURTHER SURGERY TO REMOVE RADIOPAQUE MARKER FROM THE SUPERFICIAL FEMORAL ARTERY. VESSEL OCCLUSION DUE TO THE DEVICE COMPONENT AND VESSEL SPASM WERE REPORTED.
Patient problems: Obstruction/Occlusion
MAUDE report 16990598 ↗
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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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