EverCross™ AB35W08020080 (UDI 00763000184742)Recalls & reported problems
Ev3, Inc · PTA AB35W08020080 EVERCROSS 035 V09 · 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 00763000184742), received between Nov 13, 2022 and Nov 13, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2022Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
A PHYSICIAN WAS USING AN EVERCROSS BALLOON. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AND A CONTRAST/HEP SALINE MIX. IT WAS REPORTED THE PATIENT HAD A STUBBORN LESION AND THE PHYSICIAN INFLATED THE BALLOON TO 26ATM (THE PHYSICIAN WAS AWARE IT WAS GREATER THAN THE RBP). A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AND THE PHYSICIAN HAD DIFFICULTY REMOVING THE BALLOON. A PIECE OF CATHETER DETACHED AND THE PHYSICIAN HAD NO OTHER OPTION BUT TO CREATE AN INCISION AND REMOVE THE DETACHED PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786144 ↗
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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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