EverCross™ AB35W09040080 (UDI 00763000767037)Recalls & reported problems
Medtronic, Inc. · PTA AB35W09040080 EVERCROSS 035 V10 · Class 2
All models of EverCross (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000767037), received between Aug 18, 2026 and Aug 18, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
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.
MalfunctionAug 18, 2026Burst Container or Vessel
It was reported during a procedure using an Evercross PTA balloon catheter for the treatment of a plaque lesion in the distal section of the right and left artery of the distal aorta, the balloon burst "Balloon Burst AT, BELOW, or UNKNOWN Rated Burst Pressure", sp ecifically, a pin hole, which occurred on the first inflation. A 6x45 (Terumo) Destination Sheath was used. Embolic protection was not used. The vessel was not pre or post dilated. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. The balloon was inflated with an inflation device and 50/50 contrast was used. No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray. The instructions for use were followed without issue. It is not known at what pressure the balloon burst. The balloon did not detach during the event. The device was safely removed from the patient and the procedure was aborted. The patient was reported as alive, with no injury. No health consequences or impact were reported as a result of this event. There was no injury or intervention associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50297095 ↗
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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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