EverCross™ AB35W10060080 (UDI 00763000767150)Recalls & reported problems
Medtronic, Inc. · PTA AB35W10060080 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 00763000767150), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- 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.
MalfunctionFeb 13, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING THE EVERCROSS 035 A BALLOON DILATATION DEVICE, THE BALLOON GOT STUCK OUTSIDE OF THE 7F SHEATH AND SUBSEQUENTLY RIPPED APART INTO THREE PIECES. THE PROCEDURE WAS BEING PERFORMED AT THE AV ACCESS SITE IN THE RIGHT PROXIMAL VEIN. A 7F SHEATH WAS USED. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST WAS USED. THE BALLOON DETACHED WITHIN THE VESSEL, CAUSING REMOVAL DIFFICULTIES. THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS REMOVED IN TANDEM WITHOUT INJURY OR INTERVENTION. POST PROCEDURE THE BALLOON WAS DESTROYED. THE SURGERY EXPERIENCED A 15-MINUTE DELAY DUE TO THESE ISSUES. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO MEDICATION ADMINISTERED TO THE PATIENT OR ADDITIONAL INTERVENTION REQUIRED IN REMOVING THE DETACHED BALLOON. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374544 ↗
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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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