EverCross™ AB35W12020135Recalls & reported problems
Medtronic, Inc. · PTA AB35W12020135 EVERCROSS 035 V10 · Class 2
All models of EverCross (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000767181), received between Mar 11, 2026 and Mar 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Leak/Splash
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 DEVICE, A LEAK WAS IDENTIFIED AT THE SHAFT OF THE DEVICE. THE PATIENT WAS BEING TREATED FOR A VASCULAR LESION REQUIRING ANGIOPLASTY. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE ISSUE WAS REPORTED AGAINST 2 EVERCROSS DEVICES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566835 ↗MalfunctionMar 11, 2026Leak/Splash
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE EVERCROSS 035 DEVICE, A LEAK WAS IDENTIFIED AT THE SHAFT OF THE DEVICE. THE PATIENT WAS BEING TREATED FOR A VASCULAR LESION REQUIRING ANGIOPLASTY. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE ISSUE WAS REPORTED AGAINST 2 EVERCROSS DEVICES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566820 ↗
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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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