EverCross™ AB35W05060135 (UDI 00821684061428)Recalls & reported problems
Ev3, Inc · PTA AB35W05060135 EVERCROSS 035 V05 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684061428), received between Aug 8, 2018 and Aug 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 other recall cover devices cleared under the same FDA submission (K103322); they may or may not involve this specific model.
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
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2018Burst Container or Vessel
IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS BALLOON TO TREAT A SOFT TISSUE LESION (80% STENOSIS) IN THE MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS REPORTED TO BE NON TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ADVANCING THE DEVICE, IT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT <(>&<)> NO EXCESSIVE FORCE WAS USED. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC DEVICE. DURING THE SECOND BALLOON INFLATION THE DEVICE BURST AT 10 ATM. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY OPENING A NEW 5X60 BALLOON. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7762031 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103322. One submission often covers many models, so check the product and lot details in each record.
- Z-1489-2014 · Apr 9, 2014 · Terminatedev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W
Other Catheter, angioplasty, peripheral, transluminal devices
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- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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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