EverCross™ AB35W12060135Recalls & reported problems
Ev3, Inc · PTA AB35W12060135 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 00821684062340), received between Sep 6, 2019 and Sep 6, 2019 — 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.
MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A NON-MEDTRONIC 6FR SHEATH (COOK) AND A NON-MEDTRONIC 0.035' GUIDEWIRE (ABBOTT) TO TREAT A MODERATELY CALCIFIED LESION PRESENTING 70% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY. ARTERY DIAMETER AND LESION LENGTH WERE 5MM AND 10 MM, RESPECTIVELY. THE DEVICE WAS PREPPED PER THE IFU. A NON-MEDTRONIC INFLATION DEVICE (BOSTON) WAS USED TO INFLATE THE BALLOON. THE BALLOON DID NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT. IT WAS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED DURING FIRST BALLOON INFLATION AT 7 ATM. ANOTHER EVERCROSS BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8968862 ↗
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
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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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