EverCross™ AB35W10060080 (UDI 00821684062272)Recalls & reported problems
Ev3, Inc · PTA AB35W10060080 EVERCROSS 035 V05 · Class 2
- 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 00821684062272), received between Feb 26, 2019 and Feb 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionFeb 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN WAS USING AN EVERCROSS TO TREAT A 60MM FIBROUS LESION WITH 80% STENOSIS IN THE LEFT MID SUBCLAVIAN VEIN. MODERATE TORTUOSITY WAS REPORTED AND THE DIAMETER OF THE VEIN WAS 10MM. A 7FR TERUMO SHEATH WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING BUT WHILE REMOVING THE DEVICE FROM HOOP/TRAY IT WAS NOTICED THAT THE BALLOON MATERIAL WAS WRAPPED AROUND THE DISTAL TIP OF THE SHEATH. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT AN INFLATION DEVICE WAS USED TO INFLATE THE DEVICE. THE BALLOON DETACHED/CRACKED OR FRACTURED DURING REMOVAL OF THE CATHETER FROM THE PATIENT AND THE BALLOON REMAINS IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED BUT THE REP WILL PROVIDE FURTHER DETAILS WHEN AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8370170 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.