Reported Apr 30, 2014 · Terminated
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW…
Ev3, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ev3, Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890
Is this the product you have?
- ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm
- REFAB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm
- REFAB35W06040080. Peripheral Dilatation Catheter
- Lot codes and dates
- AB35W06120135 Lot9855406
- Use by2017-01-16
- AB35W06040080 Lot9852591
- Use by2017-01-16
- Amount recalled
- 39 units (31 OUS, 8 US)
Where it was sold
Why it was recalled
Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ev3, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.