FDA Device recall Z-1489-2014
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Cath…
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Cath… by Ev3, citing 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 deliv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1489-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-09 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ev3 |
| Distribution | IN, NC, NY, OK, TX, WV |
Product
ev3 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: AB35W06040080. Peripheral Dilatation Catheter
Reason
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.
Identifiers
| code_info | AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2014%22
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