ev3 EverCross 0 — Class II medical device recall Z-1489-2014
Terminated recall by Ev3, Inc., reported 2014-04-30, distributed in IN, NC, NY, OK, TX, WV. Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling
| Recall number | Z-1489-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ev3, Inc., Plymouth, MN, United States |
| Recall initiated | 2014-04-09 |
| Classified | 2014-04-23 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2014-10-06 |
| Distributed | IN, NC, NY, OK, TX, WV |
| Countries outside the US | AU, CN, FR, GB, IL, IT, TR |
| Reason classes | labeling |
| Lot numbers | 9852591, 9855406, AB35W06040080 |
| Model numbers | AB35W06040080, AB35W06120135, EV3 |
| Expiration dates | 2017-01-16 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1489-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.