ev3 — Class II medical device recall Z-1552-2016
Terminated recall by ev3, Inc., reported 2016-05-04, distributed in CA, GA, LA, MI, MO, MS, NH, NV…. Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over t
| Recall number | Z-1552-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ev3, Inc., Minneapolis, MN, United States |
| Recall initiated | 2016-03-29 |
| Classified | 2016-04-22 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2017-05-19 |
| Distributed | CA, GA, LA, MI, MO, MS, NH, NV, NY, OH, PA, SD, TX |
| Countries outside the US | SG |
| Reason classes | labeling |
| Model numbers | AB18W030200150 |
Product
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Reason for recall
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
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-1552-2016. 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.