X-Celerator Hydrophilic Exchange Guidewire Catalog No — Class I medical device recall Z-0310-2017
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2016-11-16, distributed nationwide. Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in
| Recall number | Z-0310-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA, United States |
| Recall initiated | 2016-10-05 |
| Classified | 2016-11-09 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IR, IT, JP, KR, LT, LV, MX, MY, NI, NL, NP, PA, PE, PH, PK, PL, PT, PY, SA, SE, SG, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 10,516 units |
| Reason classes | device malfunction |
| Model numbers | 103-0601-300, 103-0601-300V01, 103-0601-300V02, 103-0601-300V03, 103-0601-300V06, 103-0601-300V10, 103-0601-300V11, 103-0601-350, 103-0601-350V01, 103-0601-350V06, 103-0601-350V10, 103-0602-300, 103-0602-300V01, 103-0602-300V02, 103-0602-300V06, 103-0602-300V09, 103-0602-300V10, 103-0602-350, 103-0602-350V01, 103-0602-350V02, 103-0602-350V06, 103-0602-350V09, 103-0602-350V10 |
Product
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
Reason for recall
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
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-0310-2017. 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.