Alligator Retrieval Device The device is intended for use in the… — Class I medical device recall Z-0308-2017
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-0308-2017 |
|---|---|
| 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 | 3,337 units |
| Reason classes | device malfunction |
| Lot numbers | 9973587, A003969, A003985, A004024, A004819, A004964, A004983, A005025, A005630, A005730, A006093, A006966, A007043, A008142, A008144, A011434 |
| Model numbers | FA-88810-20V04, FA-88810-20V06, FA-88810-30V04, FA-88810-30V06, FA-88810-40V04, FA-88810-40V06, FA-88810-50V04, FA-88810-50V06 |
Product
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
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-0308-2017. 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.