Marathon Flow Directed Micro Catheter — Class I medical device recall Z-0309-2017
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-0309-2017 |
|---|---|
| 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 | 66,429 units |
| Reason classes | device malfunction |
| Lot numbers | 9950007, 9950392, 9950731, 9950754, 9951451, 9951453, 9952144, 9952403, A076257, A086973, A335134, A335148, A335154, A335161, A335378, A335379, A335404, A335541, A335542, A336029, A336031, A336033, A336036, A336354, A336688, A336706, A337379, A338056, A338065, A338068 |
| Model numbers | 105-5055V02, 105-5055V05, 105-5065V02, 105-5065V05, 105-5066V02, 105-5066V05 |
Product
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
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-0309-2017. 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.