Pipeline Embolization Device — Class I medical device recall Z-1453-2014
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2014-04-23, distributed nationwide. Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
| Recall number | Z-1453-2014 |
|---|---|
| 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 | 2014-04-01 |
| Classified | 2014-04-16 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2014-10-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CO, DE, DK, ES, FR, GB, HU, IT, MX, NL, NO, PL, PT, RU, SI, SK, TR |
| Reason classes | device malfunction |
| Lot numbers | 9855265, 9855921, 9855933, 9856429, 9856431, 9858010, 9859214, 9860762, 9864827, 9868888, 9869991, 9873854, 9874111, 9875267, 9879180, 9879718, 9879736, FA7150035, FA7730010, FA7732514, FA7735014, FA7735016, FA7737514, FA7737516, FA7740016, FA7742512, FA7742518, FA7745014, FA7745016, FA7747514 |
Product
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Reason for recall
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
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-1453-2014. 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.