FDA Device recall Z-1453-2014
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery
- FDA Device
- Class I
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class I recall of Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery by Micro Therapeutics, citing potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1453-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-01 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Micro Therapeutics |
| Distribution | US |
Product
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Reason
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Identifiers
| code_info | PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856…PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1453-2014%22
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