Micro Therapeutics Inc, Dba Ev3 Neurovascular: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Agency Publication Date: April 16, 2014

Affected Products

Product: Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

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

Lot Numbers:

FA7735014

Product: Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

ARD Model/ Lot FA8881040 / 9769118 FA8881030 / 9816048 FA8881040 / 9754682 FA8881050 / 9772283 FA8881040 / 9752800 FA8881030 / 9751662 FA8881030 / 9773525 FA8881020 / 9832735 FA8881040 / 9757667 FA8881020 / 9774620 FA8881030 / 9834039 FA8881040 / 9758530 FA8881020 / 9774620 FA8881030 / 9834039 FA8881030 / 9758532 FA8881030 / 9783730 FA8881020 / 9836553 FA8881050 / 9760946 FA8881040 / 9786013 FA8881030 / 9834039 FA8881030 / 9761690 FA8881040 / 9787928 FA8881050 / 9848544 FA8881020 / 9761692 FA8881030 / 9791385 FA8881030 / 9848543 FA8881030 / 9758532 FA8881040 / 9793305 FA8881030 / 9853152 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9854769 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9858153 FA8881040 / 9764212 FA8881050 / 9801041 FA8881030 / 9865759 FA8881030 / 9766949 FA8881020 / 9811215 FA8881050 / 9868025 FA8881030 / 9769117 FA8881030 / 9813908

Lot Numbers:

FA8881040

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67893

Status: Resolved

Manufacturer: Micro Therapeutics Inc, Dba Ev3 Neurovascular

Manufactured In: United States

Units Affected: 2 products (32 units total (23 units in US); 567 units total (323 units in US))

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

Lot Numbers:

FA7735014

Product: Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

Lot Numbers:

FA8881040