Micro Therapeutics Inc, Dba Ev3 Neurovascular: Medical Device Recall in 2014 - (Recall #: Z-1454-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

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

Product Classification:

Class I

Date Initiated: April 1, 2014
Date Posted: April 23, 2014
Recall Number: Z-1454-2014
Event ID: 67893
Reason for Recall:

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Status: Terminated
Product Quantity: 567 units total (323 units in US)
Code Information:

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

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.

Voluntary or Mandated:

Voluntary: Firm initiated