Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

Recalled April 23, 2014 · FDA recall Z-1454-2014 · Micro Therapeutics Inc,

Hazard

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

Units

567 units total (323 units in US)

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →