FDA-Device2014-04-23Class I
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Hazard
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Sold states
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.
Affected count
567 units total (323 units in US)
Manufactured in
9775 Toledo Way, N/A, Irvine, CA, United States
Products
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1454-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief