Medical Device Safety and Recalls: 04/21/2014

Covidien, Pipeline Embolization Device and Alligator Retrieval Device  – Coating on Delivery Wire Could Delaminate and Detach – (Certain Catalog / Lot Numbers)
A recall has been issued for the Covidien, Pipeline Embolization Device and Alligator Retrieval Device (certain catalog / lot numbers). The devices have the potential for the PTFE coating to delaminate and detach from the delivery wire. PTFE particulate resulting from the delaminated coating can cause a blockage (embolism) in blood vessels in the brain with the risk of stroke and/or death. The firm received one report of an incident in which the delamination occurred, with zero injuries and zero deaths. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm394137.htm