FDASeptember 29, 2016device
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
What to do
FDA enforcement status: Terminated
Brands named
sentreheart
Recall history
No related federal recalls on record for this brand yet.
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