February 25, 2014 — Medline Industries and the U.S. Food and Drug Administration (FDA) have announced a Class 1 recall because the surface coating can flake off the wire inside a patient’s body, with potentially life-threatening consequences.
Medline sent customers a Recall Notification on August 14, 2013 with information about the problem. The defective products were sold from March – August 2013. They are used in various surgical convenience kits, and they are intended to fit inside a percutaneous catheter for the purpose of directing a catheter through a blood vessel.
“The affected guidewires should be removed from the kit and returned to Medline. The rest of the kit may be used and the affected guidewire may be replaced with a sterile product from supply. If additional stickers are needed, please call 1-866-359-1704.”
- ACME Monaco Guidewire .035×150 3MMJ TCFC item 88241
Product codes and lot numbers:
Medtronic Guidewire Recall
In November 2013, Medtronic Inc. issued a Class 1 recall for cardiac device guidewires with a similar defect — the surface coating could delaminate and detach, which could potentially cause severe injury or even death.
Medtronic guidewires in the following product lines were recalled:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guidewire
Do I have a Defective Guidewire Lawsuit?
The Schmidt Firm, PLLC is currently accepting defective guidewire induced injury cases in all 50 states. If you or somebody you know has been injured by the Monaco ACME Guidewire, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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