The Food and Drug Administration has announced a recall order issued by Medline Industries for its ACME Monaco Guidewire. According to an FDA warning, Medline issued the recall notice because of concerns that metallic coating on the products could flake off of the wire, leading to serious and potentially fatal health consequences to surgical patients.
The recalled ACME Monaco Guidewires were used to guide surgical catheters through blood vessels during a medical procedure. The guidewires were distributed as part of several surgical convenience kits that were assembled and sold by Medline Industries.
In warning about the Medline guidewire recall, the FDA classified the recall notice as a Class 1 recall. According to the FDA, Class 1 recall notices “are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recalled Medline guidewires were sold under the product name ACME Monaco Guidewire .035×150 3 MMJ TCFC item number 88241. The guidewires were distributed by Medline between March 2013 and August 2013 under the lot numbers 054372-1-1A, 054372-1-1B, and 054372-1-2A.
According to the recall notice issued by Medline:
Customers should examine their inventory, affix a provided sticker on the affected kits warning users that the Acme Monaco Guidewire .035X150 3MMJ TCFC item number 88241 has been recalled and should not be used. 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.
The decision by Medline to recall the ACME Monaco Guidewires resembles a similar recall that was issued in November 2013. That month, Medtronic recalled cardiac device guidewires marketed under the names Cougar, Zinger, Thunder, ProVia, and Attain due to the risk that the surface coating on the products could detach, leading to serious complications.
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Products such as the ACME Monaco Guidewire were made with the purpose of improving the health and quality of life for patients. But despite the efforts of the FDA and other health regulators to protect the public from injuries caused by defective medical products, thousands of patients are hurt each year because of complications from improperly manufactured drugs or devices.
At Heygood, Orr & Pearson, we believe that when companies who manufacture medical devices fail to properly ensure that their products meet minimum health and safety standards, they should be held accountable for the injuries and illnesses caused by their products. We believe that all patients deserve access to qualified legal counsel to represent their interests and ensure that their rights our protected.
Our law firm has has resolved hundreds of claims involving defective medical products, dangerous drugs, and wrongful actions on the part of doctors and hospitals. In total, the lawyers with Heygood, Orr & Pearson have secured verdicts and settlements for our clients totaling more than $200 million.
If you or a loved one has been hurt by a defective medical device or other products, you may qualify to file a lawsuit and receive compensation for your injuries. To receive a free legal consultation about your case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form located on this website.