Covid 19 Update: In these difficult times, we wish everyone the best of health and safety. We further thank all of the essential employees still working hard to protect our communities. Our office is currently fully functional and we are available should you need via telephone, e-mail or video conference.

Nationwide Recall of Cook Medical Zilver® PTX® Drug Eluting Peripheral Stent: Risk of Death

April 30th, 2013 Uncategorized
Fellows Hymowitz Personal Injury Law Zilver Recall Attorneys

Cook Medical has initiated a nationwide recall of its Zilver PTX Drug Eluting Peripheral Stent after receiving several complaints about delivery system tip separation issues. Two adverse complications, including one death, occurred in cases where a tip separation was reported.

The recall includes all sizes, diameters and lot numbers of the defective product. These devices were distributed to medical institutions and distributors across the United states between December 13th 2012 and April 16th 2013. The recall is specific to the delivery system, not the stent itself, according to Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Interventional clinical division. If you are unsure if you are using this particular device, contact your doctor immediately.

Cook Medical has already received 13 complaints that the delivery system becoming separated at the tip of the inner catheter while in use. Cook’s investigation identified an internal component of the delivery system used to implant the stent that did not consistently meet  design criteria specifics.

Potential adverse reactions/injuries include: surgery to remove the catheter tip; vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, severe pain, infection, possible cardiac arrest and even death. People who have the device should stop using it at once. Cook medical is issuing full refunds for the defective product.

Patients with Zilver PTX stents implanted in whom the delivery system was removed safely and intact are at no risk and are not affected by this recall. Bare metal versions of Cook Medical’s Zilver Flex stent use a different delivery system that is not included in this recall.

Adverse events can be reported to Cook Medical or to the FDA via MedWatch at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

The attorneys at Fellows Hymowitz P.C. have a record of success in handling a wide range of cases including injuries caused by medical malpractice. We bring the same individual commitment and dedication to each case, big or small. If you have been injured or sustained loss in any type of accident as a result of someone else’s fault call us for a free confidential consultation at 845-639-9300.

Fellows Hymowitz, PC, The Right Lawyers Make a Real Difference

Steve Hymowitz an extraordinary attorney!!!!
He was the 5 th attorney that I had called after I was In a bad car accident that I sustained lifetime injuries from. All the other attorneys said “no, sorry I can’t help you since you had a fender bender years ago with some minor injuries when someone hit you at a red light.
I was flabbergasted because the injuries I had prior, were so minimal . The debilitating and multiple issues I had in this accident, I knew would be lifetime struggle but Nobody would listen to me.
So calling Mr Hymowitz’s office, I was told it would be very tough and he would do extensive research regarding all aspects of this case and fight every detail on my behalf …and he did!!!!! His Practice being in New York and New Jersey was a plus for my case.

Lynn, his right hand paralegal, ( who guided me every step of the way) told me through this whole process you watch, “he’s amazing, he is an extraordinary attorney and you’ll be amazed at what he could do ….. she was right!!!!
Lynn made this process so much easier with her continued communication to me, her empathy and her tolerance!
I have been in the medical and business field for years prior to the accident. I feel that I was very lucky and blessed to have this very professional, respectful, and very educated Gentleman as my warrior who truly fought so hard for me!!! I loved that he always kept me in the loop with great communication!
I found him to be a very caring human being!

My settlement was more than I could’ve imagined!!
And that’s because he proved the truth of my injuries!

I am forever grateful for Steve Hymowitz!

- Christine Spicochi