Parker Waichman LLP

Crossover Sheath Introducer Recalls

  Crossover Sheath Introducer Are Being Recall. Cordis Corporation is recalling all lots of the Crossover Sheath Introducer due to complaints about stretching or fracture of the sheath during use. To date, Cordis has received six complaints about the Crossover Sheath Introducer.  No permanent patient injuries have been reported. In two instances, successful surgical intervention was […]

Crossover Sheath Introducer

 

Crossover Sheath Introducer Are Being Recall. Cordis Corporation is recalling all lots of the Crossover Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

To date, Cordis has received six complaints about the Crossover Sheath Introducer.  No permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath.

According to a Cordis press release, the Crossover Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis.  It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.

separated segments of the device can embolize downstream

In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity.  Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation.

The physician may be required to perform unplanned open surgery to remove the retained segments or control bleeding.  If a procedure has been completed successfully using the product, there is no concern.

The recall encompasses products distributed from August 14, 2009 to September 23, 2009 and includes the following lot ranges and catalog numbers:

  •     Lot range: U0000025 through U0000059
  •     Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S

Cordis has notified all customers by FedEx about the recall and is arranging for the return of all products.  Customers with questions may contact Cordis at 1-800-327-7714, 24 hours a day, seven days a week.

Cordis has apprised the U.S. Food and Drug Administration (FDA) of this action.

Need Legal Help Regarding Crossover Sheath Introducer?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

[sc name=”post-footers”]

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I was very happy with Parker Waichman services. The staff stayed in constant communication with me. Thank you.
Richard Wall
6 months ago
5 Star Reviews 150
I am a 911 first responder.iwas at the end of my rope feeling hopeless ! After speaking with Parker and waickman.i had a paralegal Ashley Lopilato Hanging my case .she was there for me every step of the way .from start To finish.even during my battle with cancer and 3 surgeries.for legal and moral support In my opinion she will make an excellent litagaor one day and be an asset to any firm . We met the other day after countless phone calls .and needless to say she immediately Made me feel like I was in good Hands ! BRAVO Ashley And a special thanks to Gina viti .thank you ladies for always giving me hope And my future to look forward for thanks to you . With my warmest regards Joe ader
joseph ader
3 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value They helped me throughout the whole process and they worked hard for me and got a generous settlement and have additional health coverage. They communicated with me and always replied to emails, texts and calls promptly. I highly recommend them!
Giovanna Losardo
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038