|
On January 16, 2008 the Medtronic Corporation began recalling models of its Neuromodulation Implantable Infusion Pumps. On March 21, 2008 the U.S. Food and Drug Administration (FDA) began this Class 1 recall. A Class 1 recall involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.
The Following Medtronic Neuromodulation Pumps were recalled:
- SynchroMed EL (models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, and 8627L-18),
- SynchroMed II (models 8637-20 and 8637-40), and
- IsoMed (models 8472-20, 8472-35, and 8472-60).
On January 16, 2008, Medtronic sent a letter to doctors who implanted these devices and/or provided care to patients with this implantable device. The letter described the risks and recommendations.
The pumps are used for treatment of patients by administering a specific drug to a specific site in the body to treat pain. The pump is implanted in the patient, either with or without a side catheter access port. The company received reports of an inflammatory mass formation at or near the distal tip of the catheters which inhibits the drug reaching the body or resulting in other neurological impairments.
Please visit the FDA's website if you have any questions regarding the recall.
Free Legal Consultation
If you or a loved one has an implanted Medtronic Neuromodulation Pump, you may have valuable legal rights. To protect these rights, contact Keel O'Malley Tunstall, L.L.P.today by completing the submission form on the left side of this page or by calling 1-888-KEEL-LAW (1-888-533-5529).
Remember, because of statute of limitations, you have a limited time to seek compensation. Contact Keel O'Malley Tunstall, L.L.P.so that we may assist you in protecting your legal rights.
The devices are being recalled because of the potential for failure of the device which may result in serious neurological symptoms..
We would be happy to discuss your legal rights with
you on the phone, meet with you in our office or
have one of our staff meet with you at home. There
is NO CHARGE for the initial consultation. If you
cannot come to us, we will GO TO YOU. The members of
our firm look forward to helping you with your products liability claim, call Keel O'Malley Tunstall, L.L.P. Tunstall L.L.P. at
(252) 823-2266 or toll free at 888 - KEEL - LAW, or submit an online
questionnaire.
<< Back to
Practice Areas
Email this Page
|
