Medtronic, a medical device manufacturer who has formerly warranted a dangerous device warning in the pages of this Tennessee Law Blog, has been issued a FDA Class I Recall for a series of its defective infusion pumps.
(For explanation of why defective infusion pumps are dangerous, check out Tennessee Law Blog’s defective device article on the dangerous Alaris Pump modules.)
A Class I Recall is the most severe action FDA officials take. Class I Recalls are reserved for drugs and dangerous medical devices for which there is a reasonable probability that use will cause serious injury or death.
Medtronic’s defective implantable infusion pumps have been subject to a series of sanctions. On August 3, 2007, Medtronic sent notification letters describing the problems of these defective devices manufactured before September 1999. In these Medtronic infusion pumps, a defective pump motor has been known to stall, which means the delivery of vital drugs will suddenly stop without notice. The lack of vital drugs can result in the return of a patient’s symptoms, injury to the infusion pump’s user, and, reportedly, death in cases of drug withdrawal from Intrathecal Baclofen (ITB) therapy (injections into the spine).
The models of SynchroMed EL Implantable Infusion Pump Models subject to recall are as follows:
- Infusion Pump Model 8626-10
- Infusion Pump Model 8626L-10
- Infusion Pump Model 8626-18
- Infusion Pump Model 8626L-18
- Infusion Pump Model 8627-10
- Infusion Pump Model 8627L-10
- Infusion Pump Model 8627-18
Infusion Pump Model 8627L-18
Most patients who use the infusion pump are sufferers of cancer or of severe pain.
Consumers with questions may contact Medtronic Neuromodulation Patient Services at 1-800-510-6735.
Consumers in the State of Tennessee seeking compensation for the injuries caused by Medtronic’s defective devices can call my Nashville law offices at (615) 353-0930 or use HHP’s quick dangerous and recalled medical products form.