News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation. Lawyers for consumers and injured people.(No advice on this blog, though) mark(at)markzamora.com
Monday, February 04, 2008
Medtronic SynchroMed EL Implantable Infusion Pump
Today's news brings news of another recall:
The FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18.
The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.
Go here for more.