Legal Updates
Medtronic Heparin-Coated Devices Recalled
Thursday, May 08, 2008
Medtronic Inc. announced on May 7, 2008 a recall of some devices used in heart bypass surgery because their coating includes small amounts of contaminated Heparin, a blood thinner that in larger doses has been linked to 81 deaths. Most of the Heparin recently recalled by other manufacturers was administered…
FDA Approves Email Notification For Recalls
Monday, April 07, 2008
The FDA recently agreed on the use of e-mail to notify physicians of dangerous drug and medical device recalls. To date, safety alerts were issued to the media instantly, but they were sent to doctors in the mail. "A lot of times I hear about products being withdrawn from my…
FDA Seeks Additional Info on Stents
Wednesday, March 26, 2008
On March 26, 2008, the FDA announced new guidelines for the testing of drug-coated stents, more than two years after safety concerns curtailed use of the devices. The planned guidelines posted to FDA's Web site suggest device makers conduct large, analytic studies of their stents both before and after they…
Medtronic Recalls Intrathecal Infusion Pumps
Tuesday, March 25, 2008
On March 21, 2008, the FDA issued a class 1 recall for Medtronic Neuromodulation's implantable infusion pumps. Affected devices include 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). The action was based on…
SynchroMed E1 Pumps Cause Another Medtronic Recall
Monday, February 04, 2008
The FDA recalled SynchroMed El pumps, a heart product from Medtronic, on February 4, 2008 after reviewing reports that the pumps motors failed. The recalled SynchroMed El pumps were manufactured in Fridley, Minnesota and Puerto Rico. To date, no fatalities or serious injuries related to the products have been…
Man seeks psychiatrist after Medtronic recall
Thursday, January 24, 2008
A Texas resident is claiming the unexpected shocks he received from a cardiac defibrillator constitute civil battery and caused him such severe anxiety that he is suffering from post traumatic stress and now requires psychiatric care. Donald Larry Jackson filed a product liability suit against Medtronic on Jan. 18 in…
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