Medtronic Recalls 60,000 Paradigm Quick-Set Infusion Sets
July 14, 2009
Medtronic has issued a recall of specific lots of infusion sets that are for use with MiniMed Paradigm insulin pumps. These infusion sets may not work properly, resulting in a delivery of too little or too much insulin, which could result in injury or death.
Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets In The United States
July 1, 2009
UPDATED URL > Click Here for information on the Medtronic Paradigm Quick Set Infusion Set Recall
FDA Classifies Medtronic Voluntary February Recall for BioGlide Ventricular Snap Shunt Catheters (Models 27782, 27708 and 27802) as Class I
March 31, 2009
CONTACT: JEFF WARREN INVESTOR RELATIONS 763-505-2696
CHUCK GROTHAUS PUBLIC RELATIONS 763-505-2614
Urgent Medtronic Neuromodulation INDURA IP Product Recall
October 2, 2008
FDA has issued a Class I Recall on Medtronic Neuromodulation INDURA IP intrathecal catheters, sutureless pump connector revision kits and intrathecal catheter pump segment revision kits.
There are potential misconnections of the Medtronic sutureless connector (”SC”) catheters from the catheter port on the medtronic pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector.
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products
May 15, 2008
CONTACT: DANIEL BEACH PUBLIC RELATIONS 763-505-2603
Medical Device Litigation 101
February 25, 2008
Medical Device Litigation History and Primer
1976 through Reigel v. Medtronic
Guest post provided by Denver personal injury attorney Beth Klein
Background of the Act
The Food & Drug Administration (”FDA”) governs medical devices for use and sale in the United States. The FDA was given power over medical devices in the 1976 Medical Device Amendments to the Food, Drug, & Cosmetic Act, 21 U.S.C. section 360c et seq. (AMDA@). The purpose of the MDA was to provide reasonable assurance of safety and effectiveness for all medical devices.
Supreme Court Grants Immunity to Medical Device Manufacturers
February 21, 2008
(Editorial Content)
The Supreme Court finally gave medical device makers their one true wish – Immunity from Lawsuits. Companies that produce medical devices like breast implants and implantable defibrillators now have federal protection against lawsuits arising from deaths or injuries associated with their products as long as the product has been approved for use by the FDA.
Medtronic SynchroMed EL Implantable Infusion Pumps Recalled
February 4, 2008
In a Class 1 Recall yesterday, the U.S. Food and Drug Administration has recalled all SynchroMed El pumps with motors manufactured after September 1999.
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