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Medtronic and Vitatron pacemakers are interrogated and programmed by Medtronic Carelink Model 2090 Programmer for Medtronic and Vitatron Devices; they use separate interfaces. [75] In 2007, Medtronic recalled its Sprint Fidelis product, the flexible wires, or leads, which connect a defibrillator to the interior of the heart.
The cause of the recall was a "J lead" electrode, utilizing a rigid stylet within the helix of the electrode lead, inherited by the company in acquisition of pacemaker lead manufacturer Cordis Corporation of Miami. The inherent dangers arising from incorporation of a rigid stylet had been demonstrated by Telectronics, Sydney, in 1967.
On September 22, Guidant issued safety advisories and recalls for 170,000 of their pacemakers, 56% of their total pacemakers. On October 18, Johnson & Johnson gave an announcement that they were exploring alternatives to the acquisition, followed by a November 2 warning that they might pull out of the deal due to the regulatory issues and legal ...
Medtronic Plc (NYSE:MDT) has initiated a recall for some versions of its StealthStation S8 application. The FDA deemed software recall as Class I, the most serious kind. The medical device giant ...
The U.S. Food and Drug Administration has issued a Class I recall, the agency's most serious, for a Medtronic device used to temporarily drain spinal fluid from patients after surgery for a ...
Medtronic Inc (NYSE: MDT) is recalling HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use.
Medtronic Plc (NYSE: MDT) received a warning letter from the FDA highlighting certain concerns related to medical device quality requirements at the Company's diabetes business headquarters. The ...
These factors can contribute to an increased rate of complications which can lead to pacemaker failure. [ 2 ] Approximately 2.25 million pacemakers were implanted in the United States between 1990 and 2002, and of those pacemakers, about 8,834 were removed from patients because of device malfunction most commonly connected to generator ...