Posts Tagged 'Medtronic'

Medtronic Heart Catheter Recalled After Injuries, Deaths

recall issued for Medtronic heart cathetersA recall has been issued for the Medtronic Rashkind balloon septostomy catheter. 142 of the devices are covered under the federal recall action and were distributed throughout the United States between May 2018 and August 2020.

According to the FDA, the recall was issued because “quality issues…may lead to the device breaking, separating or failing during use.” The agency goes on to say that “if this occurs, use ...

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Medtronic Stapler Litigation Shows Ties to Secret FDA Database

Medtronic stapler lawsuits show ties to secret fda loophole databaseWhen news broke of an internal FDA database of medical device injuries so secret that few within the agency even knew of its existence, the discovery obviously led to the raising of a multitude of questions. Why was an agency tasked with keeping American families safe allowing the companies it was supposed to be regulating to hide reports of injuries caused by their devices? Why was ...

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Medtronic Heart Pump Recalled Over Potentially Fatal Flaw

medtronic heartware hvad system under recallLast year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.

Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic was ...

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Medtronic Issues Worldwide Recall of Covidien Shiley Tracheostomy Tubes

recall issued for tracheostomy tubesIreland-based medical device company Medtronic has issued a worldwide recall of certain lots of its Covidien Shiley neonatal and pediatric tracheostomy tubes. According to the U.S. Food and Drug Administration (FDA), Medtronic announced on May 8 that it had begun “notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012.”

The ...

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Humana Sues Medtronic for Paying Doctors to Promote Infuse for Improper Use

Humana sues accusing Medtronic of improper marketing of Infuse bone graft drugHealth Insurer Humana Inc. is suing Medtronic Inc. alleging the device manufacturer paid $210 million to market its Infuse bone-graft drug to doctors for improper use. Humana claims the doctors then pushed the use of Infuse for use in certain neck and spine surgeries, which is not approved by the FDA. The health insurer is suing under the federal Racketeer Influenced and ...

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Report: Bone growth device a ‘cautionary tale’

A joint report by MedPage Today and the Milwaukee Journal Sentinel takes a look at a bone growth agent called Infuse, made by Medtronic, which has caused a number of health problems in patients who received it.

According to the report: “The story of how the product … went from revolutionary advance to public health alert is a cautionary tale that is equal parts the art of medicine and the art of the deal.”

The report describes the Infuse product as ...

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