Posts Tagged 'Medtronic'

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 aware of ...

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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 Shiley tracheostomy ...

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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 Corrupt Organizations ...

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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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Legal inquiries ongoing into Medtronic Infuse bone implant

Despite Minnesota-based Medtronic’s announcement that the federal government has closed its investigation into the marketing of a bone growth agent called Infuse, the company’s legal troubles are not over.

According to an article in the Pioneer Press, a number of other legal inquiries are ongoing into claims that the company promoted Infuse for off-label uses, despite reports that such uses were causing serious and permanent injuries to patients.

They include a subpoena the California Attorney General’s office issued in 2011, and several ...

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