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Chrissie Cole

FDA – Respironics V60 Ventilators Recalled

A manufacturing issue has prompted the recall of certain Respironics V60 ventilators. The recall was initiated on July 31, 2012 after two reports of blower motor failures were received.

The…

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Consumer Reports: Most medical implants have never been tested for safety

An investigation of medical devices on the market in the United States shows that most have little, if any testing to prove their safety and effectiveness, according to Consumer Reports, an…

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79,000 Americans have Riata defibrillator leads linked to malfunction, short-circuiting deaths

A new study has found that deaths associated with Riata and Riata ST Silicone Endocardial Leads is due to short-circuiting between high voltage components caused by insulation defects, not due to…

Chrissie Cole

Medtronic Reaches Settlement With DOJ Over Kickbacks

A settlement has been reached between the U.S. Department of Justice (DOJ) and Medtronic which involved claims that the company falsely encouraged the implantation of their devices.

The $23.5…

Chrissie Cole

Heart Catheters Recalled By Boston Scientific

Boston Scientific Corp is recalling its iCross coronary imaging catheters due to reports that the catheter tip detaches during procedures.

The recall involves more than 29,000 iCross…

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J&J Recalling 384,000 Insulin Pump Cartridges that Could Fail to Deliver Correct Dosages

March 8, 2011
Leaking Insulin Pump Cartridges are under recall because the leak may interfere with its performance and create potentially life-threatening conditions.
Two reports of leaking…

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FDA Orders Studies of TMJ Jaw Implants after Reports of Pain and Need for Removal

February 7, 2011
The U.S. Food and Drug Administration (FDA), who approves and oversees the use of medical devices, has ordered three manufacturers of temporomandibular joint (TMJ) implants to…

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FDA Says Breast Implants Linked to Rare Cancer

January 26, 2011
The U.S. Food and Drug Administration (FDA) announced today that women with saline and silicone breast implants might have a “very small but significant” risk of…

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Nearly 1 in 4 Implanted Defibrillators are Unnecessary and Risky

January 5, 2011
A new study released today says 22.5% of implantable cardioverter-defibrillators (ICDs) are surgically implanted in patients who do not meet medical guidelines for these…

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Millions of Diabetes Glucose Test Strips Recalled

December 26, 2010
Abbott Diabetes Care, a division of Abbott Laboratories, is voluntarily recalling 359 million test strips used by diabetics to monitor blood glucose levels.
According to the U.S…