St. Jude Medical (NYSE:STJ) shareholders filed a lawsuit this week accusing the company and its CEO of down-playing device failures that led to the recall of a set of defibrillator leads in a "scheme" to artificially inflate the company’s share price.
Recalls
Medtronic’s recalled Fidelis leads fracture after ICD swap, researchers say
Updated June 15, 2012, at 1:15 p.m. with comments from Medtronic.
A common procedure in which surgeons swap out a patient’s implantable cardioverter defibrillator may significantly increase the risk of failure for Medtronic’s (NYSE:MDT) already fracture-prone Sprint Fidelis defibrillator leads, according to a new study.
Ethicon warns on counterfeit surgical clips on the U.S. market
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery warned healthcare providers this week that it discovered counterfeit LigaClip surgical devices in distribution in the U.S.
St. Jude shares sink on single Durata lead wire defect report
St. Jude Medical (NYSE:STJ) shares closed down 6% after a single incident of wire externalization in 1 of its next-generation Durata defibrillator leads – the same issue the launched the high-profile recall of the company’s Riata leads.
MassDevice.com +3 | The top 3 med-tech stories for June 12, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Cordis issues “urgent” recall on Fire Star Rx balloon catheters
Updated June 12, 2012, at 9:30 p.m. with comments from Cordis.
Johnson & Johnson (NYSE:JNJ) subsidiary Cordis Corp. launched an urgent product recall for a single lot of its Fire Star Rx PTCA dilation catheters over concerns that the devices may not deflate properly.
J&J’s decision to pull women’s mesh is not a recall
Johnson & Johnson (NYSE:JNJ) isn’t recalling its controversial transvaginal mesh products, but is pulling them off the shelves in response to the more than 600 women who have filed lawsuits claiming personal injury as a result of having receiving the implants.
Medical device recalls for May 2012
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
MassDevice.com +3 | The top 3 med-tech stories for May 29, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Recalls: Edwards pulls Perimount heart valves over packaging concerns
Edwards Lifesciences (NYSE:EW) issued a recall of certain lots of Perimount replacement heart valves over concerns that they may have been contaminated with "extremely small" metallic particles during packaging.
Breast implants: More women affected by PIP scandal
New reports from the U.K.’s Medicines & Healthcare Products Regulatory Agency warn that even more women may have received breast implants with substandard silicone that’s prone to rupture.
The agency advised health care providers to begin assessing patients who received breast implants made by Poly Implant Prosthèse, expanding the warning which originally applied only to implants distributed after January 2001.