Medical device maker St. Jude Medical (NYSE:STJ) is feeling pretty confident about public perception of its Durata defibrillator leads, which came under scrutiny amid a high-profile recall of its older Riata leads.
Recalls
Device makers object to FDA’s proposed recall guidance | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA’s recent attempt to clear up confusion about official recall requirements got some negative reactions from members of the medical device industry, among them lobbying group AdvaMed and medical device company Boston Scientific (NYSE:BSX).
Pediatric ICD study finds higher rate of failure for Sprint Fidelis leads in kids | MassDevice.com On Call
J&J’s DePuy can’t dodge $8.3M metal hip implant verdict
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics is still responsible for an $8.3 million award to a patient who claimed the companies were responsible for injuries caused by recalled hip implants.
FDA Issues Draft Guidance to Help Companies Distinguish Between a Voluntary Medical Device Recall and a Product Enhancement
Symbios recalls GoPump and GOBlock kits following patient complaints
Symbios Medical Products last week recalled all of its GoPump rapid recovery systems and GOBlock kits manufactured with flow control components assembled prior to July 2012, according to the FDA.
These products were found to potentially cause excessively high flow rates, the agency reported. Due to the rapid influx of medication, particularly in patients with low body mass or advanced age, patient toxicity and serious injury including seizure, dysrhythmia and death can result, the FDA noted.
Diabetes: Abbott’s glucose monitor software glitch gets FDA’s highest-risk recall
The FDA slapped its highest-risk label on Abbott’s (NYSE:ABT) blood glucose meter recall, deeming the software glitch potentially deadly for patients.
Abbott last month said that it had already issued a free software update to patch the problem, which may affect as many as 50,000 FreeStyle InsuLinx blood glucose meters on the market.
Hip implants: Johnson & Johnson’s DePuy will stop selling metal-on-metal implants
Johnson & Johnson (NYSE:JNJ) is pulling the plug on its troubled metal-on-metal hip implant business, effective August 31.
Maquet’s Class I ventilator battery recall affects 90k units
A Class I recall, reserved for serious patient harm, was issued over battery units produced by Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular.
Synthes warns of fragmentation risk with soft tissue retractor
Hong Kong’s Medical Device Control Office said Johnson & Johnson‘s (NYSE:JNJ) Synthes division issued a warning about the risk of injury from 1 of its soft tissue retractors.
Another recall for Johnson & Johnson Down Under
Another Johnson & Johnson (NYSE:JNJ) product is the subject of a recall, this time from the Australian Therapeutic Goods Administration