Covidien (NYSE:COV) announced a new recall, its 2nd in as many months, after receiving reports of serious burn injuries associated with certain grounding pads contained in ablation device kits.
Recalls
St. Jude Medical slides on FDA order
St. Jude Medical‘s (NYSE:STJ) shares dropped more than 4% yesterday after the FDA ordered the medical device company to run a 3-year surveillance program of its recalled Riata defibrillator leads, plus 3 other leads that are still on the market.
FDA orders St. Jude to conduct 3-year review on Riata, Durata and other leads
The FDA ordered St. Jude Medical (NYSE:STJ) to launch a 3-year postmarket review on its recalled Riata and Riata ST defibrillator leads as well as for its QuickFlex LV CRT, QuickSite LV CRT, Riata ST Optim and Durata leads.
Recall: Covidien pulls breathing tubes over leak concerns
Covidien (NYSE:COV) recalled certain lots of its cuffed Shiley tracheostomy tubes after receiving reports that the devices malfunctioned during patient ventilation.
The recall received Class I status from the FDA, designating a device issue "in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
High-voltage Riata ST defibrillator lead failure and its implications for Durata
It came from a case report published online before print in PACE from Dr. John Marenco of Tufts University in Springfield, Massachusetts:
Recall: Ethicon Endo-Surgery pulls surgical staplers over performance issues
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery pulled more than 500 lots of its Proximate surgical staplers over performance issues that may cause the devices to misfire.
Medical device recalls for June 2012
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
CareFusion 303; Inc. Jul-26-2012 Alaris PC unit – Alaris PC unit model 8015Product Usage: The device is labeled for prescription use only. The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.
MassDevice.com +3 | The top 3 med-tech stories for July 31, 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.
St. Jude Medical recalls Eon, Eon Mini pain management implants on battery, charging issues
St. Jude Medical (NYSE:STJ) advised doctors and patients last week that it’s recalling some of its Eon and Eon Mini pain management implants after hundreds of the neurostimulation devices had to be taken out when their batteries failed too soon or because they overheated while recharging.
Philips warns of accelerated wear on emergency defibrillators
Health products company Philips Healthcare warned Hong Kong regulators on potential problems in its HeartStart MRx heart monitors and defibrillators, which may not hold up in a "transport environment" such as emergency medical services.
The devices may exhibit "accelerated wear" in high-stress use environments, which may cause breakdowns at the therapy connection port.
That could eventually prevent the device from sensing when its therapy paddles are connected, preventing the system from providing therapy.
FDA OKs edible sensor “pill” under new device category | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA handed Proteus Digital Health clearance for its novel ingestible sensor, passing the product through a new medical device category.
The sensor is swallowed in a pill and powered through contact with stomach fluids. The device communicates wirelessly with a patch on the skin, which collects metrics such as heart rate, body position and activity.