GE Healthcare (NYSE:GE) landed Class I status for its Aestiva/5 7900 ventilator recall, a category the FDA reserves for the most serious issues "in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
Recalls
China regulators warn on Micro-Pace pacemakers | MassDevice.com On Call
MASSDEVICE ON CALL — China’s Dept. of Health warned local healthcare providers of potential sensing issues noted in dual-chamber temporary pacemakers made by Pace Medical.
The warning involves Micro-Pace Model 4580 systems, programmable, multi-mode, multi-parameter cardiac pacemakers made by San Diego-based Pace Medica. The Micro-Pace devices also have FDA approval in the U.S.
MassDevice.com +7 | The top 7 med-tech stories for the week of July 2, 2012
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’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 this weekend, make sure you’re still in the know with MassDevice +7.
FLASH: Stryker recalls pair of metal hip implants, halts global production
MassDevice.com +3 | The top 3 med-tech stories for July 3, 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.
CareFusion issues pair of recalls, increases “recall reserve” fund by $7M
CareFusion (NYSE:CFN) issued a pair of recalls involving its AirLife infant breathing circuits and certain Alaris infusion pumps, in the process adding $7 million to its "recall reserve" for the 2nd quarter.
Medical device recalls for June 2012
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
FDA chides Covidien on handling of surgical staple recall
MassDevice.com +3 | The top 3 med-tech stories for June 25, 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.
Terumo warns on rare air bubble alert system failure on heart-lung machines
Terumo Corp. (TYO:4543) warned users of its Advanced Perfusion System 1, Sarns Modular Perfusion System 8000 and Sarns Perfusion System 9000 of possible malfunctions related to the devices’ air bubble detections systems.
The company has received "multiple reports" of false alarms generated by the air bubble warning system, although it’s a "highly unlikely" malfunction.
St. Jude Medical: Failed Durata lead not related to Riata issues
St. Jude Medical (NYSE:STJ) said the Durata lead failure that slashed its share price 2 weeks ago was due to external failure, rather than the "inside-out" abrasion found with its recalled Riata leads.