FDA Urgent Voluntary Recall of Brain Catheter

On January 29th, the FDA revised Penumbra’s Urgent Voluntary Recall of the Jet 7 Catheters with Distal Tip. The FDA has received over 200 reports of adverse reactions to their Medical Device Reporting system (MDRs) including death, serious injury and malfunctions. Serious injuries have been described as vessel damage, hemorrhage, and cerebral infarction. The Penumbra system is used in stroke patients to remove blood clots, during a bench test performed by the manufacturer, the distal tip was not able to withstand the same burst pressure as the other catheters manufactured by the same company.

‘Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.’

Over twenty-thousand devices have been recalled, Health Care officials were notified on December 15th, 2020, when the voluntary recall was initiated.

URL: https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality
and
https://www.fda.gov/medical-devices/medical-device-recalls/penumbras-recall-jet-7-reperfusion-catheter-due-distal-tip-damage

The Largest Automobile Recall Ever Now Affects 34 Million Vehicles

By Sophie Williams –

Tuesday Takata decided to expand the recall of vehicles with its air bags to nearly 34 million cars and trucks, nearly double the number of vehicles previously recalled.

The company agreed to a national recall of certain types of driver and passenger side air bag inflators used in vehicles manufactured by BMW, Chrysler, Daimler AG trucks, Ford, General Motors, Honda, Mazda, Mitsubishi, Nissan, Pontiac, Saab, Subaru and Toyota. Six deaths and more than 100 injuries have been linked to the defective air bags.

If you or someone you know has been injured or killed by a Takata airbag, please contact the Nations Law Firm for a free case evaluation by one of our experienced attorneys.

For information regarding the organization of the recall: http://www.safercar.gov/rs/takata/index.html