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

Pradaxa Surpasses All Other Drugs in Adverse Event Reports Made Last Year

Posted by Amber Stanford

June 12, 2012 – More reports were made against the controversial new blood-thinner, Pradaxa, than any other drug on the market last year. And according to the Institute for Safe Medicine Practices’ (ISMP), Pradaxa also topped the list for reports of deaths, hemorrhage, acute renal failure, and stroke. Pradaxa was released as an alternative to the more common Warfarin/Coumadin. However, unlike Warfarin, Pradaxa does not currently have an antidote in the event of excessive bleeding. The FDA launched a review of Pradaxa last December based on bleeding-related side effects, while regulators in Europe and Japan have encouraged stronger warnings. The European Medicines Agency (EMA) has more recently asked for more information regarding specific uses of Pradaxa and how to manage patients using the drug.

Find more information here…