martes, 12 de mayo de 2020

Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use

https://www.fda.gov/medical-devices/medical-device-recalls/applied-medical-recalls-python-embolectomy-bard-embolectomy-and-otw-latis-cleaning-catheters-due?utm_campaign=2020-05-12%20Applied%20Medical%20Recalls%20Cleaning%20Catheters&utm_medium=email&utm_source=Eloqua

Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use

Applied Medical is recalling their Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters because there is a risk of the catheter tip detaching during use. If the tip detaches, pieces of the catheter could break off into the patient’s body.

If this occurs, there is also the potential for serious health consequences including additional surgical procedures to remove the tip, damage to the blood vessel, or death.

There have been 46 complaints regarding this device issue since 2015. The FDA has received three medical device reports (MDRs) and no reports of death or injury.  

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