US/Silver Spring: Thoratec Corp. issues an Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller due to injury and death hazards. FDA: http://ht.ly/Sm5gd
Direct link: http://www.fda.gov/Safety/Recalls/ucm462627.htm
Additional information:
This Urgent Medical Device Correction Letter concerns certain HeartMate II LVAS units reminding clinicians to monitor the expiration date of patient backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use.
Filed under: Death hazard, Electronics, Medical / Veterinary, US FDA | Tagged: FDA, HeartMate II LVAS, Recalls Direct RIN: 5850-2015, Thoratec Corp., Urgent Medical Device Correction Letter, US Food and Drug Administration | Leave a comment »