Recall Z-0035-2018 · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)

St Jude Medical Inc.

PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and

Date	Aug 28, 2017
Status	Terminated
Reason	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Root cause	Unknown/Undetermined by firm
Action	Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.
Quantity	101 units
Distribution	Worldwide Distribution
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.