Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Recall Z-0030-2018 · Posted None
Recalling FirmSt Jude Medical Inc.
Recall StatusTerminated
Product CodeDXY
Date Initiated2017-08-28
Date Terminated2020-07-08
Product Quantity529912 units
Reason for Recall
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.