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U.S. Department of Health and Human Services

Class 2 Device Recall Accent family of pacemakers

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  Class 2 Device Recall Accent family of pacemakers see related information
Date Initiated by Firm August 28, 2017
Create Date June 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-0035-2018
Recall Event ID 78093
PMA Number P880086S283 
Product Classification Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
Product 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 continuous cardiac rhythm disorders.
Code Information Serial Numbers: 2736872 2736871 2736870 2736874 2736873 2538305 2538304 2538301 2538306 2538307 2538302 2512808 2512812 2512811 2384089 2512807 2384108 2384112 2397881 2393253 2393254 2401631 2512803 2401623 2401617 2512810 2384086 2384126 2384101 2384122 2384121 2384105 2384096 2384098 2384116 2384110 2384111 2384120 2384082 2384085 2384123 2384124 2384107 2384117 2384087 2384097 2384077 2393264 2384115 2384119 2384114 2384104 2384100 2384078 2384092 2384081 2384084 2397878 2401620 2384080 2384079 2384099 2401621 2401624 2384083 2512819 2512818 2401626 2401622 2397879 2397872 2393252 2393259 2401619 2401618 2401629 2397874 2397880 2401628 2384106 2393255 2393256 2393257 2512802 2512805 2512800 2512817 2512801 2512804 2512813 2512814 2512815 2512816 2512806 2512809 2384102 2384095 2384125 2384113 2384103 2393262 
Recalling Firm/
Manufacturer
St Jude Medical Inc.
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Candace Steele Flippin
651-756-6293
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 101 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LWP and Original Applicant = St. Jude Medical, Inc.
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