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U.S. Department of Health and Human Services

Class 2 Device Recall MerlinHome

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  Class 2 Device Recall MerlinHome see related information
Date Initiated by Firm August 28, 2017
Create Date June 12, 2018
Recall Status1 Terminated 3 on July 08, 2020
Recall Number Z-0033-2018
Recall Event ID 78093
PMA Number P910023S386 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code OSR
Product Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W.
The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.
Code Information Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334
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 495,011 units (391,093 in US)
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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