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U.S. Department of Health and Human Services

Class 2 Device Recall Merlin PCS programmer

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  Class 2 Device Recall Merlin PCS programmer see related information
Date Initiated by Firm April 16, 2018
Create Date June 29, 2018
Recall Status1 Terminated 3 on March 08, 2024
Recall Number Z-2329-2018
Recall Event ID 80212
PMA Number P910023S396 P140033S010 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code OSR
Product Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Code Information Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada) 
Recalling Firm/
Manufacturer		 St Jude Medical Inc.
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Kelly Morrison
818-493-3591
Manufacturer Reason
for Recall		 The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
FDA Determined
Cause 2		 Software design
Action On 04/16/2018, Important Medical Device Advisory notifications were mailed via overnight service to U.S. physicians and hospitals notifying customers of the availability of the programmer software update and associated ICD/CRT-D firmware update. Advisory notifications were mailed to customers outside the U.S. on different dates depending on geography and local regulatory requirements. Prophylactic replacement of affected devices is not recommended. The firm recommends firmware upgrades for all eligible patients at the next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. For devices not eligible for the cybersecurity firmware update the firm recommends a discussion of the risks of cybersecurity vulnerabilities and proven benefits of remote monitoring with patients at their next regularly scheduled visit. RF communication may be permanently disabled in devices not eligible for firmware updates during an in-clinic device interrogation with a programmer that has received the software update. Customers with questions about the firmware update can call the customer technical support hotline at 1-800-436-5056.
Quantity in Commerce 71651
Distribution U.S. Nationwide 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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