Z-2329-2018 Class II Terminated
FDA device recall Z-2329-2018 was initiated by St Jude Medical Inc. on April 16, 2018 and is designated Class II. 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 addit… The recall status is terminated (terminated March 8, 2024). Affected quantity: 71651.
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2018
- Initiation Date
- April 16, 2018
- Termination Date
- March 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71651
Product Description
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
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.
Distribution Pattern
U.S. Nationwide distribution
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)