Recall Z-0949-2015
St Jude Medical Cardiac Rhythm Management Division · initiated December 18, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Codes / lots: Serial No. 25117181 25102957 25087732 25089415 12425463 25095596 25184682 12485839 25102906 25154103 25108918 25025302 12381443 25038455 25092708 12221170 25112136 25169594 25137228 25093615 25141686 25117458 25111604 25093649 25132546 25103939 25138550 25141540 25095698 25083041 12204274 12296007 25162338 25072003 25096827 25136903 25091678 25159164 25111804 25169442 25069921 12376794 25074237 25083876 25136384 25064617 12297599 25091439 25068034 25172146 25074154 25074190 25077852 25064811 12351513 25074801 25083477 12299937 25147716 25078787 25111411 12333835 25157659 25120763 25072304 25083123 25115365 25065318 12243413 25046069 12241670 12345709 12430239 25151639 25013443 25194240 12440854 12490301 12365721 12307572 25151201 25073392 25137086 25075167 12212657 25023097 12201701 12436413 25090438 25162500 25084216 25074239 25122865 25064060 25078847 25081883 25158300 25156425 25108020 25131891 25099682 25044455 25085127 12319299 25092986 25164788 25098858 25147437 12364659 25099680 12203035 25162977 25083707 25130451 12268716 25094478 25165470 25120979 25164423 12276169 25091327 25145089 25104189 12301806 25100142 25106010 25128023 25092563 25195551 25070168 25110871 25170212…
Reason for recall
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
FDA-determined cause: Device Design
Action taken
The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.
Details
- Recall number
- Z-0949-2015
- Initiated
- December 18, 2014
- Posted by FDA
- January 9, 2015
- Terminated
- March 30, 2016
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 257,456 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
- Recalling firm
- St Jude Medical Cardiac Rhythm Management Division, Sylmar, CA