Recall Z-0949-2015 ยท NVZ Pulse Generator, Permanent, Implantable
St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
| Date | Jan 9, 2015 (initiated Dec 18, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 D |
| Quantity | 257,456 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.