Recall Z-0551-2025 ยท NVZ Pulse Generator, Permanent, Implantable
Abbott Medical
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
| Date | Nov 26, 2024 (initiated Oct 1, 2024) |
| Status | Open, Classified |
| Reason | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. |
| Root cause | Software design |
| Action | On 10/25/2024, the firm initiated notifying customers in person/verbally regarding a limited number of Merlin@home Transmitters with MerlinOnDemand Capability that are unable to upgrade to the latest version of software. This issue was caused by a power interruption during a past software updated attempt. Abbott will be retrieving and replacing the affected Transmitters. The replacement Transmitter will have the latest software update version 9.0rev1 For questions or further assistance, speak with or contact the Abbott representative that is on-site replacing the Transmitter, or contact th |
| Quantity | 130 transmitters |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.