Recall Z-0552-2025
Abbott Medical · initiated October 1, 2024
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
Codes / lots: Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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 the Public Contact at 408-845-3427
Details
- Recall number
- Z-0552-2025
- Initiated
- October 1, 2024
- Posted by FDA
- November 26, 2024
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- Pending
- 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, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of…
- Recalling firm
- Abbott Medical, Sylmar, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0551-2025 Class III | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to…Due to heart transmitter not being able to upgrade to the current software version in the field after… | 10/01/2024Open, Classified |