Recall Z-0552-2025— Abbott Medical

Class III FDA medical device recall by Abbott Medical, initiated 2024-10-01. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..

Recalling firm

Abbott Medical

Classification

Class III

Status

Ongoing

Initiated

2024-10-01

Firm location

Sylmar, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.