Device evidence

device-recall:cfres:210583

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

Official recall number

Z-0552-2025

Evidence summary

Product code: NVZ
Recall status: Open, Classified
Event initiated: October 01, 2024
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0552-2025