Recall Z-0551-2025— Abbott Medical
Class III · Ongoing
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 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.. 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
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.