FDA Device recall Z-2405-2026
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software by Abbott Medical, citing software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2405-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Reason
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Identifiers
| code_info | Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-04-23 · Abbott Medical - The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates u…
FDA Device · Class II · 2025-01-01 · Abbott Medical - Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitte…
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.