FDA Device recall Z-0965-2022
Merlin 2 PCS MER3700 programmer Model MER3400 software
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Merlin 2 PCS MER3700 programmer Model MER3400 software by St Jude Medical Cardiac Rhythm Management Division, citing due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniz….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0965-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-10 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
Product
Merlin 2 PCS MER3700 programmer Model MER3400 software
Reason
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Identifiers
| code_info | Model MER3400 software Version: v1.X.X UDI: 05415067037121 Serial Numbers of affected Systems: 13000001 13000002 130000…Model MER3400 software Version: v1.X.X UDI: 05415067037121 Serial Numbers of affected Systems: 13000001 13000002 13000003 13000004 13000005 13000006 13000007 13000008 13000009 13000010 13000011 13000014 13000015 13000016 13000017 13000019 13000021 13000023 13000024 13000025 13000026 13000027 13000028 13000029 13000030 13000032 13000033 13000034 13000035 13000036 13000037 13000038 13000039 13000040 13000041 13000042 13000043 13000044 13000045 13000046 13000048 13000049 13000050 13000051 13000052 13000053 13000054 13000057 13000059 13000061 13000062 13000063 13000064 13000065 13000066 13000067 13000068 13000069 13000070 13000071 13000073 13000075 13000076 13000077 13000079 13000081 13000082 13000083 13000084 13000085 13000086 13000087 13000088 13000090 13000091 13000092 13000093 13000094 13000095 13000096 13000099 13000100 13000101 13000102 13000103 13000104 13000105 13000106 13000107 13000108 13000109 13000110 13000111 13000112 13000113 13000114 13000115 13000116 13000118 13000119 13000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0965-2022%22
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