Reported Apr 27, 2022 · Ongoing
Merlin 2 PCS MER3700 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Merlin 2 PCS MER3700 programmer Model MER3400 software
- Lot codes and dates
- Model MER3400 software Versionv1.X
- X UDI05415067037121
- Serial Numbers of affected Systems
401 of 401 codes
130000011300000213000003130000041300000513000006130000071300000813000009130000101300001113000014130000151300001613000017130000191300002113000023130000241300002513000026130000271300002813000029130000301300003213000033130000341300003513000036130000371300003813000039130000401300004113000042130000431300004413000045130000461300004813000049130000501300005113000052130000531300005413000057130000591300006113000062130000631300006413000065130000661300006713000068130000691300007013000071
- Amount recalled
- 401 devices with software
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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