Merlin 2 PCS MER3400 programmer software recalled by St. Jude Medical
St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall affecting programming systems for implantable cardiac devices. No illnesses or deaths reported in the source material. Classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
St. Jude Medical, Cardiac Rhythm Management Division, is recalling Merlin 2 PCS MER3400 programmer software. This is an FDA Class II medical device recall.
The recall affects approximately 622 programmer units with software model MER3400 version 1.1.2 revision 1 or earlier (UDI/DI 05415067037121). These portable programming systems are used to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up procedures. The recalled units were distributed across the United States and internationally to numerous countries.
Patients and healthcare providers using affected programmers should contact St. Jude Medical for guidance on addressing this recall. The FDA Class II classification indicates a defect that has a reasonable probability of causing serious adverse health consequences.
The recalled product
- Product
- Merlin 2 PCS MER37000 programmer Model MER3400 software
- Affected units
- 622
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Model MER3400 v1.1.2 rev 1 or earlier.
- UDI/DI 05415067037121
Distribution
Part of a larger recall action
This product is one of 3 recalled by St. Jude Medical, Cardiac Rhythm Management Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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