Merlin 2 PCS programming software for implantable devices recalled
St. Jude Medical recalls Merlin 2 PCS model MER3700, software used to program and interrogate Abbott implantable medical devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involving medical device software used for implantable device programming. No illnesses or injuries are reported in the source text, but the Class II designation reflects the agency's assessment of potential health risk. The specific hazard is not described in available documentation.
Plain-English summary
The Merlin 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up procedures.
The FDA has issued a Class II recall of this software. Specific information about the defect triggering the recall and any reported patient harm is not available in the provided source documentation.
The recalled product
- Product
- Merlin.net model MN5000 Software
- Category
- Medical Device — Software
- Hazard
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 Merlin.net" v11.7 (MN5000 v7.8.rev6).
- UDI/DI 05414734509732
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.
See all 3 products in this recall →Related recalls
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Similar recalls
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