St Jude Medical Recalls Merlin PCS Programmer Software for ICM Battery Display Error
St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software display error (incorrect low battery indicator) rather than a direct physiological harm, fitting the criteria for moderate severity involving minor technical issues or low-risk contamination.
Plain-English summary
St Jude Medical Inc. is recalling the Merlin PCS Programmer Software (model 3330) used with the Merlin PCS Programmer (model 3650). This software is used to support implanted Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices.
The recall is due to a software issue where exposure to sub-freezing temperatures during the supply chain caused a transient battery voltage drop in a small number of ICM devices. While this voltage drop is expected behavior for the battery chemistry, it causes the programmer to incorrectly display a low battery indicator even after the voltage returns to normal. The software update serves as the method for delivering the necessary firmware to correct this display error.
The affected software version is 24.0.1 rev 1. The distribution was nationwide across the United States. The firm is advising physicians to update the software on their programmers to ensure accurate battery status readings for their patients' implanted devices.
The recalled product
- Product
- Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new…
- Manufacturer
- St Jude Medical Inc.
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 (1)
- Software Versions: 24.0.1 rev 1
Distribution
Part of a larger recall action
This product is one of 2 recalled by St Jude Medical Inc. 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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