St Jude Medical recalls Merlin PCS Programmer Software 3330 (model 3650) due to incorrect low battery display after cold exposure. Affected devices may show false low battery warnings even when functional.
The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
St Jude Medical is recalling the Merlin PCS programmer software version 3330 (model 3650) because cold exposure during shipping can cause temporary battery voltage drops that trigger false low battery warnings. This does not affect device safety but may cause confusion for medical staff using the device.
Cold temperatures during shipping can cause temporary battery voltage drops in the device. This triggers a false low battery warning that persists even after the battery recovers to normal levels. The issue does not cause device failure but may lead to confusion about battery status.
Physicians using the Merlin PCS programmer software version 3330 (model 3650) with the specific software version 24.0.1 rev 1 are most at risk. The recall affects a small number of devices that experienced cold exposure during shipping.
Check if you have the Merlin PCS programmer (model 3650) with software version 24.0.1 rev 1. The recall specifically targets devices that were exposed to sub-freezing temperatures during shipping.
Verify your Merlin PCS programmer has software version 24.0.1 rev 1 by checking the device settings.
No, the recall states the issue only causes false low battery warnings and does not affect device safety.
The recall mentions a small number of devices affected by cold exposure during shipping.
No, the device remains safe to use; the issue only causes temporary false warnings.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2335-2018 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2335-2018 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
