St. Jude Medical recalls Merlin PCS 3650 Software Upgrade Kit (REF 3330) due to potential incorrect energy settings during device programming, which may not alert users to retained values.
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
St. Jude Medical is recalling the Merlin PCS 3650 Software Upgrade Kit (REF 3330) because software anomalies could cause the device to use incorrect energy levels without alerting users. This may lead to improper device programming if non-applicable shock energy values are selected.
The software may retain a previously programmed energy level even when a non-applicable shock energy value is selected. This means users won't be alerted that the selected value was not retained, potentially causing incorrect device programming.
Healthcare professionals using the Merlin PCS 3650 Software Upgrade Kit with affected serial numbers or St. Jude Medical implantable devices. Those programming devices without verifying energy settings are at higher risk.
Check for the Merlin PCS 3650 Software Upgrade Kit (REF 3330) with serial numbers listed in Attachment B.1 Programmers or devices listed in Attachment B.2 Devices. The software version is 24.6.1 for affected units.
Verify the software version is 24.6.1 for affected units by checking the device label.
Compare your programmer's serial number with the list in Attachment B.1 Programmers to confirm if it is affected.
The affected software version is 24.6.1 for the Merlin PCS 3650 Software Upgrade Kit.
Check your programmer's serial number against the list in Attachment B.1 Programmers provided in the recall notice.
If your device is not listed in Attachment B.2 Devices, it is not affected by this recall.
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-1700-2020 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1700-2020 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.
