St Jude Medical recalls Confirm Rx Insertable Cardiac Monitor Model DM3500 due to temporary battery voltage drop causing incorrect low battery display. No action needed for safety.
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 a small number of Confirm Rx Insertable Cardiac Monitors (Model DM3500) that may show a false low battery warning after exposure to cold temperatures during shipping. This is a temporary display issue that does not affect device function or patient safety.
During shipping in sub-freezing temperatures, some Confirm Rx Model DM3500 devices experienced a temporary battery voltage drop. This causes the device to incorrectly display a low battery warning even after the battery returns to normal operation. The device itself remains functional and does not pose a safety risk.
Patients with St Jude Medical Confirm Rx Insertable Cardiac Monitors (Model DM3500) who received the device during shipping in sub-freezing temperatures. The risk is minimal as the device continues to function normally.
Check if your device has the model number DM3500 and the serial numbers listed in the recall notice (3183655 through 3204636). The device is indicated for monitoring cardiac symptoms in patients with unexplained symptoms or cardiac arrhythmias.
Verify if your device has the model number DM3500 and one of the listed serial numbers (3183655 through 3204636).
No, the device continues to function normally. The temporary display issue does not affect patient safety or device operation.
No action is required. The device remains safe to use as the temporary display issue does not cause harm.
This is a temporary display issue that resolves itself. The device will show normal battery levels once the temperature returns to normal.
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-2334-2018 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2334-2018 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.
