St. Jude Medical recalls TactiFlex Ablation Sensor Enabled Catheters (Models A-TFSE-FJ) that may display incorrect model in EnSiteX EP System, causing features to be missing or inverted on display.
When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.
St. Jude Medical is recalling specific TactiFlex Ablation Catheters that may cause the EnSiteX EP System to display the wrong model. This could mean important features don't show up or the catheter image appears upside down during procedures.
When used with the EnSiteX EP System, the catheter may be misidentified as a different model. This causes features specific to the catheter to not appear on the display and may show the catheter image upside down.
Cardiac ablation procedures use this catheter. Patients undergoing these procedures are most at risk if the system displays incorrect information.
Check for model numbers A-TFSE-FJ with 7.5 F shaft and 8F distal section. Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, expiring November 30, 2024.
Verify the model number and lot numbers listed in the recall notice to confirm if your catheter is affected.
The catheter may be misidentified by the EnSiteX EP System as a different model, causing features to not appear or the image to show upside down.
Check for model numbers A-TFSE-FJ with 7.5 F shaft and 8F distal section, and lot numbers 100733391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, expiring November 30, 2024.
The recall notice does not specify a remedy, so contact St. Jude Medical for guidance on next steps.
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-0814-2024 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0814-2024 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.
