Abbott recalls TactiCath Sensor Enabled catheters that may show 'invalid catheter' or 'expired catheter' errors when connected to EnSite Precision Navigation System. Affected units have specific UDI and batch numbers.
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
Abbott is recalling TactiC: Catheter devices that may display error messages when connected to their navigation system. This could lead to incorrect heart mapping during procedures. Affected units have specific UDI and batch numbers.
The catheter may show error messages when connected to the EnSite Precision Navigation System, potentially causing incorrect heart mapping during ablation procedures. This could lead to ineffective treatment or complications if not addressed.
Healthcare professionals using the catheter for heart mapping procedures. Patients are not directly affected as this is a medical device used by doctors.
Check for the UDI code starting with 01)05415067027665(17)230831(10) and batch numbers 8409416, 8409675, or 8410811 on the catheter packaging or label.
If the catheter displays 'invalid catheter' or 'expired catheter' messages when connected to the EnSite Precision Navigation System, stop using it immediately.
The catheter may show 'invalid catheter' or 'expired catheter' messages when connected to the EnSite Precision Navigation System.
Check for the UDI code starting with 01)05415067027665(17)230831(10) and batch numbers 8409416, 8409675, or 8410811 on the catheter packaging or label.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1344-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1344-2022 from Abbott. 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.
