Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atricure Inc. Recalled by Atricure Inc Due to Products from lot no. 41865 may have been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Atricure Inc directly.
Affected Products
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Quantity: 5 devices
Why Was This Recalled?
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Atricure Inc
Atricure Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report