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.
Reported: March 13, 2013 Initiated: January 14, 2013 #Z-0912-2013
Product Description
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.
Reason for Recall
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Details
- Recalling Firm
- Atricure Inc
- Units Affected
- 5 devices
- Distribution
- Nationwide Distribution including the states of MD, PA and TX.
- Location
- West Chester, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Atricure Inc. Units affected: 5 devices.
Why was this product recalled? ▼
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2013. Severity: Moderate. Recall number: Z-0912-2013.
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