Reported Mar 13, 2013 · Terminated
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using…
Atricure Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atricure Inc · 6217 Centre Park Drive · West Chester, OH · 45069
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number(s)
MAX1 A000163Lot Number 41865
- Model Number(s)
- Amount recalled
- 5 devices
Where it was sold
Why it was recalled
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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