Device product
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.
Z-0912-2013
Product summary
- Firm
- Atricure Inc
- Event
- Event 64404
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 devices
- Official record key
device-enforcement:Z-0912-2013
Official wording
Reason: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Code information: Model Number(s): MAX1 A000163, Lot Number 41865
Distribution pattern: Nationwide Distribution including the states of MD, PA and TX.
Derived failure modes
-
Unknown
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.