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.
This recall has been terminated (originally issued March 6, 2013).
- Company
- Atricure Inc
- Recall Initiated
- January 14, 2013
- Posted
- March 6, 2013
- Terminated
- June 11, 2013
- Recall Number
- Z-0912-2013
- Quantity
- 5 devices
- Firm Location
- Chester, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Distribution
Nationwide Distribution including the states of MD, PA and TX.
Lot / Code Info
Model Number(s): MAX1 A000163, Lot Number 41865
Root Cause
Employee error
Action Taken
AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.