Recall Z-0912-2013 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Atricure Inc
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
| Date | Mar 6, 2013 (initiated Jan 14, 2013) |
| Status | Terminated |
| Reason | Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. |
| Root cause | Employee error |
| Action | 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 rev |
| Quantity | 5 devices |
| Distribution | Nationwide Distribution including the states of MD, PA and TX. |
| FDA record | Open on fda.gov |