Recall Z-0912-2013— Atricure Inc
Class II · Terminated
Class II FDA medical device recall by Atricure Inc, initiated 2013-01-14, terminated 2013-06-11. It names 2 FDA 510(k) clearances: K061593, K050459. 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.. Reason: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling..
- Recalling firm
- Atricure Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-14
- Terminated
- 2013-06-11
- Firm location
- West Chester, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K061593 — ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
- K050459 — ATRICURE ISOLATOR TRANSPOLAR PEN
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.