FDA Device recall Z-0912-2013
Atricure Inc., Max1 Isolator Transpolar Pen
- FDA Device
- Class II
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class II recall of Atricure Inc., Max1 Isolator Transpolar Pen by Atricure, citing products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0912-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-14 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Atricure |
| Distribution | US |
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.
Identifiers
| code_info | Model Number(s): MAX1 A000163, Lot Number 41865 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0912-2013%22
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