Class II — Atricure Inc
| Recalling firm | ATRICURE, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. |
| 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. |
| Quantity | 5 devices |
| Distribution | Nationwide Distribution including the states of MD, PA and TX. |
| Initiated | 2013-01-14 |
| Classified | 2013-03-06 |
| Terminated | 2013-06-11 |
| Recall number | Z-0912-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atricure Inc (Z-0912-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64404/
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