Atricure Inc — Class II medical device recall Z-0912-2013
Terminated recall by Atricure Inc, reported 2013-03-13, distributed nationwide. Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
| Recall number | Z-0912-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atricure Inc, West Chester, OH, United States |
| Recall initiated | 2013-01-14 |
| Classified | 2013-03-06 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 5 devices |
| Reason classes | labeling |
| Lot numbers | 41865 |
| Model numbers | 41865, A000163, MAX1 |
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 for recall
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0912-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.