Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | Atricure Inc. The Isolator Transpolar Pen is intended 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. |
|---|---|
| Recall Number | Z-0912-2013 |
| Classification | Class II |
| Code Info | Model Number(s): MAX1 A000163, Lot Number 41865 |
| Product Distributed Qty | 5 devices |
| Reason For Recall | AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. |
Event Detail
| Event Id | 64404 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Atricure Inc |
| City | West Chester |
| State | OH | Country | US |
| Voluntary / Mandated | |
| Recall Initiation Date | 2013-01-14 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide Distribution including the states of MD, PA and TX. |
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