Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using
FDA device recall Z-0912-2013 · posted 2013-03-06 · Terminated
Recall details
- Recalling firm
- Atricure Inc
- Reason for recall
- Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
- Action taken
- AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- OCL
- Quantity affected
- 5 devices
- Distribution
- Nationwide Distribution including the states of MD, PA and TX.
- Date initiated
- 2013-01-14
- Date posted
- 2013-03-06
- Date terminated
- 2013-06-11
- Location
- West Chester, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 (K061593) | AtriCure, Inc. | 2006-07-12 |
| ATRICURE ISOLATOR TRANSPOLAR PEN (K050459) | AtriCure, Inc. | 2005-06-13 |