Z-0912-2013Class II

Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac...

Name: Z-0912-2013 Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac...
Creator: Atricure Inc
Published: 2013-01-14
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2013-01-14 / Terminated / root cause: manufacturing process

FDA source

Atricure Inc began a recall of Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to... on 2013-01-14. FDA classified it as Class II and gives the reason as "Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0912-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Posted: 2013-03-06
Terminated: 2013-06-11
Recalling firm: AtriCure, Inc.
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.
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Reason for recall: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 5 devices
Distribution: Nationwide Distribution including the states of MD, PA and TX.
Product codes and lots: Model Number(s): MAX1 A000163, Lot Number 41865

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0912-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0912-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-06

Product code OCL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)