Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 13, 2013
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.
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Atricure Inc recalled Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tis… - a moderate-severity action.
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tis… was recalled by Atricure Inc in March 13, 2013. Reason: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.. Check the official notice for the remedy. Verify recall #Z-0912-2013 with the FDA Devices before acting.
The recall
Atricure Inc issued this moderate-severity FDA Devices recall-Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling..
- Moderate
- severity level
- 5 units
- affected scope
- Class II
- classification
- March 13, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0912-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0912-2013) was formally reported on March 13, 2013, with the manufacturer initiating the action on January 14, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Atricure Inc is listed as the recalling firm, operating out of West Chester, OH. Federal records list the affected scope as 5 devices.
The documented reason for this recall is: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. Distribution data in the federal record shows the product reached: Nationwide Distribution including the states of MD, PA and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5 devices
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0912-2013 |
| Date reported | March 13, 2013 |
| Date initiated | January 14, 2013 |
| Recalling firm | Atricure Inc |
| Firm location | West Chester, OH |
| Affected scope | 5 devices |
| Distribution | Nationwide Distribution including the states of MD, PA and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0912-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Atricure Inc. Units affected: 5 devices.
Why was this product recalled? ▼
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2013. Severity: Moderate. Recall number: Z-0912-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including the states of MD, PA and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0912-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 13, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.