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.
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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026