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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64404

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 14, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Atricure Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0912-2013
Recall number
Z-0912-2013
Initiated
January 14, 2013
Classification
Class II
Status
Terminated
Recalling firm
Atricure Inc
Quantity
5 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.

Code information

Model Number(s): MAX1 A000163, Lot Number 41865

Distribution pattern

Nationwide Distribution including the states of MD, PA and TX.