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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75178

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

Open FDA event record

Event summary

Timeline bucket
September 22, 2016
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

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Z-0377-2017
Recall number
Z-0377-2017
Initiated
September 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
AtriCure, Inc.
Quantity
298

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for a component failure of the device which could necessitate medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for a component failure of the device which could necessitate medical intervention.

Code information

Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773

Distribution pattern

Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland