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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76017

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

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Event summary

Timeline bucket
November 30, 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 - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.

Z-1148-2017
Recall number
Z-1148-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Recalling firm
AtriCure, Inc.
Quantity
464 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A complaint of the PRO2 jaw breaking prior to surgery being performed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A complaint of the PRO2 jaw breaking prior to surgery being performed.

Code information

Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418

Distribution pattern

Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI. Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom.