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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81932

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 22, 2019
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

4 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 4

COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002

Z-0829-2019
Recall number
Z-0829-2019
Initiated
January 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
AtriCure, Inc.
Quantity
1288 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

Code information

UDI - 00818354012811 Lot Numbers - All lots within expiry

Distribution pattern

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia

device · product 2 of 4

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001

Z-0830-2019
Recall number
Z-0830-2019
Initiated
January 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
AtriCure, Inc.
Quantity
6176 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

Code information

UDI - none Lot Numbers - All lots within expiry

Distribution pattern

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia

device · product 3 of 4

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

Z-0831-2019
Recall number
Z-0831-2019
Initiated
January 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
AtriCure, Inc.
Quantity
175 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

Code information

UDI - 00818354012828 Lot Numbers - All lots within expiry

Distribution pattern

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia

device · product 4 of 4

COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI

Z-0832-2019
Recall number
Z-0832-2019
Initiated
January 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
AtriCure, Inc.
Quantity
765 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

Code information

UDI - 00818354013016 Lot Numbers - All lots within expiry

Distribution pattern

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia