AtriCure, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0829-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 22, 2019

Date Posted: February 20, 2019

Recall Number: Z-0829-2019

Event ID: 81932

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.

Status: Terminated

Product Quantity: 1288 units

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

Voluntary or Mandated:

Voluntary: Firm initiated