FDA recall Z-0832-2019

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-01-22

Report date

2019-02-20

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mason, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2019