Z-0653-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2016
- Initiation Date
- September 22, 2016
- Termination Date
- February 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,263
Product Description
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
Reason for Recall
Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
Distribution Pattern
Worldwide Distribution -- USA, in the following states AL, AR, AZ, CA, CO, CT, GA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, & VA; and, to the countries of Albania, Australia, Belgium, France, Germany, Ireland, Italy, Norway, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.
Code Information
Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture" on the product label as: MM-YYYY, e.g. 02-2016 or earlier.