FDA-Device2022-06-01Class II
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
Medtronic Perfusion Systems
Hazard
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, Switzerland.
Affected count
1236 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2022Don't want to check this manually?
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