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Medtronic Perfusion Systems recalls Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plas
Recalled June 1, 2022 · FDA recall Z-1131-2022 · Medtronic Perfusion Systems
Hazard
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. · FDA Class II
Units
1236 units
Sold at
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.
Description
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Product
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.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →