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Medtronic Inc. recalls Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the condu
Recalled November 11, 2015 · FDA recall Z-0200-2016 · Medtronic
Hazard
64 units of Achieve Electrical Cables were shipped with a potential sterility breach. · FDA Class II
Units
64 units
Sold at
Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
Description
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Product
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.
Manufacturer(s)
Medtronic Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →