FDA-Device2015-11-11Class II
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.
Medtronic Inc.
Hazard
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Sold states
Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
Affected count
64 units
Manufactured in
8200 Coral Sea St Ne, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2016Don't want to check this manually?
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