Medtronic Inc. recalls Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the condu…

Recall date

September 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0200-2016

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.

Why it was recalled

64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.