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.

Recall Insight

This FDA Devices action (record #Z-0200-2016) was formally reported on November 11, 2015, with the manufacturer initiating the action on September 29, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc. is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 64 units.

The documented reason for this recall is: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Distribution data in the federal record shows the product reached: Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.