Recall Z-0200-2016 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Medtronic Inc.
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 electrophysio
| Date | Nov 2, 2015 (initiated Sep 29, 2015) |
| Status | Terminated |
| Reason | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. |
| Root cause | Under Investigation by firm |
| Action | Medtronic sales reps began notifying customers on 9/29/2015. Customers were told of the issue and were requested to quarantine and return un-used product. A follow-up Urgent Medical Device Recall letter was hand delivered beginning 10/6/2015. The letter again described the issue, identified affected product and asked that un-used product be returned to Medtronic. A response form was asked to be returned to Medtronic. Customer with questions can contact Medtronic AF Solutions at 888-843-8301 |
| Quantity | 64 units |
| Distribution | Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102588 | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE Medtronic Ablation Frontiers, LLC, Mar 18, 2011 |