Device 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.
Z-0200-2016
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 72115
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 units
- Official record key
device-enforcement:Z-0200-2016
Official wording
Reason: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Code information: Lot U531
Distribution pattern: Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
Derived failure modes
-
Unknown
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.