FDA Device recall Z-0200-2016
Medtronic Achieve Cables, model 990066
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Medtronic Achieve Cables, model 990066 by Medtronic, citing 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0200-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-29 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic |
| Distribution | AR, CA, CO, DC, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, VA |
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.
Reason
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Identifiers
| code_info | Lot U531 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0200-2016%22
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