Medtronic Achieve Cables — Class II medical device recall Z-0200-2016
Terminated recall by Medtronic Inc., reported 2015-11-11, distributed in AR, CA, CO, DC, DE, GA, IA, KY…. 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
| Recall number | Z-0200-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-09-29 |
| Classified | 2015-11-02 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-03-09 |
| Distributed | AR, CA, CO, DC, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, VA |
| Quantity | 64 units |
| Reason classes | sterility |
| Lot numbers | U531 |
| Model numbers | 990066 |
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 for recall
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0200-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.