20-Pole Eco Cable — Class II medical device recall Z-1023-2013
Terminated recall by Biosense Webster, Inc., reported 2013-04-03, distributed nationwide. Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connecte
| Recall number | Z-1023-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2013-03-05 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 54 units |
| Lot numbers | P1210, P1220, P1221, P1231 |
| Serial numbers | 1001, 1123, 1148, 120, 132, 134, 136, 1378, 151, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797, 1799, 1802 and 28 more |
| Model numbers | EM-5050-060 |
Product
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Reason for recall
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
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-1023-2013. 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.