FDA Device recall Z-1023-2013
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…
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of 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… by Biosense Webster, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1023-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-05 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biosense Webster |
| Distribution | US |
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
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.
Identifiers
| code_info | Impacted serial Numbers: 120, 132, 134,136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424,…Impacted serial Numbers: 120, 132, 134,136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424, 919, 953, 954, 960, 963, 968, 970, 977, 980, 993, 998, 1001, 1123, 1148, 1378, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797, 1799, 1802, 1803, 1804, 1805. Lot Numbers: P1210, P1220, P1221, P1231. |
|---|
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-1023-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.