Biosense Webster, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1023-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 5, 2013

Date Posted: April 3, 2013

Recall Number: Z-1023-2013

Event ID: 64579

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.

Status: Terminated

Product Quantity: 54 units

Code Information:

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.

Distribution Pattern:

Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.

Voluntary or Mandated:

Voluntary: Firm initiated