Z-1023-2013Class II

20-Pole Eco Cable, Catalog #EM-5050-060

Name: Z-1023-2013 20-Pole Eco Cable, Catalog #EM-5050-060
Creator: Biosense Webster, Inc.
Published: 2013-03-05
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2013-03-05 / Terminated / root cause: manufacturing process

FDA source

Biosense Webster, Inc. began a 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 NAV Eco Catheter... on 2013-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1023-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-05
Posted: 2013-03-28
Terminated: 2013-10-17
Recalling firm: Biosense Webster Inc
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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Biosense Webster sent an Urgent Field Notice Medical Device Letter dated March 5, 2013 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers with questions are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Mon-Friday from 7amto 8pm EST.
Quantity in commerce: 54 units
Distribution: Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1023-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1023-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code DQK

K120550Class IICarto(r) Ep Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc. / cleared 2012-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)