Biosense Webster, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1525-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

Product Classification:

Class II

Date Initiated: April 17, 2015

Date Posted: May 6, 2015

Recall Number: Z-1525-2015

Event ID: 71021

Reason for Recall:

The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

Status: Terminated

Product Quantity: 503 units

Code Information:

Lot No. 17147443M, 17177237M, 17196045M, 17142745M, 17176185M, 17191133M, 17177957M, 17162927M, 17163734M, 17159129M, 17157116M, 17144954M, 17192170M, 17192723M, 17173428M, 17174967M, 17174968M, 17194186M, 17194707M, 17153400M, 17154595M, 17176186M, 17142888M, 17167809M, 17167282M, 17158235M, 17159407M, 17151134M, 17154141M, 17176477M, 17176478M, 17172465M, 17145731M, 17146665M, 17172058M.

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated