Device product
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
Z-1525-2015
Product summary
- Event
- Event 71021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 503 units
- Official record key
device-enforcement:Z-1525-2015
Official wording
Reason: The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
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.
Derived failure modes
-
Unknown
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.