Devices

Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,

Model / Serial
Catalog # D7R20P14CT
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
Product Description
ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # || D7R20P14CT || The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
Manufacturer
Biosense Webster, Inc.
1 Event
- Recall of Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,

Manufacturer

Biosense Webster, Inc.

Manufacturer Address
Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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