Manufacturer
31 recalls in our database name Biosense Webster, Inc. as the manufacturing or recalling firm.
Of the 31 recalls from Biosense Webster, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (19%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Biosense Webster is recalling ThermoCool SmartTouch Navigation Catheters to provide additional labeling for safe and effective use.
Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.
Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.
Biosense Webster is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco because incorrect calibration causes the CARTO 3 System to display them as 10-Pole devices.
Biosense Webster is recalling 54 units of the 20-Pole Eco Cable because incorrect calibration prevents the connected catheter from being recognized by the system.
Biosense Webster is recalling 71 CARTO 3 V1.05 systems because a potential hazard may occur when used with Bloom EP Stimulators and other electrophysiology equipment.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Biosense Webster (United States)
company in Diamond Bar, United States
Source: Wikidata (Q30264019), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.