The Recall Desk

Manufacturer

BIOSENSE WEBSTER

2 recalls in our database name BIOSENSE WEBSTER as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2020-06-24

Of the 2 recalls from BIOSENSE WEBSTER we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

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.

1–2 of 2

  • HighFDA (Devices)·Z-2372-2020·2020-06-24

    Biosense Webster PENTARAY NAV Mapping Catheter Recall for Entrapment Risk

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the cardiac valvular apparatus during use.

    Product
    PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2020·2020-06-24

    Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the heart's valves during use.

    Product
    PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

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

Country
United States
Founded
1993

Official website

Source: Wikidata (Q30264019), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.