The Recall Desk

FDA (Devices) recall action 85559

BIOSENSE WEBSTER recalled 2 products on 2020-06-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-06-24
Critical
0
Units
435,590

Why these products were recalled

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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
    Distribution
    48 states
  • HighFDA (Devices)··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
    Distribution
    48 states