The Recall Desk

FDA (Devices) recall action 73862

Biosense Webster, Inc. recalled 2 products on 2016-05-11

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
2016-05-11
Critical
0
Units
73,584

Why these products were recalled

Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.

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.

1–2 of 2

  • ModerateFDA (Devices)··2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray NAV High-Density Mapping Catheters to clarify contraindication language regarding patients with prosthetic valves.

    Product
    Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie.,
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray Catheters to clarify contraindication language regarding patients with prosthetic valves in the product labeling.

    Product
    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart,
    Category
    Distribution
    0 states