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Biosense Webster, Inc. recalls PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205
Recalled March 19, 2014 · FDA recall Z-1176-2014 · Biosense Webster
Hazard
Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft. · FDA Class II
Units
15,672 units total (12,804 units in US)
Sold at
US Nationwide Distribution.
Description
Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft.
Product
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. 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 or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →