PENTARAY NAV High-Density Mapping Catheter.
Hazard
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
What You Should Do
Remedy
Recall Notification letter, dated 04/14/2016, and Acknowledgement Form was sent to customers via express mail on 05/17/2017. Instructions included to read and follow Labeling Correction Notice carefully, provide the notice to anyone in the facility that should be aware, sign and return the Acknowledgement Form, and to maintain awareness of the correction.
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Products
PENTARAY NAV High-Density Mapping Catheter.
- Brand
- Biosense Webster, Inc.
- UPC
- Product code (Product Description) (GTIN): D-1282-01-S (NAV, 7FR, F, 4-4-4) (10846835009576), D-1282-02-S (NAV, 7FR, F, 2-6-2) (10846835009583), D-1282-03-S (NAV, 7FR, F, 1-8-1) (10846835009590), D-1282-04-S (NAV, 7FR, D, 4-4-4) (10846835009606), D-1282-05-S (NAV, 7FR, D, 2-6-2) (10846835009613), D-1282-06-S (NAV, 7FR, D, 1-8-1) (10846835009620).
Units Affected
73,796 units total