Recall Z-0212-2018

Biosense Webster, Inc. · initiated May 17, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

PENTARAY NAV High-Density Mapping Catheter.

Codes / lots: Product code (Product Description) (GTIN): D-1282-07-S (NAV ECO 7FR, F, 4-4-4) (10846835012217), D-1282-08-S (NAV ECO 7FR, F, 2-6-2) (10846835012224), D-1282-09-S (NAV ECO 7FR, F, 1-8-1) (10846835012231), D-1282-10-S (NAV ECO 7FR, D, 4-4-4) (10846835012248), D-1282-11-S (NAV ECO 7FR, D, 2-6-2) (10846835012255), D-1282-12-S (NAV ECO 7FR, D, 1-8-1) (1846835012262).

Reason for recall

Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

FDA-determined cause: Other

Action taken

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.

Details

Recall number
Z-0212-2018
Initiated
May 17, 2017
Terminated
December 15, 2020
Product code
MTD – Catheter, Intracardiac Mapping, High-Density Array
Quantity
73,796 units total
Distribution
Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New…
Recalling firm
Biosense Webster, Inc., Irwindale, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0211-2018 Class IIPENTARAY NAV High-Density Mapping Catheter.Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters… 05/17/2017Terminated