Recall Z-0212-2018 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
| Date | May 17, 2017 |
| Status | Terminated |
| Reason | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. |
| Root cause | Other |
| Action | 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. |
| 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, Japa |
| FDA record | Open on fda.gov |