Terminated

PENTARAY NAV High-Density Mapping Catheter.

FDA Recall Z-0211-2018 · Posted None

Recalling FirmBiosense Webster, Inc.

Recall StatusTerminated

Product CodeMTD

Date Initiated2017-05-17

Date Terminated2020-12-15

Product Quantity73,796 units total

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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 Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123837PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc. · 2013-03-05 K120425PENTARAY NAV HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc. · 2012-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.