Z-0211-2018Class II

PENTARAY NAV High-Density Mapping Catheter

Name: Z-0211-2018 PENTARAY NAV High-Density Mapping Catheter
Creator: Biosense Webster, Inc.
Published: 2017-05-17
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2017-05-17 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of PENTARAY NAV High-Density Mapping Catheter on 2017-05-17. FDA classified it as Class II and gives the reason as "Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0211-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-17
Posted: 2017-12-07
Terminated: 2020-12-15
Recalling firm: Biosense Webster Inc
Product: PENTARAY NAV High-Density Mapping Catheter.
Product code: MTD Catheter, Intracardiac Mapping, High-Density Array
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0211-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0211-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07
Z-0212-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07

Product code MTD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)