Z-1176-2014Class II

PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202...

Name: Z-1176-2014 PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202...
Creator: Biosense Webster, Inc.
Published: 2014-02-20
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2014-02-20 / Terminated / root cause: manufacturing process

FDA source

Biosense Webster, Inc. began a recall of PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211... on 2014-02-20. FDA classified it as Class II and gives the reason as "Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1176-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-20
Posted: 2014-03-11
Terminated: 2014-10-24
Recalling firm: Biosense Webster Inc
Product: PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Product code: MTD Catheter, Intracardiac Mapping, High-Density Array
Reason for recall: Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Biosense Webster, sent an "URGENT FIELD SAFETY NOTICE MEDICAL DEVICE-VOLUNTARY FIELD RECALL (REMOVAL)" letter dated February 18, 2014 to all customers who purchased the PentaRay Nav Catheter. The letter describes the product, the problems identified and the actions to be taken. The customers were instructed to read the "Description of the Problem" section carefully; immediately identify and set aside all affected lots; maintain a copy of this letter with the affected PentaRay NAV Catheters until all units are returned to Biosense Webster; complete and return the Voluntary Field Removal Certification form via mail to: Biosense Webster, Inc., Attn: Field Action Coordinator, 15715 Arrow Highway, Irwindale, CA 91706, Fax to: 909-839-8514 or email to: [email protected]; arrange for return of all affected units you may have in your inventory; pass on this notice to anyone in your facility that needs to be informed, and if any of the affected product have been forwarded to another facility, contact that facility and arrange for the return. Customers with questions related to the information provided in the customer notification, are instructed to contact their Biosense Webster sales representative or call (866)473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions related to the Acknowledgement form and its return, are instructed to contact the Field Action Coordinator at (909) 839-8468. Biosense Webster expanded the recall on 5/1/14 by sending a customer notification letter to all customers on 5/2/14 to include all product lots of the Pentaray Nav Catheter (Catalog No: D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211). The letter provides important information about the affected products and instructions on how the customers can return the affected products to Biosense Webster.
Quantity in commerce: 15,672 units total (12,804 units in US)
Distribution: US Nationwide Distribution.
Product codes and lots: Lot Numbers: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1176-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1176-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-11

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)