Skip to content

PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV… recallZ-1176-2014 · Biosense Webster, Inc. · initiated Feb 20, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number
Z-1176-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 20, 2014
Posted by the FDA
Mar 11, 2014
Recalling firm
Biosense Webster, Inc.
Quantity
15,672 units total (12,804 units in US)
Product code
MTD
FDA submissions
K120425, K123837
Distribution
US Nationwide Distribution.

Product description

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.

Code information (models, lots, serial numbers)

Lot Numbers: All Lots

Other devices under the same FDA submission

12 devices cleared under K120425, K123837 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page