Device Recall PENTARAY NAV Catheter and PENTARAY NAV ECO Catheter 의 리콜

Recall

67566

Class 2

Z-1176-2014

2014-02-20

2014-03-11

Terminated

United States

2014-10-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125726

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.

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: rkazmi@its.jnj.com; 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.