Events

Recall of Device Recall Vaxcel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Navilyst Medical, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55786
  • Event Risk Class
    Class 1
  • Event Number
    Z-1876-2010
  • Event Initiated Date
    2010-05-13
  • Event Date Posted
    2010-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91828
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Reason
    Fda testing determined that non-coring needles included in the vaxcel port and vaxcel port with pasv valve may result in coring and resulting septum damage which could lead to patient injury.
  • Action
    Navilyst Medical, Inc. is recalling Vaxcel Ports and Vaxcel Ports with PASV Valve with valid expiration dates worldwide. Navilyst sent "Urgent Medical Device Recall - Immediate Action Required" letter/recall notification packages on May 13, 2010, via Federal Express to 471 domestic consignees; on May 14, 2010, via e-mail to 14 international consignees and to Boston Scientific Corporation (prior owner of the affected products) via facsimile and Federal Express. On June 3, 2010, Navilyst Medical sent Recall Notification Packages on behalf of Boston Scientific Corp. via Federal Express to 182 domestic consignees. The letter instructs the customer to immediately discontinue use of and segregate recalled product, complete and return the reply verification tracking form to fax# 518-742-4450 and package and return the recalled product to the address provided. If you have any question, please call Navilyst Medical, Inc., Customer Service at 1-800-833-9973 or Michael Duerr at 1-518-742-4571.

Device

Device Recall Vaxcel
  • Model / Serial
    Lots 1193953, 1195311, 1198104, 1200700, 1202457, 1204614, 1207340, 1207664, 1214355, 1214650, 1215657, 1216850, 1221191, 1227000, 1228413, 1231143, 1232464, 1235320, 1239041, 1239321, 1240899, 1244264, 1247038, 1248432, 1250527, 1252585, 1257023, 1258103, 1263712, 1265771, 1267691, 1273901, 1277633, 1281030, 1285145, 1288649, 1294480, 1295865, 1296141, 1296709, 1297923, 1300521, 1307356, 1307357, 1307358, 1311034, 1313096, 1313097, 1348374, 1353274, 1355601, 1356197, 1365529, 1367037, 1368843, 1370103, 1372521, 1374541, 1377316, 1377612, 1377844, 1378093, 1378345, 1380085, 1381887, 4000284, 4001732, 4007724, 4014661
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
    Navilyst Medical, Inc
  • Source
    USFDA