Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packa

FDA device recall Z-0322-2017 · posted 2016-10-28 · Terminated

Recall details

Recalling firm

Medtronic Navigation, Inc.

Reason for recall

Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.

Action taken

Medtronic sent an Urgent Medical Device Recall letter dated September 2, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their stock for the affected product and if any are found contact Medtronic to arrange for a no charge replacement. Customers were asked to complete the Customer Confirmation form attached to the letter and return it to Medtronic at RS.NavFCA@medtronic.com or by Fax to 651-367-7075. Customers with questions were instructed to contact Medtronic Technical Services at 1-800-595-9709. For questions regarding this recall call 720-890-3200.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

GAH

Quantity affected

100 total units

Distribution

Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.

Date initiated

2016-09-01

Date posted

2016-10-28

Date terminated

2017-03-27

Location

Louisville, CO