—#149419

Product

Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures.

FDA product code: GAH — Stylet, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot number 151591

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

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

Timeline

Recall initiated: 2016-09-01
Posted by FDA: 2016-10-28
Terminated: 2017-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149419. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.