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U.S. Department of Health and Human Services

Class 2 Device Recall Visualase Body Accessory Kit

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  Class 2 Device Recall Visualase Body Accessory Kit see related information
Date Initiated by Firm September 01, 2016
Date Posted October 28, 2016
Recall Status1 Terminated 3 on March 27, 2017
Recall Number Z-0323-2017
Recall Event ID 75124
Product Classification Stylet, surgical, general & plastic surgery - Product Code GAH
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.
Code Information Lot number 151591
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Tom Reimann
720-890-3200
Manufacturer 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.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action 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.
Quantity in Commerce 100 total units
Distribution Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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