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.
This recall has been terminated (originally issued October 28, 2016).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- September 1, 2016
- Posted
- October 28, 2016
- Terminated
- March 27, 2017
- Recall Number
- Z-0323-2017
- Quantity
- 100 total units
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
Lot / Code Info
Lot number 151591
Root Cause
Mixed-up of materials/components
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.