Recall Z-0323-2017
Medtronic Navigation, Inc. · initiated September 1, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number 151591
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: 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.
Details
- Recall number
- Z-0323-2017
- Initiated
- September 1, 2016
- Posted by FDA
- October 28, 2016
- Terminated
- March 27, 2017
- Product code
- GAH – Stylet, Surgical, General & Plastic Surgery
- Quantity
- 100 total units
- Distribution
- Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
- Recalling firm
- Medtronic Navigation, Inc., Louisville, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0322-2017 Class II | Visualase Visualization Stylets PN 020-2301. The individual components within the…Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and… | 09/01/2016Terminated |