Z-0323-2017Class II

Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit...

Name: Z-0323-2017 Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit...
Creator: Medtronic Navigation, Inc.
Published: 2016-09-01
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-09-01 / Terminated

FDA source

Medtronic Navigation, Inc. began a recall of Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices... on 2016-09-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0323-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-01
Posted: 2016-10-28
Terminated: 2017-03-27
Recalling firm: Medtronic Navigation, Inc
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.
Product code: GAH Stylet, Surgical, General & Plastic Surgery
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 root cause: 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 [email protected] 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.
Product codes and lots: Lot number 151591

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0323-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0322-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-10-28
Z-0323-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-10-28

Product code GAH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)