Company: Medtronic Navigation, Inc.
Date of Enforcement Report: 12/29/2018
Class I:

PRODUCT

StealthStation Cranial and Synergy Cranial Depth Gauge:

StealthStation Cranial Optical Pocket Guide – Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.

Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc

Recall Number: Z-0552-2019

REASON

An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

RECALLING FIRM/MANUFACTURER

Medtronic Navigation, Inc., Louisville, CO on 9/26/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5487

DISTRIBUTION
Nationwide and Internationally