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