Recall Z-0552-2019— Medtronic Navigation, Inc.

Name: FDA recall Z-0552-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-26

Class I · Terminated

Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2018-09-26, terminated 2024-09-05. It names 2 FDA 510(k) clearances: K153660, K150216. 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.. 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: Medtronic Navigation, Inc.
Classification: Class I
Status: Terminated
Initiated: 2018-09-26
Terminated: 2024-09-05
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K153660 — StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.·cleared 2016-09-14
K150216 — Synergy CranialMedtronic Navigation, Inc.·cleared 2015-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.