Medtronic Navigation, Inc. recalls StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for…

Recall date

September 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0552-2019

FDA classification

Class I

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY OUS: Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Ba…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.