# FDA recall Z-0552-2019

> **Medtronic Navigation, Inc.** · Class I · device recall initiated 2018-09-26.

## 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 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.

## Distribution

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, Barbados, Belarus, Belgium, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherland, New Zealand, Nicaragua, Norway, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerl

## Key facts

- **Recall number:** Z-0552-2019
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-26
- **Report date:** 2019-01-09
- **Termination date:** 2024-09-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2019

## Citation

> AI Analytics. FDA recall Z-0552-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0552-2019. Source: US FDA. Licensed CC0.

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