Severity
Critical
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 20
Reported: January 9, 2019 Initiated: September 26, 2018 #Z-0552-2019 5487 impacted systems units
Medtronic Navigation, Inc. issued this FDA Devices recall on January 9, 2019. Classified as Critical severity (Class I). Approximately 5487 impacted systems units are affected. The recall was issued because: An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, wh…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0552-2019) was formally reported on January 9, 2019, with the manufacturer initiating the action on September 26, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Medtronic Navigation, Inc. is listed as the recalling firm, operating out of Louisville, CO. Federal records indicate 5487 impacted systems units are affected.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
5487 impacted systems
Related Recalls
6
6 from same agency
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.
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 5487 impacted systems
- 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, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam
- Location
- Louisville, CO
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0552-2019 |
| Date reported | January 9, 2019 |
| Date initiated | September 26, 2018 |
| Recalling firm | Medtronic Navigation, Inc. |
| Units affected | 5487 impacted systems |
| 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product 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.. Recalled by Medtronic Navigation, Inc.. Units affected: 5487 impacted systems.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 9, 2019. Severity: Critical. Recall number: Z-0552-2019.
Where was the recalled product distributed? ▼
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, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0552-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).