StealthStation Cranial and Synergy Cranial Depth Gauge:… — Class I medical device recall Z-0552-2019
Terminated recall by Medtronic Navigation, Inc., reported 2019-01-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial sof
| Recall number | Z-0552-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2018-09-26 |
| Classified | 2018-12-29 |
| Reported by FDA | 2019-01-09 |
| Terminated | 2024-09-05 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, IE, IL, IN, IQ, IS, IT, JO, JP, KR, LB, LK, LT, LU, LV, MA, MX, MY, NI, NO, NP, NZ, PE, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 5,487 impacted |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00613994231031, 00613994408174, 00613994467102, 00613994467126, 00613994546081, 00613994792884, 00613994944986, 00643169037946, 00643169038110, 00643169192140, 00643169332645, 00643169353305, 00643169481268, 00643169481275, 00643169490475, 00643169490482, 00643169502611, 00643169503311, 00643169505759, 00643169505766, 00643169505773, 00643169505780, 00643169505797, 00643169510531, 00643169510548 and 37 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0552-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.