Stealth S8 Clinical Software Application — Class I medical device recall Z-1776-2024

Ongoing recall by Medtronic Navigation, Inc., reported 2024-05-15, distributed nationwide. Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distanc

Recall number	`Z-1776-2024`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medtronic Navigation, Inc., Lafayette, CO, United States
Recall initiated	2024-03-26
Classified	2024-05-09
Reported by FDA	2024-05-15
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IS, IT, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NI, NL, NO, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, VN, ZA
Quantity	3,286 applications
Reason classes	software
UPC / GTIN / UDI-DI	`00643169865341`, `00763000063177`, `00763000125295`, `00763000234867`
Model numbers	`9735762`, `CE0344`

Product

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Reason for recall

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

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-1776-2024. 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.