{"id":"3f427e91-1f4c-4124-978d-8df4335b5cd1","slug":"davinci-single-site-wristed-needle-driver-dislodge-recall-2024","kind":"recall","headline":"Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement","summary":"Intuitive recalled the da Vinci Single-Site Wristed Needle Driver (REF 478115) because the needle driver could dislodge or break, causing uncontrollable instrument movement. 317 units. 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founded 1995, Sunnyvale CA) of the [da Vinci](/models/intuitive-da-vinci) teleoperated surgical robots and the Ion robotic bronchoscopy system; 11,000+ da Vinci installed worldwide.","status":"public (NASDAQ: ISRG)","founded":1995,"hq":"Sunnyvale, California, USA","hqLat":37.3688301,"hqLng":-122.036349,"hqGeocodedAt":"2026-08-05T14:34:41.542Z","hqAddress":null,"hqPrecision":null,"website":null,"fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.sec.gov/Archives/edgar/data/0001035267/000103526726000032/isrg-20260331.htm","title":"Intuitive Form 10-Q (Q1 2026): 11,395 da Vinci installed (1,464 da Vinci 5); 1,041 Ion","sourceName":"SEC EDGAR"},{"url":"https://www.sec.gov/Archives/edgar/data/1035267/000103526726000029/q126ex-991earningsrelease.htm","title":"Intuitive Q1 2026 earnings (procedures +17%; 431 da Vinci placed; revenue $2.77B)","sourceName":"SEC EDGAR"},{"url":"https://www.globenewswire.com/news-release/2024/03/14/2846718/7637/en/Intuitive-Announces-FDA-Clearance-of-Fifth-Generation-Robotic-System-da-Vinci-5.html","title":"Intuitive: FDA clearance of da Vinci 5 (510(k), Mar 14 2024; Force Feedback)","sourceName":"Intuitive (GlobeNewswire)"},{"url":"https://www.therobotreport.com/intuitive-demos-4000-mile-telesurgery-with-da-vinci-5-surgical-robot/","title":"Intuitive demos 4,000-mile telesurgery (investigational, in development)","sourceName":"The Robot Report"}],"keyFacts":[{"label":"Installed base","value":"11,395 da Vinci (1,464 da Vinci 5) + 1,041 Ion (SEC 10-Q, Q1 2026)."},{"label":"Gating events","value":"da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019."},{"label":"Stock listing","value":"NASDAQ: ISRG"},{"label":"Market position","value":"Dominant surgical-robotics maker"},{"label":"da Vinci product type","value":"Teleoperated surgical robot"},{"label":"Ion product type","value":"Robotic bronchoscopy system"},{"label":"Hero image candidate","value":"https://upload.wikimedia.org/wikipedia/commons/7/77/New_Da_Vinci_Xi.jpg (source: Wikimedia Commons, license: CC BY-SA 4.0)"}],"aliases":["Intuitive","ISRG","da Vinci","Intuitive Surgical Inc","da Vinci robot","da Vinci surgical system"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"ISRG","stockExchange":"NASDAQ","secCik":"0001035267","revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-08-05T14:34:41.543Z"},"derived":{"status":"active"},"sources":[{"id":"30ac372b-92e6-4c4f-9584-16811883230f","incidentId":"3f427e91-1f4c-4124-978d-8df4335b5cd1","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=203868","label":null,"publishedAt":null,"notes":null,"title":"FDA Class 2 Recall — Da Vinci Single-Site Wristed Needle Driver","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:55:49.584Z","updatedAt":"2026-07-22T01:55:49.584Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/davinci-single-site-wristed-needle-driver-dislodge-recall-2024","url":"https://registry.deploy.report/incidents/davinci-single-site-wristed-needle-driver-dislodge-recall-2024","headline":"Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement","description":"Intuitive recalled the da Vinci Single-Site Wristed Needle Driver (REF 478115) because the needle driver could dislodge or break, causing uncontrollable instrument movement. 317 units. Source: FDA Class 2 device recall Z-0406-2024, openFDA enforcement / accessdata.fda.gov.","identifier":"3f427e91-1f4c-4124-978d-8df4335b5cd1","datePublished":"2023-10-06T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-fda-database"]}}}