{"id":"0906f54e-ce85-43e5-aac0-fd2e010d9175","slug":"davinci-mega-needle-driver-frayed-grip-cable-recall-2026","kind":"recall","headline":"Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables","summary":"Intuitive recalled the da Vinci S/Si Mega Needle Driver (REF 420194) over broken or frayed grip cables on the reusable instrument that could cause loss of instrument control. 7,819 units. Source: FDA Class 2 device recall Z-1698-2026, openFDA enforcement / accessdata.fda.gov.","occurredAt":"2025-12-09T00:00:00.000Z","reviewStatus":"reviewed","modelId":"0e2f5d6f-8ce6-4726-9301-d438ecf732bc","deploymentId":"352ff92b-8433-4b12-bbaf-fdb2135058b6","companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":7819,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T11:10:31.752Z","updatedAt":"2026-08-09T05:24:01.599Z","model":{"id":"0e2f5d6f-8ce6-4726-9301-d438ecf732bc","companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","modelName":"Ion Endoluminal System","slug":"intuitive-ion","description":"Intuitive Surgical's Ion Endoluminal System is a robotic-assisted bronchoscopy platform for minimally invasive biopsy of peripheral lung nodules. It uses an ultra-thin, shape-sensing maneuverable catheter with PlanPoint CT-based airway planning to reach lesions deep in the peripheral lung. FDA 510(k) cleared in February 2019 and commercially deployed across US hospitals, with subsequent AI and advanced-imaging integration clearances.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"pathway":"FDA 510(k) cleared 2019-02-20 (clearance number not corroborated to bar)","modality":"shape-sensing robotic-assisted bronchoscopy","planning":"PlanPoint CT-based airway planning","indication":"peripheral lung nodule biopsy"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://isrg.intuitive.com/news-releases/news-release-details/u-s-fda-grants-clearance-ion-intuitive/","title":"FDA grants clearance for Ion by Intuitive","sourceName":"Intuitive Surgical (official)"},{"url":"https://www.sages.org/publications/tavac/intuitive-ion-endoluminal-system/","title":"Ion Endoluminal System TAVAC","sourceName":"SAGES"},{"url":"https://www.intuitive.com/en-us/products-and-services/ion","title":"Ion Robotic Bronchoscopy","sourceName":"Intuitive"}],"aliases":["Ion","Ion Endoluminal System"],"collisionRisk":"low","reviewNote":"Reviewed 2026-07-14: source-gated bulk flip (non-empty sources[]). Ben-approved.","manufacturerTermForTeleop":null,"keyFacts":[{"label":"FDA clearance","value":"FDA 510(k) cleared in February 2019"},{"label":"Ion robotic bronchoscopy","value":"Intuitive describes Ion as a robotic-assisted, software-controlled platform for minimally invasive navigation and biopsy of the pulmonary tract ([Ion Robotic Bronchoscopy](https://www.intuitive.com/en-us/products-and-services/ion))","sourceUrl":"https://www.intuitive.com/en-us/products-and-services/ion"},{"label":"Ion shape sensing and planning","value":"Intuitive says Ion uses an ultrathin articulating catheter with shape-sensing technology and PlanPoint software to support navigation using 3D airway maps from CT scans ([Ion Robotic Bronchoscopy](https://www.intuitive.com/en-us/products-and-services/ion))","sourceUrl":"https://www.intuitive.com/en-us/products-and-services/ion"},{"label":"Ion page prints model IF1000 and 18 lung segments","value":"Intuitive's Ion page prints the Ion endoluminal system as Model IF1000 and says the ultrathin catheter can reach small lesions in all 18 segments of the lung. The stored qualitative bronchoscopy sentence is not this model-number cell ([Ion](https://www.intuitive.com/en-us/products-and-services/ion))."},{"label":"Ion page prints more than 100,000 biopsies","value":"The same page prints more than 100,000 Ion biopsies completed, and says shape sensing measures the catheter's shape 100s of times per second. Those cells are not the stored PlanPoint sentence ([Ion](https://www.intuitive.com/en-us/products-and-services/ion))."}],"createdAt":"2026-06-05T17:43:05.364Z","updatedAt":"2026-10-04T02:22:25.590Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":{"id":"352ff92b-8433-4b12-bbaf-fdb2135058b6","modelId":"45105ba4-1c1f-4121-9ad4-bb912db1dcfc","versionId":null,"locationId":"84179297-6783-4778-b888-3c681f25e29b","operatorId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","ownerId":null,"slug":"da-vinci-5-ku-ansan-korea","status":"operational","firstSeen":"2024-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":1,"tasksPerformed":["surgical_assistance"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"small_2_10","siteEnvironment":"indoor","operatorType":"customer_deployed","sourceQualityTier":3,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.news-medical.net/news/20260708/KU-Ansan-Hospital-introduces-the-Da-Vinci-5-robotic-system-to-boost-surgical-precision.aspx","title":"KU Ansan Hospital introduces the Da Vinci 5 robotic system"}],"notes":"KU Ansan Hospital introduces da Vinci 5 robotic surgical system in South Korea. Features force feedback for tactile force perception.","keyFacts":[{"label":"Hospital","value":"KU Ansan Hospital, South Korea"},{"label":"Feature","value":"Force feedback (tactile perception)"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"pilot_lt10","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-09T23:52:11.288Z","updatedAt":"2026-08-14T13:33:23.512Z"},"company":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","name":"Intuitive Surgical","slug":"intuitive-surgical","description":"Dominant surgical-robotics maker (NASDAQ: ISRG; 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","founded":1995,"hq":"Sunnyvale, California, USA","hqLat":37.3688301,"hqLng":-122.036349,"hqGeocodedAt":"2026-08-05T14:34:41.542Z","hqAddress":null,"hqPrecision":null,"website":"https://intuitivesurgical.com","fundingTotal":"231000000","type":"both","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":75,"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)"},{"label":"Manufacturing","value":"Vertically integrated — manufactures da Vinci Xi, SP, and 5 systems in-house at Sunnyvale campus (surgeon console, patient side cart, instruments). 99%+ uptime."}],"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":"2026-08-22T03:20:46.710Z"},"derived":{"status":"active"},"sources":[{"id":"0096d945-740b-4f6c-a10f-43af06485d8b","incidentId":"0906f54e-ce85-43e5-aac0-fd2e010d9175","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=218537","label":null,"publishedAt":null,"notes":null,"title":"FDA Class 2 Device Recall — da Vinci S/Si Mega Needle Driver (Z-1698-2026)","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:40:15.252Z","updatedAt":"2026-07-22T01:40:15.252Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/davinci-mega-needle-driver-frayed-grip-cable-recall-2026","url":"https://registry.deploy.report/incidents/davinci-mega-needle-driver-frayed-grip-cable-recall-2026","headline":"Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables","description":"Intuitive recalled the da Vinci S/Si Mega Needle Driver (REF 420194) over broken or frayed grip cables on the reusable instrument that could cause loss of instrument control. 7,819 units. Source: FDA Class 2 device recall Z-1698-2026, openFDA enforcement / accessdata.fda.gov.","identifier":"0906f54e-ce85-43e5-aac0-fd2e010d9175","datePublished":"2025-12-09T00:00:00.000Z","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"]}}}