{"id":"c1f9d75c-99c1-483e-ae90-b58ba27f1bad","slug":"auris-monarch-aspirating-biopsy-needle-breakage-recall-2020","kind":"recall","headline":"Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage","summary":"Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.","occurredAt":"2019-04-19T00:00:00.000Z","reviewStatus":"reviewed","modelId":"fec634ea-8227-4fba-8acc-695f3728a469","deploymentId":null,"companyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":158,"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":"2026-06-27T11:10:33.691Z","updatedAt":"2026-08-09T05:24:01.599Z","model":{"id":"fec634ea-8227-4fba-8acc-695f3728a469","companyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","modelName":"Monarch Platform","slug":"auris-health-monarch","description":"The Auris Health Monarch Platform is a robotic-assisted bronchoscopy system cleared by the FDA in March 2018, enabling physicians to navigate further into the lung for peripheral pulmonary lesion diagnosis and biopsy than is possible with conventional bronchoscopes. The system uses a 10-DOF bronchoscope-and-sheath design with electromagnetic navigation, an outer sheath of 6.0 mm diameter, an inner scope of 4.4 mm, and a 2.1 mm working channel. Auris Health was acquired by Johnson and Johnson for $3.4 billion in 2019 and the Monarch is now commercialised by J&J MedTech.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"research","lifecycleState":"active","supersededByModelId":null,"specs":{"dof":"10","fda_clearance":"March 2018","clearance_body":"FDA","procedure_types":"bronchoscopy","working_channel_mm":"2.1","inner_scope_diameter_mm":"4.4","outer_sheath_diameter_mm":"6.0"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.jnjmedtech.com/en-US/products/robotics/monarch-platform/bronchoscopy/","label":"MONARCH Platform | J&J MedTech US","title":"MONARCH Platform | J&J MedTech US","mediaType":"article"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7330790/","label":"Robotic bronchoscopy for pulmonary lesions - PMC","title":"Robotic bronchoscopy for pulmonary lesions - PMC","mediaType":"article"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"DOF","value":"10"},{"label":"Outer sheath diameter","value":"6.0 mm"},{"label":"Inner scope diameter","value":"4.4 mm"},{"label":"Working channel","value":"2.1 mm"},{"label":"FDA clearance date","value":"March 2018"}],"createdAt":"2026-06-27T21:36:19.984Z","updatedAt":"2026-07-12T04:24:54.291Z","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":null,"company":{"id":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","name":"Auris Health","slug":"auris-health","description":"American surgical robotics company developing the Monarch Platform for robotic-assisted bronchoscopy. Founded by Frederic Moll (also founder of [Intuitive surgical](/companies/intuitive-surgical)). Acquired by Johnson & Johnson for $3.4B in 2019, now part of J&J MedTech.","status":"subsidiary","founded":2007,"hq":"Redwood City, California, USA","hqLat":37.4863239,"hqLng":-122.232523,"hqGeocodedAt":"2026-08-05T14:20:33.479Z","hqAddress":null,"hqPrecision":null,"website":"aurishealth.com","fundingTotal":null,"type":"hardware","roles":["robot_maker"],"reviewStatus":"reviewed","heatIndex":50,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://techcrunch.com/2019/02/13/jj-spends-3-4-billion-in-cash-for-auris-healths-lung-cancer-diagnostics-and-surgical-robots/","title":"J&J acquires Auris Health for $3.4B","date_accessed":"2026-06-23"}],"keyFacts":[{"label":"Founder","value":"Frederic Moll (also founded Intuitive Surgical)"},{"label":"HQ","value":"Redwood City, California, USA"},{"label":"Founded","value":"2007 (as Auris Surgical Robots)"},{"label":"Acquisition","value":"Acquired by Johnson & Johnson for $3.4B in February 2019 — now part of J&J MedTech"},{"label":"Product","value":"Monarch Platform — first flexible robotically-assisted platform for bronchoscopy"},{"label":"FDA clearance","value":"Monarch Platform FDA-cleared for robotic-assisted bronchoscopy (2018)"},{"label":"Monarch Quest","value":"FDA cleared Monarch Quest for enhanced robotic-assisted bronchoscopy (2025)"},{"label":"Incidents","value":"7 incidents on file — already recorded in registry"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-24T01:51:54.280Z","updatedAt":"2026-08-21T22:28:54.393Z"},"derived":{"status":"active"},"sources":[{"id":"68fafe31-328e-4973-a5f7-f7bf4a41b993","incidentId":"c1f9d75c-99c1-483e-ae90-b58ba27f1bad","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Auris&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100","label":null,"publishedAt":null,"notes":null,"title":"FDA Medical Device Recalls — Auris Health Monarch (2017-2026)","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:56:19.298Z","updatedAt":"2026-07-22T01:56:19.298Z"},{"id":"5d2da61d-08e5-4fcc-97a3-0dfb40fe1175","incidentId":"c1f9d75c-99c1-483e-ae90-b58ba27f1bad","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=172660","label":null,"publishedAt":null,"notes":null,"title":"Class 2 Device Recall: Monarch Aspirating Biopsy Needle","sourceName":"U.S. Food and Drug Administration","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-09-29T20:46:29.256Z","updatedAt":"2026-09-29T20:46:29.256Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/auris-monarch-aspirating-biopsy-needle-breakage-recall-2020","url":"https://registry.deploy.report/incidents/auris-monarch-aspirating-biopsy-needle-breakage-recall-2020","headline":"Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage","description":"Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.","identifier":"c1f9d75c-99c1-483e-ae90-b58ba27f1bad","datePublished":"2019-04-19T00:00:00.000Z","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":2,"primary_source_types":["primary-fda-database"]}}}