{"id":"955a6513-2110-43ba-98b4-92cfbee12f98","slug":"davinci-xi-sureform45-tissue-pushout-bleeding-recall-2022","kind":"recall","headline":"Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding","summary":"Intuitive recalled da Vinci X/Xi SureForm 45 staplers (REF 480445 / 480545 / 480460) because tissue pushout during stapler firing could cause critical bleeding. Distinct failure mode and Z-number from the same-era SureForm staple-fragment recall already recorded. Source: FDA Class 2 device recall Z-0999-2022, openFDA enforcement / accessdata.fda.gov.","occurredAt":"2022-03-17T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T11:10:31.986Z","updatedAt":"2026-06-27T11:10:31.986Z","model":null,"deployment":null,"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 (NASDAQ: ISRG)","founded":1995,"hq":"Sunnyvale, California, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","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"}],"aliases":["Intuitive","ISRG","da Vinci"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-06-28T13:52:14.998Z"},"derived":{"status":"active"},"sources":[],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/davinci-xi-sureform45-tissue-pushout-bleeding-recall-2022","url":"https://registry.deploy.report/incidents/davinci-xi-sureform45-tissue-pushout-bleeding-recall-2022","headline":"Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding","description":"Intuitive recalled da Vinci X/Xi SureForm 45 staplers (REF 480445 / 480545 / 480460) because tissue pushout during stapler firing could cause critical bleeding. Distinct failure mode and Z-number from the same-era SureForm staple-fragment recall already recorded. Source: FDA Class 2 device recall Z-0999-2022, openFDA enforcement / accessdata.fda.gov.","identifier":"955a6513-2110-43ba-98b4-92cfbee12f98","datePublished":"2022-03-17T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","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":0,"primary_source_types":[]}}}