{"id":"ebbc656d-245e-44ef-a375-65a2e63bac52","slug":"intuitive-surgical-davinci-sureform-stapler-recall-2026-03","kind":"recall","headline":"Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death","summary":"In March 2026, Intuitive Surgical recalled the gray reload cartridges for its da Vinci 8 mm SureForm 30 curved-tip stapler after incomplete staple line formation on blood vessels caused dangerous bleeding. As of late February 2026, the company reported four serious injuries and one patient death. Intuitive notified surgeons on March 11 to stop using gray reloads and switch to alternatives; the FDA amplified the issue through its early-alert program.","occurredAt":"2026-03-11T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"critical","rootCauseCategory":"design_defect","rootCauseDetail":"Incomplete staple line formation on blood vessels with da Vinci SureForm 30 gray reload cartridges could cut tissue and expose the inside of the blood vessel, causing dangerous bleeding potentially requiring conversion to open surgery.","affectedUnitsCount":1,"affectedUnitsBasis":"exact","remediationStatus":"in_progress","regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-07-18T22:25:08.999Z","updatedAt":"2026-07-18T22:25:08.999Z","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","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,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-07-18T21:05:44.618Z"},"derived":{"status":"active"},"sources":[{"id":"c3e0d912-09c0-4a45-a47e-fe4999651413","incidentId":"ebbc656d-245e-44ef-a375-65a2e63bac52","url":"https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-surgical-stapler-issue-intuitive-surgical","label":"U.S. FDA","publishedAt":"2026-03-01T00:00:00.000Z","notes":null,"title":null,"sourceName":"U.S. FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-18T22:25:08.999Z","updatedAt":"2026-07-18T22:25:08.999Z"},{"id":"3fcb315b-f84c-4350-a469-efd5e096ba68","incidentId":"ebbc656d-245e-44ef-a375-65a2e63bac52","url":"https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death","label":"FierceBiotech","publishedAt":"2026-03-20T00:00:00.000Z","notes":null,"title":null,"sourceName":"FierceBiotech","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-18T22:25:08.999Z","updatedAt":"2026-07-18T22:25:08.999Z"}],"responses":[],"statusEvents":[{"id":"bf4ba2fd-3d12-4314-8115-645fbe6613df","incidentId":"ebbc656d-245e-44ef-a375-65a2e63bac52","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-18T22:25:10.115Z","createdAt":"2026-07-18T22:25:10.115Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/intuitive-surgical-davinci-sureform-stapler-recall-2026-03","url":"https://registry.deploy.report/incidents/intuitive-surgical-davinci-sureform-stapler-recall-2026-03","headline":"Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death","description":"In March 2026, Intuitive Surgical recalled the gray reload cartridges for its da Vinci 8 mm SureForm 30 curved-tip stapler after incomplete staple line formation on blood vessels caused dangerous bleeding. As of late February 2026, the company reported four serious injuries and one patient death. Intuitive notified surgeons on March 11 to stop using gray reloads and switch to alternatives; the FDA amplified the issue through its early-alert program.","identifier":"ebbc656d-245e-44ef-a375-65a2e63bac52","datePublished":"2026-03-11T00:00:00.000Z","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":2,"primary_source_types":["primary-fda-database"]}}}