{"id":"032b2113-bcc3-42c7-b9cf-aec3752ad679","slug":"wandercraft-atalante-x-lateral-balance-fall-recall-2025","kind":"recall","headline":"Wandercraft recalls Atalante X self-balancing exoskeleton over a lateral-balance issue that can cause patient falls","summary":"Wandercraft initiated a recall of its Atalante X hands-free self-balancing exoskeleton over a lateral-balance condition that could lead to a patient fall during use. Source: FDA device recall Z-1739-2025, accessdata.fda.gov (recall code PHL).","occurredAt":"2025-04-03T00:00:00.000Z","reviewStatus":"reviewed","modelId":"e09e4e3e-bb57-42b8-abb9-ecee81463743","deploymentId":"cc760012-47a7-4697-9f3d-6e9c801e0919","companyId":"1942437f-dbb8-4059-9dcb-6b87817b7950","dataCenterId":null,"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,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T09:38:44.956Z","updatedAt":"2026-08-09T05:24:01.599Z","model":{"id":"e09e4e3e-bb57-42b8-abb9-ecee81463743","companyId":"1942437f-dbb8-4059-9dcb-6b87817b7950","modelName":"Wandercraft Atalante X","slug":"wandercraft-atalante-x","description":"Powered, self-balancing full-body lower-limb exoskeleton that walks HANDS-FREE (no crutches) using AI-driven dynamic balance across ~12 actuated degrees of freedom. The autonomy is real-time balance/gait control; clinician sets the session. FDA cleared early 2024, indications expanded 2025 (MS, C4-L5 SCI). Deployed in 100+ rehab/research facilities.","formFactor":"exoskeleton","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"use":"medical rehab","control":"AI-driven autonomous dynamic balance (hands-free, no crutches)","powered":"yes (12 actuated DOF)","regulatory":"FDA cleared 2024, expanded 2025","body_region":"full-body lower-limb","availability":"commercial (100+ facilities)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.massdevice.com/fda-expands-indications-wandercraft-atalante-exoskeleton/","title":"Wandercraft Atalante X","sourceName":"MassDevice"},{"url":"https://en.wikipedia.org/wiki/Wandercraft","title":"Wandercraft","sourceName":"Wikipedia"},{"url":"https://en.wandercraft.eu/atalante","title":"Atalante X","sourceName":"Wandercraft"},{"url":"https://en.wandercraft.eu/atalante-x-rehabilitation-exoskeleton","title":"Atalante X rehabilitation exoskeleton","sourceName":"Wandercraft"}],"aliases":["Atalante X","Atalante"],"collisionRisk":"low","reviewNote":"reverified 2026-06-09 (Kimi-incident remediation): cited primary source resolves and matches manufacturer/reputable domain; relevance adjudicated.","manufacturerTermForTeleop":null,"keyFacts":[{"label":"Robot","value":"Atalante is a self-balancing, hands-free walking exoskeleton that requires no crutches."},{"label":"Technology","value":"Uses AI-driven dynamic balance for walking."},{"label":"Company type","value":"French powered-exoskeleton maker"},{"label":"Self-balancing rehabilitation exoskeleton (primary Wandercraft)","value":"Wandercraft describes Atalante X as a self-balancing, hands-free robotic exoskeleton for neurological rehabilitation ([Atalante X](https://en.wandercraft.eu/atalante))","sourceUrl":"https://en.wandercraft.eu/atalante"},{"label":"Clinical walking assistance (primary Wandercraft)","value":"Wandercraft says Atalante X uses powered joints and articulated ankles to support walking rehabilitation for people with gait impairments ([Atalante X rehabilitation exoskeleton](https://en.wandercraft.eu/atalante-x-rehabilitation-exoskeleton))","sourceUrl":"https://en.wandercraft.eu/atalante-x-rehabilitation-exoskeleton"}],"createdAt":"2026-06-06T01:25:40.922Z","updatedAt":"2026-09-29T19:52:20.766Z","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":"cc760012-47a7-4697-9f3d-6e9c801e0919","modelId":"e09e4e3e-bb57-42b8-abb9-ecee81463743","versionId":null,"locationId":"d76af03b-968b-433e-a038-7797665a6d6b","operatorId":"1942437f-dbb8-4059-9dcb-6b87817b7950","ownerId":null,"slug":"wandercraft-atalante-x-france-hospital","status":"operational","firstSeen":"2024-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["autonomous_operation"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":false,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"medium_11_100","siteEnvironment":"indoor","operatorType":"maker_operated","sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://wandercraft.eu/","title":"Wandercraft","date_accessed":"2026-06-07"},{"url":"https://www.therobotreport.com/first-patient-enrolls-clinical-trial-wandercraft-atalante-x-exoskeleton/","title":"First Patient Enrolls in Clinical Trial for Wandercraft Atalante X Exoskeleton","retrievedAt":"2026-06-27T12:00:00Z"}],"notes":"Wandercraft Atalante X self-balancing exoskeleton deployed at rehabilitation hospitals in Paris, France. Clinical trials and patient walking sessions.","keyFacts":[{"label":"Fleet","value":"Wandercraft Atalante X self-balancing exoskeleton"},{"label":"Coverage","value":"Rehabilitation hospitals in Paris, France"},{"label":"Use Case","value":"Clinical trials and patient walking sessions"},{"label":"Technology","value":"Self-balancing exoskeleton"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"commercial_10_99","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-06-07T22:54:27.167Z","updatedAt":"2026-08-21T14:23:32.007Z"},"company":{"id":"1942437f-dbb8-4059-9dcb-6b87817b7950","name":"Wandercraft","slug":"wandercraft","description":"Wandercraft is a French robotics maker (founded 2012, Paris) that builds self-balancing walking machines. Its original line is medical: the Atalante X rehabilitation [exoskeleton](/companies/exoskeleton-technologies), FDA cleared in 2024 and deployed in 100+ rehab and research facilities, and Eve, the personal-use version cleared by the FDA in August 2026. In 2025 the company applied the same dynamic-balance control stack to industry and built [Calvin-40](/models/wandercraft-calvin-40), a headless industrial humanoid, co-developed with [Renault Group](/companies/renault-group), which took a minority stake in June 2025 and is the first commercial customer.","status":"private","founded":2012,"hq":"Paris, France","hqLat":48.8534951,"hqLng":2.3483915,"hqGeocodedAt":"2026-08-05T14:54:34.836Z","hqAddress":null,"hqPrecision":null,"website":"wandercraft.eu","fundingTotal":"120000000","type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":77,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.massdevice.com/fda-expands-indications-wandercraft-atalante-exoskeleton/","title":"Wandercraft","sourceName":"MassDevice"},{"url":"https://en.wikipedia.org/wiki/Wandercraft","title":"Wandercraft","sourceName":"Wikipedia"},{"url":"https://www.wandercraft.eu/calvin","label":"Calvin-40","title":"Calvin-40","mediaType":"article","sourceName":"Wandercraft"},{"url":"https://www.globenewswire.com/news-release/2025/06/11/3097632/0/en/Wandercraft-announces-Series-D-Round-bringing-75M-in-total-funding-secured-for-global-acceleration-of-AI-powered-robotics.html","label":"Wandercraft announces Series D Round, bringing $75M in total funding secured","title":"Wandercraft announces Series D Round, bringing $75M in total funding secured","mediaType":"article","sourceName":"GlobeNewswire"}],"keyFacts":[{"label":"Two product lines","value":"Medical exoskeletons (Atalante X, Eve) and an industrial humanoid (Calvin-40)."},{"label":"Shared technology","value":"Both lines run the same self-balancing dynamic-gait control stack, developed over 12 years of exoskeleton work."},{"label":"Calvin-40 anchor customer","value":"Renault Group: one trial unit at the Douai plant, with a stated roadmap of about 10 robots by end 2026 and 350 across French and Spanish plants by end 2027."},{"label":"Company type","value":"French self-balancing robotics maker, Paris"}],"aliases":["Wandercraft SAS","Wandercraft S.A.S."],"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":"2026-06-06T01:25:37.962Z","updatedAt":"2026-09-15T04:18:09.500Z"},"derived":{"status":"active"},"sources":[{"id":"24f9c8b8-27eb-474f-a2a4-5efca0708276","incidentId":"032b2113-bcc3-42c7-b9cf-aec3752ad679","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Wandercraft&postdatefrom=01/01/2024&postdateto=12/31/2026","label":null,"publishedAt":null,"notes":null,"title":"FDA Recalls — Wandercraft","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:56:28.079Z","updatedAt":"2026-07-22T01:56:28.079Z"},{"id":"9d2c7d99-e7d0-42e3-bbd6-37171ce28000","incidentId":"032b2113-bcc3-42c7-b9cf-aec3752ad679","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=213308","label":null,"publishedAt":null,"notes":null,"title":"Class 2 Device Recall Atalante X","sourceName":"U.S. Food and Drug Administration","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-09-29T20:15:10.832Z","updatedAt":"2026-09-29T20:15:10.832Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/wandercraft-atalante-x-lateral-balance-fall-recall-2025","url":"https://registry.deploy.report/incidents/wandercraft-atalante-x-lateral-balance-fall-recall-2025","headline":"Wandercraft recalls Atalante X self-balancing exoskeleton over a lateral-balance issue that can cause patient falls","description":"Wandercraft initiated a recall of its Atalante X hands-free self-balancing exoskeleton over a lateral-balance condition that could lead to a patient fall during use. Source: FDA device recall Z-1739-2025, accessdata.fda.gov (recall code PHL).","identifier":"032b2113-bcc3-42c7-b9cf-aec3752ad679","datePublished":"2025-04-03T00:00:00.000Z","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"]}}}