{"id":"c6a40461-8632-444b-b03e-e61f5c91ceef","slug":"recall-2025-05-16-edwards-lifesciences","kind":"recall","headline":"FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure","summary":"Edwards Lifesciences issued a Field Corrective Action for OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula models after discovering that a 3-4mm section of wire from the wire-reinforcement coil at the cannula tip could become exposed, risking major tissue damage, arterial puncture, bleeding, and hemolysis. No serious injuries or deaths reported as of May 20, 2025. The FDA classified this as the most serious type of recall.","occurredAt":"2025-05-16T12:00:00.000Z","reviewStatus":"unreviewed","modelId":"11d93de0-ecbc-40c1-9cbf-78faec650556","deploymentId":null,"companyId":"311e9cc4-68db-4d74-b74c-33fd30682fc4","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":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-07-07T11:07:55.260Z","updatedAt":"2026-07-07T11:07:55.260Z","model":{"id":"11d93de0-ecbc-40c1-9cbf-78faec650556","companyId":"311e9cc4-68db-4d74-b74c-33fd30682fc4","modelName":"SAPIEN 3 Transcatheter Heart Valve","slug":"sapien-3-transcatheter-heart-valve","description":"The SAPIEN 3 is a transcatheter aortic heart valve system used for TAVR (transcatheter aortic valve replacement) to treat severe aortic stenosis without open-heart surgery. FDA-approved for low-risk patients since August 2019, and approved for asymptomatic patients in May 2025. Includes SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA variants.","formFactor":"surgical","maturityStage":"production","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://en.wikipedia.org/wiki/Edwards_Lifesciences","title":"Edwards Lifesciences - Wikipedia","sourceName":"Wikipedia"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"S&P 500 Component","value":"Yes"},{"label":"Key Product","value":"Cordella Pulmonary Artery Sensor (FDA-approved June 2024 for heart failure management)"},{"label":"Manufacturing","value":"Irvine CA, Draper UT, Costa Rica, Singapore, Limerick Ireland, Moncada Spain (under construction)"}],"createdAt":"2026-07-07T11:06:51.948Z","updatedAt":"2026-07-08T20:01:39.696Z","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":"311e9cc4-68db-4d74-b74c-33fd30682fc4","name":"Edwards Lifesciences","slug":"edwards-lifesciences","description":"Edwards Lifesciences is an American medical technology company headquartered in [Irvine, California](https://en.wikipedia.org/wiki/Irvine,_California), specializing in tissue heart valves and transcatheter technologies for structural heart disease. Founded by Miles Lowell Edwards in 1958, the company invented the first successful artificial heart valve (the Starr-Edwards valve) and pioneered transcatheter aortic valve replacement (TAVR) with its [SAPIEN 3](https://www.edwards.com) platform. The company is listed on the NYSE (EW) and is an S&P 500 component.","status":"active","founded":1958,"hq":"Irvine, California, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.edwards.com/","title":"Edwards","date_accessed":"2026-06-07"}],"keyFacts":[{"label":"CEO","value":"Bernard J. Zovighian"},{"label":"Previous CEO","value":"Michael Mussallem (2000-2023, founder-era leader who took company public)"},{"label":"Founder","value":"Miles Lowell Edwards (electrical engineer, invented first artificial heart valve)"},{"label":"NYSE Ticker","value":"EW"},{"label":"S&P 500 Component","value":"Yes"},{"label":"Key Product","value":"Cordella Pulmonary Artery Sensor (FDA-approved June 2024 for heart failure management)"},{"label":"Manufacturing","value":"Irvine CA, Draper UT, Costa Rica, Singapore, Limerick Ireland, Moncada Spain (under construction)"},{"label":"Parent Company History","value":"Acquired by Baxter International 1985, spun off in 2000 IPO"},{"label":"Revenue 2025","value":"US.07 billion"},{"label":"Employees","value":"16,000 (2025)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-06-08T04:27:19.214Z","updatedAt":"2026-07-07T11:08:16.358Z"},"derived":{"status":"active"},"sources":[{"id":"226cd046-71ae-48eb-8f9a-7a1feb0ff1e8","incidentId":"c6a40461-8632-444b-b03e-e61f5c91ceef","url":"https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/arterial-cannula-recall-edwards-lifesciences-removes-arterial-cannula-due-risk-wire-exposure","label":null,"publishedAt":null,"notes":null,"title":"Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-07T11:07:55.645Z","updatedAt":"2026-07-07T11:07:55.645Z"}],"responses":[],"statusEvents":[{"id":"86b8d080-46a1-43a1-86d5-13f2db2da3db","incidentId":"c6a40461-8632-444b-b03e-e61f5c91ceef","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-07T11:07:56.026Z","createdAt":"2026-07-07T11:07:56.027Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2025-05-16-edwards-lifesciences","url":"https://registry.deploy.report/incidents/recall-2025-05-16-edwards-lifesciences","headline":"FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure","description":"Edwards Lifesciences issued a Field Corrective Action for OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula models after discovering that a 3-4mm section of wire from the wire-reinforcement coil at the cannula tip could become exposed, risking major tissue damage, arterial puncture, bleeding, and hemolysis. No serious injuries or deaths reported as of May 20, 2025. The FDA classified this as the most serious type of recall.","identifier":"c6a40461-8632-444b-b03e-e61f5c91ceef","datePublished":"2025-05-16T12:00:00.000Z","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":1,"primary_source_types":["primary-fda-database"]}}}