{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "215625", "product_res_number": "Z-2586-2025", "event_date_initiated": "2025-08-15", "event_date_posted": "2025-09-18", "recall_status": "Open, Classified", "res_event_number": "97450", "product_code": "DXC", "k_numbers": [ "K130382" ], "product_description": "Heartstring III Proximal Seal System. \tIntravascular anastomosis occluder.", "code_info": "Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.", "firm_fei_number": "2242352", "recalling_firm": "Maquet Cardiovascular, LLC", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "reason_for_recall": "Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.", "root_cause_description": "Under Investigation by firm", "action": "Consignees were sent an URGENT MEDICAL DEVICE CORRECTION notification dated August 2025. The notification provides instructions for consignees to carry out in the instance of failure of the Heartstring Seal to load, failure of the Heartsring III Seal to deploy into the aortotomy, and failure of the deployed Heartstring III Seal to provide adequate hemostasis. Consignees are asked to forward the recall notification to individuals within their organization who use the recalled devices and to organizations to which product was further distributed. Consignees are to return the completed response form to recallresponses.qrc@getinge.com. Questions about this recall can be directed to Getinge Customer Service at 1-888-880-2874.\n\n****Update 4/17/2026****\nOn August 15, 2025 URGENT MEDICAL DEVICE CORRECTION lupdate letters were sent to customers providing updated instructions for consignees to carry out in the instance of failure of the Heartstring Seal to load, failure of the Heartsring III Seal to deploy into the aortotomy, and failure of the deployed Heartstring III Seal to provide adequate hemostasis. Consignees are asked to forward the recall notification to individuals within their organization who use the recalled devices and to organizations to which product was further distributed. Consignees are to return the completed response form to recallresponses.qrc@getinge.com. Questions about this recall can be directed to Getinge Customer Service at 1-888-880-2874.", "product_quantity": "126 units (91 US, 35 OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K935494", "K970638", "K032125", "K221661", "K132651", "K112662", "K032589", "K980128", "K190351", "K802244", "K901628", "K881158", "K002767", "K980002", "K011078", "K262086", "K980631", "K041486", "K813499", "K963716", "K133029", "K010117", "K033085", "K221843", "K163693", "K071225", "K981624", "K260105", "K962668", "K123551", "K024107", "K955270", "K040615", "K962366", "K203803", "K983471", "K102048", "K770503", "K910221", "K882879", "K130124", "K883696", "K031812", "K955742", "K170958", "K201695", "K222182", "K962510", "K070485", "K132293", "K984214", "K072834", "K040730", "K150813", "K110193", "K022880", "K111837", "K063871", "K935964", "K141685", "K132175", "K801395", "K021608", "K022754", "K992980", "K982365", "K010727", "K080206", "K011863", "K885161", "K011208", "K123077", "K920501", "K992174", "K070380", "K000098", "K970027", "K861924", "K964547", "K897075", "K113182", "K210324", "K925809", "K920936", "K192413", "K923085", "K012041", "K950492", "K053398", "K964161", "K070661", "K915280", "K123035", "K891296", "K161315", "K964663", "K230281", "K112694", "K123041", "K964662", "K123694", "K972689", "K955827", "K210681", "K981956", "K162027", "K131561", "K243627", "K213531", "K082930", "K102025", "K123571", "K112384", "K123194", "K974769", "K883790", "K980087", "K173563", "K062474", "K982182", "K894670", "K982278", "K051817", "K851739", "K010694", "K113600", "K973132", "K791098", "K962858", "K963503", "K991589", "K002915", "K010785", "K914149", "K992053", "K130482", "K895691", "K130382", "K070423", "K810162", "K153259", "K110148", "K252772", "K772137", "K151363", "K881447", "K072167", "K061075", "K230248", "K973216", "K254060", "K050146", "K961100", "K875090", "K190318", "K191827", "K951413", "K092503", "K852479", "K881448", "K944259", "K014277", "K023682", "K921399", "K062569", "K964251", "K813062", "K152525", "K203307", "K955132", "K092544", "K232577", "K761169", "K162988", "K992640", "K942812", "K080169", "K090286", "K832554", "K820949", "K122405", "K990573", "K831809", "K143078", "K072297", "K053300", "K070323", "K131411", "K061484", "K253070", "K210006", "K863427", "K142359", "K980898", "K973080", "K120492", "K142122", "K901565", "K954669", "K140805", "K970611", "K943948", "K961461", "K180723", "K023154" ], "registration_number": [ "3009810261", "", "1720929", "2219920", "3018312328", "9612086", "3008500478", "2518902", "1625519", "1721504", "3010601992", "1531062", "2183620", "1625425", "1721676", "3030078769", "3022815697", "3010383847", "3008864603", "2953359", "9616088", "3016733629", "2027111", "3004050854", "3010235355", "3027815", "3048101437", "2950160", "3032916632", "3005528784", "1423537", "3031282706", "3006015326", "1643116", "9615817", "3006082230", "8010422", "3023316", "3010707607", "1062741", "1225991", "1836161", "3008998256", "3010652124", "2320762", "8010697", "9680837", "1424263", "1016427", "2916714", "1416980", "1646747", "3019807891", "3005809810", "1927395", "3012179728", "3006542380", "1421879", "1054811", "3032534", "3001650535", "2183744", "2085887", "1118880", "3016096142", "2031768", "3017056829", "3010055973", "3016704581", "3033589330", "3018348", "1054241", "8010303", "3003761012", "3007740583", "1032347", "1424478", "1450019", "8010591", "3003675041", "3015151147", "9710524", "1724474", "8010026", "2528981", "1423662", "1522875", "3008258694", "3010687973", "9612074", "3004111573", "2648623", "3033536312", "1420032", "3015309643", "3031571797", "1055236", "3009605245", "3004102031", "3014342096", "3005593675", "3010141307", "2024024", "1043214", "3005034064", "9610617", "3009051888", "3015547863", "9610612", "8030107", "3008002401", "1720747", "1923569", "1643817", "2134812", "1417592", "3007361214", "1220477", "2242352", "1644312", "1018233", "3030454941", "3012050423", "2648612", "1450662", "3011564431", "1319660", "3007830707", "3010131137", "1225598", "3012507533", "8040233", "3008729892", "2015691", "1219659", "3003418325", "8010871", "1226015", "1421101", "3020031299", "2245304", "3015225571", "2011171", "3011642792", "3006947772", "2126670", "2032098", "1220351", "9680519", "9681834", "3004215117", "1060680", "9680515", "9616972", "3021140368", "2020550", "3006405073", "2246552", "3007648354", "8010168", "3010041511", "3007074233", "3005334138", "3004608878", "3008717566", "3009164961", "3006554912", "3011137372", "2648045", "8010372", "3009763019", "3006950086", "9611112", "3008770252", "9611484", "3038185753", "2030624", "3009142291", "3013849323", "3012536737", "3042940336", "1056350", "2029275", "9614747", "3012995405", "3010202439", "1061927", "3005687633" ], "fei_number": [ "3009810261", "3002539629", "3003499455", "", "1720929", "1000140363", "2219920", "3018312328", "1000117748", "2518902", "3002827704", "1625519", "3010601992", "3000215205", "3000203000", "2183620", "1721504", "1000115048", "1625425", "3002807072", "1721676", "3030078769", "2828", "3003944071", "3022815697", "3010383847", "3008864603", "3016733629", "1000306431", "3003058448", "7682", "2027111", "3004050854", "3010235355", "3002750084", "3006125446", "3048101437", "3032916632", "3005528784", "3031282706", "3006015326", "1643116", "3001236905", "3006082230", "3023316", "3010707607", "3004053982", "3010652124", "3008998256", "3003081151", "3008782585", "3000302153", "1016427", "2916714", "1416980", "3019807891", "3005809810", "1927395", "3012179728", "3006542380", "3002807390", "3001650535", "2183744", "1118880", "3016096142", "3005747797", "3017056829", "3010055973", "3016704581", "3033589330", "3001237365", "3002806575", "1000123971", "3018348", "3003761012", "3007740583", "1032347", "3002808327", "3002807555", "1450019", "3003675041", "3015151147", "3002902165", "2528981", "1000112968", "1000160162", "1522875", "3000215273", "3003094851", "3008258694", "3010687973", "3004111573", "2648623", "3033536312", "1000135614", "1420032", "3002806315", "3015309643", "3002768455", "3031571797", "3002808268", "4439", "3009605245", "3004102031", "3000206435", "3002631673", "1000208624", "3003249645", "3014342096", "3005593675", "3010141307", "2024024", "1043214", "3005034064", "3005969827", "3009051888", "3015547863", "1713910", "3008002401", "1000136478", "1720747", "3005649458", "3002690289", "1923569", "1643817", "1417592", "3007361214", "1220477", "3002565916", "2242352", "1018233", "3030454941", "3012050423", "1000453845", "3007475226", "3001738911", "6166", "2648612", "1450662", "1000114185", "3011564431", "1000127185", "3007830707", "3007290840", "3010131137", "3012507533", "3003015552", "2015691", "1219659", "3003418325", "3020031299", "1421101", "2245304", "3015225571", "2011171", "3011642792", "3006947772", "2126670", "1220351", "3004215117", "3021140368", "2020550", "3006405073", "3002516348", "2246552", "3007648354", "3010041511", "3007074233", "3005334138", "1000112877", "3004608878", "3008717566", "3009164961", "3008238512", "3006554912", "2648045", "3009763019", "3006950086", "3003040625", "3008770252", "3038185753", "3009142291", "3013849323", "3012536737", "3042940336", "3002902735", "3012995405", "3005687633" ], "device_name": "Clamp, Vascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4450", "device_class": "2" } } ] }