Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats-Unis a \u00e9mis une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant certains contr\u00f4leurs automatis\u00e9s Impella (Automated Impella Controllers \u2013 AIC) fabriqu\u00e9s par la soci\u00e9t\u00e9 Abiomed. Cette alerte vise \u00e0 informer le public d\u2019un risque de s\u00e9curit\u00e9 li\u00e9 \u00e0 des dispositifs m\u00e9dicaux de soutien h\u00e9modynamique et sera actualis\u00e9e par la FDA au fur et \u00e0 mesure de la disponibilit\u00e9 de nouvelles informations significatives.<\/p>\n
Les dispositifs concern\u00e9s sont des consoles de contr\u00f4le Impella commercialis\u00e9es aux \u00c9tats-Unis sous diff\u00e9rentes r\u00e9f\u00e9rences : Impella Controller, Packaged, US (num\u00e9ro de produit 0042-0000-US ; UDI-DI 00813502010022, limit\u00e9 \u00e0 certains exemplaires), Impella Optical Controller, Packaged, US (0042-0010-US ; UDI-DI 00813502010985) et Optical, AIC, Impella Controller, Packaged US (0042-0040-US ; UDI-DI 00813502011401). Une liste sp\u00e9cifique de num\u00e9ros de s\u00e9rie impact\u00e9s a \u00e9t\u00e9 \u00e9tablie par Abiomed ; le num\u00e9ro de s\u00e9rie figure sur une \u00e9tiquette situ\u00e9e sur le c\u00f4t\u00e9 droit de chaque console.<\/p>\n
Abiomed a indiqu\u00e9, \u00e0 la suite d\u2019un examen r\u00e9trospectif de ses enregistrements de maintenance, que certains contr\u00f4leurs Impella n\u00e9cessitent des mises \u00e0 jour mat\u00e9rielles, logicielles et\/ou de micrologiciel pour corriger des d\u00e9fauts de qualit\u00e9 susceptibles d\u2019avoir des implications de s\u00e9curit\u00e9. Les probl\u00e8mes identifi\u00e9s incluent : une incapacit\u00e9 potentielle du contr\u00f4leur \u00e0 reconna\u00eetre la cassette de purge lors de l\u2019installation ou du changement, un bouton d\u00e9faillant ou peu fiable pouvant nuire \u00e0 la capacit\u00e9 de l\u2019op\u00e9rateur \u00e0 s\u00e9lectionner et confirmer les entr\u00e9es de menu et entra\u00eener une perte possible de contr\u00f4le de la console, une instabilit\u00e9 logicielle pouvant provoquer un \u00e9chec au d\u00e9marrage, ainsi que d\u2019autres d\u00e9fauts logiciels. En l\u2019absence de ces mises \u00e0 jour, les patients pourraient \u00eatre expos\u00e9s \u00e0 des retards de traitement, \u00e0 une efficacit\u00e9 h\u00e9modynamique insuffisante ou perdue, et \u00e0 d\u2019autres probl\u00e8mes graves. Au 8 septembre 2026, Abiomed a d\u00e9clar\u00e9 ne pas avoir recens\u00e9 de blessure grave ni de d\u00e9c\u00e8s li\u00e9s \u00e0 ces d\u00e9fauts.<\/p>\n
Le 18 septembre 2026, Abiomed a adress\u00e9 un courrier \u00e0 tous les clients concern\u00e9s avec plusieurs recommandations. Les \u00e9tablissements de sant\u00e9 sont autoris\u00e9s \u00e0 continuer d\u2019utiliser les dispositifs pr\u00e9sents dans leur inventaire, dans l\u2019attente de la prise en charge par le service Abiomed, afin d\u2019assurer la continuit\u00e9 des soins. L\u2019entreprise pr\u00e9voit de contacter les clients pour coordonner le retrait, la mise \u00e0 jour et le retour des consoles affect\u00e9es. Les \u00e9tablissements doivent diffuser l\u2019information \u00e0 toutes les personnes concern\u00e9es en interne (gestion, transport, stockage, approvisionnement, utilisation de ces produits) et, si des dispositifs ont \u00e9t\u00e9 transf\u00e9r\u00e9s \u00e0 un autre \u00e9tablissement, transmettre \u00e9galement l\u2019avis \u00e0 ce dernier. La FDA invite par ailleurs les utilisateurs \u00e0 consulter r\u00e9guli\u00e8rement la page d\u00e9di\u00e9e pour suivre les mises \u00e0 jour de cette alerte.<\/p>\n
Les autorit\u00e9s impliqu\u00e9es sont la FDA, via son centre CDRH, charg\u00e9e de la surveillance et de l\u2019information du public sur les dispositifs m\u00e9dicaux, et Abiomed, en tant que fabricant responsable de l\u2019identification des d\u00e9fauts de qualit\u00e9, de la notification aux clients et de la mise en \u0153uvre des mesures correctives. Les enjeux de politique publique portent principalement sur la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux implantables ou de soutien critique, la gestion des risques en \u00e9tablissement de sant\u00e9, la continuit\u00e9 des soins malgr\u00e9 des retraits ou mises \u00e0 jour de mat\u00e9riels, et la n\u00e9cessit\u00e9 d\u2019une coordination efficace entre autorit\u00e9s de r\u00e9gulation, fabricants et structures de soins en cas de d\u00e9tection de d\u00e9fauts susceptibles d\u2019affecter la s\u00e9curit\u00e9 des patients. Cette alerte am\u00e9ricaine peut pr\u00e9senter un int\u00e9r\u00eat de comparaison pour les autorit\u00e9s fran\u00e7aises charg\u00e9es de la surveillance des dispositifs m\u00e9dicaux et de l\u2019organisation de la s\u00e9curit\u00e9 des soins, notamment concernant les pratiques d\u2019alerte pr\u00e9coce, de communication aux \u00e9tablissements et de suivi des mesures correctives. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats-Unis a \u00e9mis une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-18576","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18576","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=18576"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18576\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18576"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18576"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18576"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}