Les autorit\u00e9s sanitaires am\u00e9ricaines ont signal\u00e9 un rappel de dispositifs m\u00e9dicaux concernant des sondes Infinion CX Lead, utilis\u00e9es dans les syst\u00e8mes de stimulation de la moelle \u00e9pini\u00e8re (Spinal Cord Stimulator, SCS) pour la prise en charge de la douleur chronique du dos ou des membres. La Food and Drug Administration (FDA) classe ce rappel dans la cat\u00e9gorie la plus grave, en raison d\u2019un risque de blessure grave ou de d\u00e9c\u00e8s en cas de poursuite de l\u2019utilisation des produits concern\u00e9s.<\/p>\n
Le fabricant Boston Scientific a inform\u00e9 ses clients le 17 juin 2026 de la n\u00e9cessit\u00e9 de retirer et de renvoyer tous les produits non utilis\u00e9s. Sont concern\u00e9s les kits de sondes Infinion CX Lead de 50 cm (mod\u00e8le SC-2317-50M365, GTIN 008714729861614) et de 70 cm (mod\u00e8le SC-2317-70M365, GTIN 008714729861638). Les dispositifs d\u00e9j\u00e0 implant\u00e9s ne sont pas inclus dans l\u2019action de rappel. Aucune surveillance suppl\u00e9mentaire des patients n\u2019est recommand\u00e9e au-del\u00e0 du suivi clinique habituel.<\/p>\n
Boston Scientific indique que le corps de la sonde du syst\u00e8me de stimulation m\u00e9dullaire peut subir des contraintes m\u00e9caniques au niveau du dispositif d\u2019ancrage, pouvant entra\u00eener des mesures d\u2019imp\u00e9dance anormales ou des fractures de la sonde. Ces dysfonctionnements peuvent conduire \u00e0 une stimulation inefficace et\/ou n\u00e9cessiter des interventions suppl\u00e9mentaires, notamment l\u2019explantation et le remplacement de la sonde. Au 27 mai 2026, 1 081 blessures graves et aucun d\u00e9c\u00e8s avaient \u00e9t\u00e9 signal\u00e9s \u00e0 Boston Scientific en lien avec ce probl\u00e8me.<\/p>\n
Les \u00e9tablissements de sant\u00e9 am\u00e9ricains ayant des stocks doivent cesser imm\u00e9diatement l\u2019utilisation et la distribution des produits vis\u00e9s, les isoler, les retourner au fabricant et diffuser l\u2019information \u00e0 tous les professionnels concern\u00e9s ainsi qu\u2019aux organisations auxquelles ces dispositifs auraient pu \u00eatre transf\u00e9r\u00e9s. Les patients et professionnels de sant\u00e9 aux \u00c9tats-Unis peuvent d\u00e9clarer tout incident ou probl\u00e8me de qualit\u00e9 via le syst\u00e8me MedWatch de la FDA.<\/p>\n
La FDA rappelle par ailleurs l\u2019importance du syst\u00e8me d\u2019identification unique des dispositifs m\u00e9dicaux (Unique Device Identifier, UDI), qui permet un tra\u00e7age am\u00e9lior\u00e9 des dispositifs, une meilleure d\u00e9claration et analyse des \u00e9v\u00e9nements ind\u00e9sirables, et un rep\u00e9rage plus rapide des produits concern\u00e9s par des incidents de s\u00e9curit\u00e9. Des ressources sp\u00e9cifiques de la FDA (base de donn\u00e9es de rappels de dispositifs m\u00e9dicaux, base AccessGUDID pour l\u2019identification des dispositifs) sont mobilis\u00e9es dans ce cadre. Les \u00e9l\u00e9ments pr\u00e9sent\u00e9s concernent le contexte am\u00e9ricain, sans indication d\u2019impact direct sur d\u2019autres pays. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Les autorit\u00e9s sanitaires am\u00e9ricaines ont signal\u00e9 un rappel de dispositifs m\u00e9dicaux concernant des sondes Infinion CX Lead, utilis\u00e9es dans les syst\u00e8mes de stimulation de la moelle \u00e9pini\u00e8re (Spinal Cord Stimulator, […]<\/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-17797","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\/17797","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=17797"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17797\/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=17797"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17797"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}