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This audio is auto-generated. Please let us know if you have feedback<\/a>.<\/p>\n Dive Brief:<\/p>\n Johnson & Johnson has started a Class I recall in response to the cybersecurity vulnerabilities of its automated Impella heart pump controllers. Dive Insight:<\/p>\n The FDA called the cybersecurity vulnerabilities an \u201cunacceptable residual risk related to network and physical access.\u201d If exploited, the vulnerabilities could result in \u201cuncontrolled risks\u201d affecting the device operating system, the agency said, and may affect the essential performance of the controllers. Abiomed used the same wording<\/a> in its letter to customers.<\/p>\n J&J\u2019s heart pump unit and the FDA both said the vulnerabilities \u201cmay potentially result in loss of device control or unexpected pump stop.\u201d The problems could result in life-threatening injury, permanent impairment or death. While no patients have been harmed, the FDA categorized Abiomed\u2019s action as a Class I recall because of the potential for serious injury or death.<\/p>\n Abiomed found the vulnerabilities\u00a0through internal routine cybersecurity risk assessments. All the vulnerabilities affect the operating system within the controller and do not extend beyond the console itself. Abiomed has not identified any risks to hospital networks.<\/p>\n The findings led the J&J unit to tell customers to keep the affected controllers in a secure environment with restricted access whether in clinical use or not. Field representatives for Abiomed are contacting customers to arrange to disable the devices\u2019 network capabilities. Customers can disable the capabilities themselves if they contact J&J for instructions.\u00a0<\/p>\n Abiomed said it is working on security updates and measures to fix the cybersecurity vulnerabilities. The company plans to provide more information when it is ready to deploy its fixes and reconnect devices to the network.<\/p>\n The recall affects the same five products as the early alert that the FDA published<\/a> last month. The early alert covered potentially fatal purge pressure issues linked to five serious injuries. FDA officials published early alerts about other issues with the controllers in July<\/a> and August<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"Listen to the article 2 min This audio is auto-generated. Please let us know if you have feedback.…\n","protected":false},"author":2,"featured_media":213742,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[49,48,84,392],"class_list":{"0":"post-213741","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-ca","9":"tag-canada","10":"tag-health","11":"tag-healthcare"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/213741","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=213741"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/213741\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/213742"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=213741"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=213741"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=213741"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nThe Food and Drug Administration published a notice<\/a> about the recall on Friday, nine days after J&J\u2019s Abiomed unit told customers about a problem that could result in life-threatening injuries.\u00a0
\nNo cyberattacks or harm to patients have been reported. The devices are staying on the market, with Abiomed working to disable the controllers\u2019 network capabilities to mitigate the risks.\u00a0 <\/p>\n