Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

On January 30, 2020, Medtronic released the first round of software updates to address some of the affected devices. Medtronic will issue additional rounds of software updates to address the remaining devices. These software updates will be installed on devices automatically. For more information, see Medtronic’s Security Bulletin. Date Issued March 21, 2019 Audience Patients…

2020 Medical Device Recalls

The list below contains recalls that were issued in 2020. 2020 Medical Device Recalls Content current as of: 01/29/2020 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/medical-device-recalls/2020-medical-device-recalls

Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication – FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

[Posted: January 28, 2020] AUDIENCE: Patient, Health Professional ISSUE: FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed and treated quickly. BACKGROUND: Clozapine affects how…

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

Summary Company Announcement Date: January 24, 2020 FDA Publish Date: January 24, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device exhibits a reversed image Company Name: King Systems Brand Name: Brand Name(s) King Vision Product Description: Product Description Laryngoscope Adapter Company Announcement On November 5, 2019, King Systems initiated a voluntary…

2020 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2020 Safety Communications Content current as of: 01/23/2020 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2020-safety-communications

Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication

Date Issued: January 23, 2020 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored. These devices are used mostly in health care facilities for displaying…

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

Summary Company Announcement Date: January 15, 2020 FDA Publish Date: January 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of Assurance of Sterility Company Name: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal Brand Name: Brand Name(s) AXIA Pharmaceutical Product Description: Product Description Sterile Drug Products Company Announcement FUSION IV Pharmaceuticals, Inc…

Surgical Gowns and Packs by Cardinal Health: FDA Statement – Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

[Posted 01/16/2020] AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.  FDA also understands this issue may already be impacting patient care at health care facilities, such as the cancellation of…

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result…