US-FDA Archives - Page 2 of 2 - Public Safety & Vigilance

Class I Medical Device Recall: BodyGuard Infusion Pump System

Aug 8, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, US-FDA, USFDA-United States of AmericaBodyGuard Infusion Pump System, Class I medical device recall, Most serious type of medical device recall, USFDA Medical Device Recall

On 05-Aug-2020, US-FDA has released a recall alert for class I medical Device- BodyGuard Infusion Pump System due to the risk of over-fusion and under-infusion. Class I Medical Device Recall: As per the classification system by US-FDA, this device falls under the category of Class I medical device. This is the most serious type of…

USFDA Drug Safety Communication: Naloxone use for opioid use disorder

Jul 28, 2020Public Safety & VigilanceDrug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reportingNaloxone, Opioid overdose, Opioid use disorder, USFDA Drug Safety Communication

On 23-Jul-2020, United States Food and Drug Administration (USFDA) has released a recommendation for the use of Naloxone in the treatment of opioid use disorder and for patients who are at increased risk of opioid overdose. Opioids are a class of drugs which are used to reduce moderate to severe pain in patients who are…

Recall of Class I Medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”)

Jul 18, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, GlideScope Core One TouchSmart Cable, USFDA Medical Device Recall

On 17-Jul-2020, US-FDA released a recall alert for class I medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”) due to partial or complete loss of image during use. Device Use: The GlideScope Core Video Laryngoscopy System is intended to provide a clear view of the airway and vocal cords for medical procedures. The Core…

Recall of Class I Medical Device- Arrow AutoCAT®2 and AC3 Optimus® IABP Series

Jul 4, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaArrow AutoCAT®2 and AC3 Optimus® IABP Series, Class I medical device recall, USFDA Medical Device Recall

On 02-Jul-2020, US-FDA released a recall alert for class I medical Device– Arrow AutoCAT®2 and AC3 Optimus® IABP Series due to possible breakdown of motor connector wires. Device Use: The Arrow AutoCAT®2 and AC3 Optimus® are Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices which are used for patients who are undergoing cardiac and non-cardiac…

Recall of Class I Medical Device- Ovation iX Abdominal Stent Graft Systems

Jun 17, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaOvation iX Abdominal Stent Graft Systems, Recall of Class I medical Device, USFDA Medical Device Recall

On 16-Jun-2020, US-FDA released a recall alert for class I medical Device– Ovation iX Abdominal Stent Graft Systems due to the risks of polymer leaks during implantation Device Use: This device is used in endovascular treatment for patients with an abdominal aortic or aortoiliac aneurysms (AAA). Aortic Aneurysm is a condition which occurs when the aorta…

Class I Medical Device Recall: Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0

Jun 3, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, Most serious type of medical device recall, USFDA Medical Device Recall

On 01-Jun-2020, US-FDA has released a recall alert for class I medical Device– StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License Device Use: This device is used during a deep brain stimulation (DBS) procedure which provides images…

Medical Device Class I Recall-“HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief”

May 30, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, US-FDA, USFDA-United States of AmericaClass I medical device recall, HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief, Most serious type of medical device recall, USFDA Medical Device Recall

On 28-May-2020, US-FDA has released a recall alert for class I medical Device–HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Device Use: “HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief” are the parts of HeartWare Ventricular Assist Device (HVAD) System which help the heart in delivering blood to the rest of…

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.