Class I medical device recall Archives - Public Safety & Vigilance

Medfusion 3500 and 4000 Syringe Pumps: Class I Medical Device Recall by US-FDA

Aug 26, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, Medfusion 3500 and 4000 Syringe Pumps, USFDA Medical Device Recall

On 24-Aug-2020, US-FDA has released a recall alert for class I medical Device- Medfusion 3500 and 4000 Syringe Pumps due to risk of medication delivery error. Device Use: This is used in the delivery of following products into the patient’s body in a controlled manner. Blood Blood products Prescribed medications Other fluids Syringe pumps which…

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…

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…

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…

Medical Device Class I Recall: Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters

May 17, 2020Public Safety & VigilanceMedical Device, Medical Device Recall, Medical Device UpdatesCatheters, Class I medical device recall, Embolectomy, Most serious type of medical device recall

On 12-May-2020, United States Food and Drug Administration (USFDA) released a recall news of medical devices (Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters) which are falling under class I category. This type of recall is most serious type of recall, as they may cause serious injuries or death. The Python Embolectomy…

Medical Device Class I recall: Langston® Dual Lumen Catheters

May 2, 2020Public Safety & VigilanceMedical Device, Medical Device Recall, Medical Device UpdatesClass I medical Device, Class I medical device recall, Dual Lumen Catheters, Langston, Most serious type of medical device recall

United States FDA announced that Vascular Solutions, Inc. is recalling Langston Dual Lumen Catheter, (a class I medical device) due to risk of separation during use During angiographic studies (Medical imaging tests), this Langston Dual Lumen Catheter is utilized for the rapid delivery of contrast agents (dye materials) into the patient blood vessels. This will…

Recall of a Class I Medical Device: A most serious type recall

Apr 7, 2020Public Safety & VigilanceMedical Device, Medical Device Recall, Medical Device UpdatesClass I medical Device, Class I medical device recall, LeMaitre Over the Wire Embolectomy Catheter, Medical Device Recall, Most serious type of medical device recall, USFDA alerts

The announcement of recall and withdrawal of medicinal products and medical devices of class II and class III from market is considered usual. The recall scenario of a class I medical device due to serious injury to patient’s health is very rare and requires quite attention. Class I medical devices are “considered safe” which does not…

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