Class I Medical Device Recall: Medfusion 3500 and 4000 Syringe Pumps

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

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

Class I Medical Device Recall: BodyGuard Infusion Pump System

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”)

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

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

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

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

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

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 from the US-FDA

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

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"

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

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

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

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: IMAGER II 5F Angiographic Catheters

A serious type of recall for medical device class I has announced by FDA for the Boston Scientific Corporation IMAGER II 5F Angiographic Catheters. This class I device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries during angiography. During the patient procedure preparation, potential for the catheter

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