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

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

New Medical Device Approval: iTind, a non-surgical device for treating Benign Prostatic Hyperplasia (BPH)

On 07-Apr-2020, Olympus announced the approval of its non-surgical medical device, iTind for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). FDA has provided a De Novo classification for this product and classified it under Class II medical device category. It is a temporarily placed urethral opening system for symptoms of benign prostatic hyperplasia.

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

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

error: Content is protected !!