Biosense Webster, Inc. - CARTO VIZIGO BiDirectional Guiding Sheath - Class 2 Recall
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, a...
Source: Medical Device Recalls - March 14, 2024 Category: Medical Devices Source Type: alerts
Micro Therapeutics, Inc. - Apollo Onyx Delivery Micro Catheter - Class 2 Recall
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vascu...
Source: Medical Device Recalls - March 5, 2024 Category: Medical Devices Source Type: alerts
Sage Products Inc - stryker Sage PrimaFit - Class 2 Recall
stryker Sage PrimaFit External Urine Management System for the Female Anatomy (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2023 Category: Medical Devices Source Type: alerts
Aizu Olympus Co., Ltd. - Class 2 Recall
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Models: LF-DP LF-GP LF-TP (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2023 Category: Medical Devices Source Type: alerts
Aizu Olympus Co., Ltd. - Class 2 Recall
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Models: LF-V (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2023 Category: Medical Devices Source Type: alerts
Aizu Olympus Co., Ltd. - Class 2 Recall
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Models: ENF-T3 ENF-VT2 ENF-VT3 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2023 Category: Medical Devices Source Type: alerts
Aizu Olympus Co., Ltd. - Class 2 Recall
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Models: MAF-DM2 MAF-GM MAF-GM2 MAF-TM MAF-TM2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2023 Category: Medical Devices Source Type: alerts
Exocad GmbH - Class 2 Recall
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2023 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc.-Littleton - O2 Imaging System - Class 2 Recall
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2023 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Olympus VISERA Tracheal Intubation - Class 2 Recall
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 5, 2023 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Flexiva Pulse 242 TracTip SingleUse Laser Fibers - Class 2 Recall
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Flexiva Pulse 242 TracTip SingleUse Laser Fibers - Class 2 Recall
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Flexiva Pulse ID - Class 2 Recall
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Flexiva Pulse ID 242 TracTip single Use Fiber - Class 2 Recall
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts
