Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corp - Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System - Class 2 Recall
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary ...
Source: Medical Device Recalls - July 9, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corp - ComboMap Intravascular Flow and Pressure System - Class 2 Recall
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimati...
Source: Medical Device Recalls - July 9, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corp - Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System - Class 2 Recall
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral an...
Source: Medical Device Recalls - July 9, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - DLP Femoral Arterial Cannula; DLP Femoral Cannula and Insertion Kit (w. Femoral Arterial Cannula) - Class 2 Recall
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component parts. The cannula body is marked for depth insertion. The components are designed to fit over each other to progressively dilate the vessel during insertion. The dilator allows a 0.1-cm (0.038-in) guidewire to pass through it ...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
MEDTRONIC PERFUSION SYSTEMS - Class 2 Recall
Medtronic Model 550 Bio-Console Extracorporeal Blood Pumping Console for the Bio-Console Extracorporeal Blood Pumping System (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - 100/120V AC, Advanced Perfusion System Platform (APS) - Class 2 Recall
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2015 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - 100/120V AC, Advanced Perfusion System Platform (APS) - Class 2 Recall
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2015 Category: Medical Equipment Source Type: alerts
Stryker Neurovascular - Gateway OTW 2.75mm x 9mm; - Class 2 Recall
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface. - Class 2 Recall
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corp - Terumo Custom Cardiovascular and Perfusion Procedure Kits - Class 2 Recall
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2014 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 1 Recall
Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR (POST- CIRUGIA) (1) OPEN HEART TRAY Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts
