Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute h...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Perfusion Systems - MEDIVATORS HEMOCOR HPH700, HPH1400TS, HPH1000TS - Class 2 Recall
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Perfusion Systems - MEDTRONIC PERFUSION TUBING PACKS - Class 2 Recall
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the patient's hematocrit and fluid status. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2015 Category: Medical Equipment Source Type: alerts

Medtronic Perfusion Systems - Medtronic EOPA Arterial Cannula - Class 2 Recall
Medtronic EOPA¿ Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2015 Category: Medical Equipment Source Type: alerts

Sorin Group USA, Inc. - STOCKERT HEATERCOOLER SYSTEM 3T - Class 2 Recall
Sorin Stockert Heater-Cooler 3T, 120 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, 208 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, 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