Medtronic Perfusion Systems - Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir With Balance Biosurface - Class 1 Recall
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2020 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2020 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2020 Category: Medical Devices Source Type: alerts

KCI USA, INC. - Negative Pressure Wound Therapy Powered Suction Pump - Class 2 Recall
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2020 Category: Medical Devices Source Type: alerts

LABORIE MEDICAL TECHNOLOGIES, CANADA ULC - Pump Tube Set for MMS Libra and Solar Systems - Class 2 Recall
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2020 Category: Medical Devices Source Type: alerts

Medtronic Perfusion Systems - Medical Tubing with Cortiva BioActive Surface. - Class 2 Recall
Extra corporeal circuit with bio-active surface. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 5, 2020 Category: Medical Devices Source Type: alerts

Organ Recovery Systems, Inc. - LKT200 Perfusion Circuit for Lifeport Kidney Perfusion Transporter - Class 2 Recall
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc. - Smart Perfusion Pack - Class 3 Recall
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts