Heartware, Inc. - HeartWare HVAD System Battery Charger AC Adapter - Class 1 Recall
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 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
Musculoskeletal Transplant Foundation, Inc. - QuickGraft - Class 2 Recall
QuickGraft¿ Model # 430PST (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2019 Category: Medical Devices Source Type: alerts
Heartware, Inc. - Ventricular Assist Device System Battery Charger - Class 2 Recall
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. Th...
Source: Medical Device Recalls - December 8, 2018 Category: Medical Devices Source Type: alerts
Heartware, Inc. - Heart Ware(TM) HVAD(TM) System - Class 2 Recall
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
Preservation Solutions, Inc. - Belzer UW & Waters IGL Cold Storage Solution - Class 2 Recall
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2018 Category: Medical Devices Source Type: alerts
Heartware - HeartWare Ventricular Assist System - Class 1 Recall
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2017 Category: Medical Equipment Source Type: alerts
Microgenics Corporation - QMS Everolimus Assay - Class 2 Recall
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant p...
Source: Medical Device Recalls - October 4, 2016 Category: Medical Equipment Source Type: alerts
Hospira Inc. - LifeCare PCA Plus II - Class 2 Recall
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 9, 2016 Category: Medical Equipment Source Type: alerts
HeartWare Inc - Ventricular Assist Device - Class 1 Recall
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 9, 2016 Category: Medical Equipment Source Type: alerts
Musculoskeletal Transplant Foundation, Inc. - Class 2 Recall
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2016 Category: Medical Equipment Source Type: alerts
St ӧ ckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 1, 2016 Category: American Health Source Type: alerts
St ӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 1, 2016 Category: American Health Source Type: alerts
Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 1, 2016 Category: American Health Source Type: alerts
Zimmer Biomet, Inc. - ZIMMER PATELLOFEMORAL JOINT PROSTHESIS - Class 2 Recall
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only." (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts
