Cardiovascular & Thoracic Surgery Alerts This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Ethicon Endo-Surgery Inc - Class 2 Recall
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2021 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo HX2 Temperature Management System - Class 2 Recall
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for ...
Source: Medical Device Recalls - June 5, 2021 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. Product Number: SIGTRSB60AMT (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2021 Category: Medical Devices Source Type: alerts

Stryker Sustainability Solutions - HARMONIC ACE7, Shears with Advanced Hemostasis - Class 2 Recall
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2021 Category: Medical Devices Source Type: alerts

Philips Ultrasound Inc - Philips EPIQ Diagnostic Ultrasound System - Class 2 Recall
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2021 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - Capiox FX25 Advance Oxygenator - Class 2 Recall
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - SYNMESH - Class 3 Recall
SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - SYNMESH - Class 3 Recall
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - STANDARD RING - Class 3 Recall
STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - SYNMESH - Class 3 Recall
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - END RING - Class 3 Recall
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - STANDARD RING - Class 3 Recall
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - END RING - Class 3 Recall
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - LOCKING SCREW LOW PROFILE - Class 3 Recall
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - END RING - Class 3 Recall
END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts