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.

Olympus Corporation of the Americas - Olympus LTFS19010 - Class 2 Recall
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 6, 2024 Category: Medical Devices Source Type: alerts

Olympus Corporation of the Americas - Endoeye Flex Deflectable Videoscope Olympus LTFS1905 - Class 2 Recall
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 6, 2024 Category: Medical Devices Source Type: alerts

Olympus Corporation of the Americas - Thunderbeat - Class 2 Recall
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 13, 2023 Category: Medical Devices Source Type: alerts

Olympus Corporation of the Americas - Thunderbeat - Class 2 Recall
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 13, 2023 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular, LLC - ACROBAT SUV - Class 2 Recall
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2023 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular, LLC - ACROBAT V - Class 2 Recall
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2023 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular, LLC - ACCESSRAIL Platform - Class 2 Recall
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2023 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular, LLC - ACROBATi - Class 2 Recall
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2023 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. D...
Source: Medical Device Recalls - February 7, 2023 Category: Medical Devices Source Type: alerts

Ethicon, Inc. - Ethicon PDS II (polydioxanone) Suture - Class 2 Recall
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 15, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Philips Azurion 7 M20 - Class 2 Recall
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts

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