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.

Covidien LLC - Polysorb Braided Absorbable Suture - Class 2 Recall
Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2020 Category: Medical Devices Source Type: alerts

Covidien LLC - Polysorb Braided Absorbable Suture - Class 2 Recall
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2020 Category: Medical Devices Source Type: alerts

Covidien LLC - Polysorb Braided Absorbable Suture - Class 2 Recall
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2020 Category: Medical Devices Source Type: alerts

Covidien LLC - Polysorb Braided Absorbable Suture - Class 2 Recall
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2020 Category: Medical Devices Source Type: alerts

Teleflex Medical - SHERIDAN Endobronchial Tube - Class 2 Recall
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 19, 2019 Category: Medical Devices Source Type: alerts

Philips Ultrasound Inc - Philips EPIQ and Affiniti Ultrasound Systems - Class 2 Recall
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperat...
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts

Philips North America, LLC - Class 2 Recall
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating 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, interventi...
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts

Medline Industries Inc (Northpoint Services) - Antifog solution - Class 2 Recall
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPA...
Source: Medical Device Recalls - July 19, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular, LLC - Class 2 Recall
Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular, LLC - Class 2 Recall
Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2019 Category: Medical Devices Source Type: alerts

Ethicon, Inc. - Class 2 Recall
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2019 Category: Medical Devices Source Type: alerts

Covidien, PLC - Covidien Force TriVerse electrosurgical device - Class 2 Recall
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - QUADROXi Neonatal oxygenator - Class 1 Recall
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2018 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Quadroxi Neonatal Oxygenator - Class 1 Recall
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2018 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - VirtuoSaph Plus Endoscopic Vessel Harvesting System - Class 2 Recall
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requit¿ing blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or...
Source: Medical Device Recalls - October 25, 2018 Category: Medical Devices Source Type: alerts