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.

Riverpoint Medical, LLC - Polypropylene Surgical Sutures - Class 2 Recall
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts

NOVADAQ TECHNOLOGIES INC. - SK6000 PAQ drape pouch - Class 2 Recall
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - STAPLER 30,IS4000 - Class 2 Recall
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2016 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - CURVEDTIP STAPLER 30,IS4000 - Class 2 Recall
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2016 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - STAPLER,IS4000 - Class 2 Recall
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Cardiovascular Surgery-the Heart Valve Division - COREVALVE EVOLUT R SYSTEM - Class 2 Recall
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2016 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - STAPLER 30, IS4000, model number 470430 - Class 2 Recall
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2016 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - STAPLER 45, IS4000, model number 470298 - Class 2 Recall
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2016 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - CURVEDTIP STAPLER 30,IS4000, model number 470530 - Class 2 Recall
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2016 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - HX2 Temperature Management Systems - Class 2 Recall
HX2" Temperature Management Systems; 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 conne...
Source: Medical Device Recalls - July 15, 2016 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - The Sarns Dual CoolerHeater - Class 2 Recall
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product Usage: The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery....
Source: Medical Device Recalls - July 15, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System (VCLAS) - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology. (Sou...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - MAQUET Extension Device - Class 2 Recall
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2016 Category: Medical Equipment Source Type: alerts

Sorin Group USA, Inc. - CDl H/S Cuvette Perfusion Pack or Smart Perfusion Pack - Class 3 Recall
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2016 Category: Medical Equipment Source Type: alerts

Medtronic - Covidien - Class 2 Recall
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be...
Source: Medical Device Recalls - February 19, 2016 Category: Medical Equipment Source Type: alerts