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.

Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts

Ethicon Endo-Surgery Inc - HARMONIC ACE Shears Adaptive Tissue Technology - Class 2 Recall
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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) and other open and endoscopic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts

Ethicon Endo-Surgery Inc - The HARMONIC ACE Shears Adaptive Tissue Technology - Class 2 Recall
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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) and other open and endoscopic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo HX2 Temperature Management System, Catalog No. 809810 - Class 2 Recall
Terumo¿ HX2" Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts

Tornier, Inc - Phantom Fiber Biofiber Sutures - Class 2 Recall
Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122...
Source: Medical Device Recalls - April 14, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Signia Power Handle - Class 2 Recall
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - staple, implantable - Class 2 Recall
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2018 Category: Medical Devices Source Type: alerts

Integra LifeSciences Corp. - Footswitch accessory - Class 2 Recall
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery i...
Source: Medical Device Recalls - February 24, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Roticulator - Class 2 Recall
Endo GIA" Auto Suture" Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2018 Category: Medical Devices Source Type: alerts

Intuitive Surgical, Inc. - daVinci EndoWrist(R) Stapler 45 - Class 2 Recall
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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 the same staple line or tissue buttressing material (natural synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2018 Category: Medical Devices Source Type: alerts

Philips Electronics North America Corporation - Philips Allura Xper R9 and Azurion R1.1 - Class 2 Recall
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and ele...
Source: Medical Device Recalls - December 19, 2017 Category: Medical Devices Source Type: alerts

Intuitive Surgical, Inc. - da Vinci Xi Surgical System - Class 2 Recall
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical 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 - April 6, 2017 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical 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 - April 6, 2017 Category: Medical Equipment Source Type: alerts

Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Czech SRK General and Plastic Surgery: The Intuitive Surgical 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 - April 6, 2017 Category: Medical Equipment Source Type: alerts