332 results
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Sources: EU EUDAMED, US FDA
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VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·December 17, 2009
VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·December 17, 2009
VASOVIEW 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·December 17, 2009
Acrobat-i Positioner. Model Number C-XP-5000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·March 26, 2010
EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·March 26, 2010
Vasoshield Syringe Packs, Model VH-5001
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GBX·December 22, 2022
Hemopro 2 with Vasoshield, Model VH-4001
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·December 22, 2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·February 9, 2022
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·October 30, 2013
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·May 31, 2024
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·May 31, 2024
Hemashield Gold Woven and Knitted Double Vascular Grafts.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010
Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·December 7, 2010
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020