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Sources: EU EUDAMED, US FDA
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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 Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·December 18, 2013
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
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
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
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
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - 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
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - 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
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - 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
Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019