ClearanceBrief
Company ยท US

Maquet Cardiovascular, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.

14510(k) clearances (1 in 12 months)
271recalls (1 in 12 months)
254recalls that name a 510(k)

Product codes

CodeDeviceRecords
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass184
GEIElectrosurgical, Cutting & Coagulation & Accessories31
MALGraft, Vascular, Synthetic/Biologic Composite30
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter10
MWSStabilizer, Heart8
DWSInstruments, Surgical, Cardiovascular5
DXCClamp, Vascular4
CACApparatus, Autotransfusion2
GBXCatheter, Irrigation2
DSPSystem, Balloon, Intra-Aortic And Control1
DSZPacemaker Battery1
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass1
DWETubing, Pump, Cardiopulmonary Bypass1
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1
FQHLavage, Jet1
FZTCutter, Surgical1
GCJLaparoscope, General & Plastic Surgery1
OFACardiovascular Surgical Instruments Tray1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 27, 2026K252445Fusion Bioline Vascular Graft
Maquet Cardiovascular, LLC
DSY
May 30, 2025K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System
Maquet Cardiovascular, LLC
GEI
Feb 26, 2025K243918Vasoview Hemopro 3 Power Supply
Maquet Cardiovascular, LLC
GEI
Feb 27, 2024K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System
Maquet Cardiovascular, LLC
GEI
Apr 15, 2020K1919307 mm Extended Length Endoscope
Maquet Cardiovascular, LLC
GCJ
Sep 17, 2019K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Re
Maquet Cardiovascular, LLC
GEI
Apr 19, 2016K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting System
Maquet Cardiovascular, LLC
GEI
Feb 16, 2016K153523FUSION Vascular Graft
Maquet Cardiovascular, LLC
DSY
Dec 3, 2013K132743HARVESTING CANNULA
Maquet Cardiovascular, LLC
GEI
Nov 14, 2013K131778FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
Maquet Cardiovascular, LLC
DSY
Sep 10, 2012K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
Maquet Cardiovascular, LLC
MAL
Jun 11, 2010K101274VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
Maquet Cardiovascular, LLC
GEI
Aug 28, 2009K091733VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
Maquet Cardiovascular, LLC
GEI
Dec 17, 2008K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGE
Maquet Cardiovascular, LLC
GBX

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 15, 2026Maquet Cardiovascular, LLC
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K10127
Open, Classified
GEIK101274
Sep 25, 2025Maquet Cardiovascular, LLC
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting ki
Open, Classified
GEIK251238
Sep 18, 2025Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Open, Classified
DXCK130382
Sep 18, 2025Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Open, Classified
DXCK130382
Sep 18, 2025Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Open, Classified
DXCK130382
Apr 18, 2025Maquet Cardiovascular, LLC
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,
Open, Classified
GEIK101274
Apr 16, 2025Maquet Cardiovascular, LLC
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Open, Classified
GEIK101274
Jan 3, 2025Maquet Cardiovascular, LLC
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Open, Classified
GEIK101274
Jan 3, 2025Maquet Cardiovascular, LLC
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Open, Classified
GEIK101274
Nov 18, 2024Maquet Cardiovascular, LLC
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Open, Classified
MWSNone listed
Nov 18, 2024Maquet Cardiovascular, LLC
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Open, Classified
MWSNone listed
Nov 18, 2024Maquet Cardiovascular, LLC
Acrobat-i Positioner. Model Number C-XP-5000Z
Open, Classified
MWSNone listed
Oct 25, 2024Maquet Cardiovascular, LLC
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Open, Classified
GEIK052274
K153194
Jul 11, 2024Maquet Cardiovascular, LLC
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,
Open, Classified
GEIK101274
Jul 11, 2024Maquet Cardiovascular, LLC
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,
Open, Classified
GEIK153194
Jun 24, 2024Maquet Cardiovascular, LLC
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
Open, Classified
GEIK153194
Jun 24, 2024Maquet Cardiovascular, LLC
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The
Open, Classified
GEIK101274
Jan 12, 2024Maquet Cardiovascular, LLC
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Open, Classified
GEIK153194
Jan 12, 2024Maquet Cardiovascular, LLC
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Open, Classified
GEIK052274
Jan 12, 2024Maquet Cardiovascular, LLC
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Open, Classified
CACK201305
Jan 12, 2024Maquet Cardiovascular, LLC
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Open, Classified
CACK043140
Dec 19, 2023Maquet Cardiovascular, LLC
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Open, Classified
MWSNone listed
Nov 2, 2023Maquet Cardiovascular, LLC
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Open, Classified
GEIK091733
Oct 22, 2023Maquet Cardiovascular, LLC
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Open, Classified
MWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Apr 4, 2023Maquet Cardiovascular, LLC
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Open, Classified
GEIK153194
Apr 4, 2023Maquet Cardiovascular, LLC
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Open, Classified
GEIK101274
Apr 4, 2023Maquet Cardiovascular, LLC
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Open, Classified
GEIK153194
Mar 10, 2023Maquet Cardiovascular, LLC
Fusion Bioline Vascular Graft, Part number M00201503046B0
Open, Classified
DSYK131778
Jan 19, 2023Maquet Cardiovascular, LLC
Vasoshield Syringe Packs, Model VH-5001
Open, Classified
GBXK082725
Jan 19, 2023Maquet Cardiovascular, LLC
Hemopro 2 with Vasoshield, Model VH-4001
Open, Classified
GEIK101274
Apr 29, 2022Maquet Cardiovascular, LLC
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and b
Terminated
DSYK984294
Feb 9, 2022Maquet Cardiovascular, LLC
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Open, Classified
DWSNone listed
Jan 14, 2022Maquet Cardiovascular, LLC
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Cod
Terminated
MALK954848
Dec 1, 2021Maquet Cardiovascular, LLC
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Terminated
MALK954848
Apr 7, 2020Maquet Cardiovascular, LLC
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 di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
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 di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d
Terminated
MALK021213
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive d
Terminated
MALNone listed
Apr 7, 2020Maquet Cardiovascular, LLC
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive di
Terminated
MALK021213

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