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
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 184 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 31 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 30 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 10 |
| MWS | Stabilizer, Heart | 8 |
| DWS | Instruments, Surgical, Cardiovascular | 5 |
| DXC | Clamp, Vascular | 4 |
| CAC | Apparatus, Autotransfusion | 2 |
| GBX | Catheter, Irrigation | 2 |
| DSP | System, Balloon, Intra-Aortic And Control | 1 |
| DSZ | Pacemaker Battery | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| FQH | Lavage, Jet | 1 |
| FZT | Cutter, Surgical | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| OFA | Cardiovascular Surgical Instruments Tray | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2026 | K252445 | Fusion Bioline Vascular Graft Maquet Cardiovascular, LLC | DSY |
| May 30, 2025 | K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Maquet Cardiovascular, LLC | GEI |
| Feb 26, 2025 | K243918 | Vasoview Hemopro 3 Power Supply Maquet Cardiovascular, LLC | GEI |
| Feb 27, 2024 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Maquet Cardiovascular, LLC | GEI |
| Apr 15, 2020 | K191930 | 7 mm Extended Length Endoscope Maquet Cardiovascular, LLC | GCJ |
| Sep 17, 2019 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Re Maquet Cardiovascular, LLC | GEI |
| Apr 19, 2016 | K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System Maquet Cardiovascular, LLC | GEI |
| Feb 16, 2016 | K153523 | FUSION Vascular Graft Maquet Cardiovascular, LLC | DSY |
| Dec 3, 2013 | K132743 | HARVESTING CANNULA Maquet Cardiovascular, LLC | GEI |
| Nov 14, 2013 | K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT Maquet Cardiovascular, LLC | DSY |
| Sep 10, 2012 | K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX Maquet Cardiovascular, LLC | MAL |
| Jun 11, 2010 | K101274 | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM Maquet Cardiovascular, LLC | GEI |
| Aug 28, 2009 | K091733 | VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 Maquet Cardiovascular, LLC | GEI |
| Dec 17, 2008 | K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE Maquet Cardiovascular, LLC | GBX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2026 | Maquet 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 |
GEI | K101274 |
| Sep 25, 2025 | Maquet 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 |
GEI | K251238 |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. Open, Classified |
DXC | K130382 |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. Open, Classified |
DXC | K130382 |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Open, Classified |
DXC | K130382 |
| Apr 18, 2025 | Maquet 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 |
GEI | K101274 |
| Apr 16, 2025 | Maquet 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 |
GEI | K101274 |
| Jan 3, 2025 | Maquet 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 |
GEI | K101274 |
| Jan 3, 2025 | Maquet 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 |
GEI | K101274 |
| Nov 18, 2024 | Maquet Cardiovascular, LLC Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z Open, Classified |
MWS | None listed |
| Nov 18, 2024 | Maquet Cardiovascular, LLC Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z Open, Classified |
MWS | None listed |
| Nov 18, 2024 | Maquet Cardiovascular, LLC Acrobat-i Positioner. Model Number C-XP-5000Z Open, Classified |
MWS | None listed |
| Oct 25, 2024 | Maquet Cardiovascular, LLC VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 Open, Classified |
GEI | K052274 K153194 |
| Jul 11, 2024 | Maquet 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 |
GEI | K101274 |
| Jul 11, 2024 | Maquet 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 |
GEI | K153194 |
| Jun 24, 2024 | Maquet 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 |
GEI | K153194 |
| Jun 24, 2024 | Maquet 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 |
GEI | K101274 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Open, Classified |
GEI | K153194 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . Open, Classified |
GEI | K052274 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Open, Classified |
CAC | K201305 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Open, Classified |
CAC | K043140 |
| Dec 19, 2023 | Maquet Cardiovascular, LLC Acrobat-i Vacuum Positioner System, Model Number XP-5000Z Open, Classified |
MWS | None listed |
| Nov 2, 2023 | Maquet 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 |
GEI | K091733 |
| Oct 22, 2023 | Maquet 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 |
MWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W Open, Classified |
GEI | K153194 |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 Open, Classified |
GEI | K101274 |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 Open, Classified |
GEI | K153194 |
| Mar 10, 2023 | Maquet Cardiovascular, LLC Fusion Bioline Vascular Graft, Part number M00201503046B0 Open, Classified |
DSY | K131778 |
| Jan 19, 2023 | Maquet Cardiovascular, LLC Vasoshield Syringe Packs, Model VH-5001 Open, Classified |
GBX | K082725 |
| Jan 19, 2023 | Maquet Cardiovascular, LLC Hemopro 2 with Vasoshield, Model VH-4001 Open, Classified |
GEI | K101274 |
| Apr 29, 2022 | Maquet 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 |
DSY | K984294 |
| Feb 9, 2022 | Maquet Cardiovascular, LLC Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. Open, Classified |
DWS | None listed |
| Jan 14, 2022 | Maquet 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 |
MAL | K954848 |
| Dec 1, 2021 | Maquet Cardiovascular, LLC Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 Terminated |
MAL | K954848 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
| Apr 7, 2020 | Maquet 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 |
MAL | None listed |
| Apr 7, 2020 | Maquet 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 |
MAL | K021213 |
Newest 50 of 271.