Maquet Cardiovascular, LLC
Maquet Cardiovascular, LLC holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 252 FDA device recalls on record.
Top product codes for Maquet Cardiovascular, LLC
FDA recalls by Maquet Cardiovascular, LLC
10 most recent of 252- Z-2741-2026 — 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 K101274.
- Z-2588-2025 — Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
- Z-2587-2025 — Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Z-2586-2025 — Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Z-2636-2025 — 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 kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.
- Z-1622-2025 — 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 the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable.
- Z-1577-2025 — Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
- Z-0712-2025 — 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.
- Z-0711-2025 — VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
- Z-0485-2025 — Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Maquet Cardiovascular, LLC
- K252445 — Fusion Bioline Vascular Graft
- K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) +2 more
- K243918 — Vasoview Hemopro 3 Power Supply
- K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
- K191930 — 7 mm Extended Length Endoscope
- K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
- K153194 — VASOVIEW HemoPro Endoscopic Vessel Harvesting System
- K153523 — FUSION Vascular Graft
- K132743 — HARVESTING CANNULA
- K131778 — FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
- K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
- K101274 — VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K091733 — VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
- K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.