Maquet Cardiovascular, LLC

FDA Regulatory Profile

Summary

Total Recalls
251 (5 Class I)
510(k) Clearances
13
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2587-2025Class IIHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.August 15, 2025
Z-2586-2025Class IIHeartstring III Proximal Seal System. Intravascular anastomosis occluder.August 15, 2025
Z-2588-2025Class IIHeartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.August 15, 2025
Z-2636-2025Class IIVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3August 6, 2025
Z-1622-2025Class IIThe VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with tMarch 20, 2025
Z-1577-2025Class IIMaquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVMarch 10, 2025
Z-0711-2025Class IVasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use iDecember 9, 2024
Z-0712-2025Class IVasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. IndiDecember 9, 2024
Z-0484-2025Class IIAcrobat-i Positioner. Model Number C-XP-5000ZOctober 16, 2024
Z-0486-2025Class IIAcrobat-i Vacuum Stabilizer System. Model Number C-OM-10000ZOctober 16, 2024
Z-0485-2025Class IIAcrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000ZOctober 16, 2024
Z-0092-2025Class IVasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500September 20, 2024
Z-2338-2024Class IIThe VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with tMay 31, 2024
Z-2337-2024Class IIThe VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with thMay 31, 2024
Z-2175-2024Class IIThe VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView HMay 17, 2024
Z-2176-2024Class IIThe VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with tMay 17, 2024
Z-0709-2024Class IProduct REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single CollectionDecember 13, 2023
Z-0710-2024Class IProduct REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery UnitDecember 13, 2023
Z-0724-2024Class IIVasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.December 1, 2023
Z-0723-2024Class IIVasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .December 1, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic VessMay 30, 2025
K243918Vasoview Hemopro 3 Power SupplyFebruary 26, 2025
K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic VessFebruary 27, 2024
K1919307 mm Extended Length EndoscopeApril 15, 2020
K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, FixedSeptember 17, 2019
K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemApril 19, 2016
K153523FUSION Vascular GraftFebruary 16, 2016
K132743HARVESTING CANNULADecember 3, 2013
K131778FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFTNovember 14, 2013
K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXXSeptember 10, 2012
K101274VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEMJune 11, 2010
K091733VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500August 28, 2009
K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEDecember 17, 2008