Recall Register

Maquet Cardiovascular, LLC: FDA recalls

FDA enforcement reports name Maquet Cardiovascular, LLC as the recalling firm in 32 events. The events have 252 product records. The recalls started from 2012 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

32 events, newest first.

FDA enforcement events of Maquet Cardiovascular, LLC
InitiatedProduct (first record)TypeClassRecordsStatus
2 Jun 2026The 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.DeviceClass II1Ongoing
15 Aug 2025Heartstring III Proximal Seal System. Intravascular anastomosis occluder.DeviceClass II3Ongoing
6 Aug 2025Vasoview 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…DeviceClass II1Ongoing
20 Mar 2025The 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…DeviceClass II1Ongoing
10 Mar 2025Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).DeviceClass II1Ongoing
9 Dec 2024VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.DeviceClass I2Ongoing
16 Oct 2024Acrobat-i Positioner. Model Number C-XP-5000ZDeviceClass II3Ongoing
20 Sep 2024VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500DeviceClass I1Ongoing
31 May 2024The 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, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool…DeviceClass II2Ongoing
17 May 2024The 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 VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended…DeviceClass II2Ongoing
13 Dec 2023Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single CollectionDeviceClass I2Ongoing
1 Dec 2023Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .DeviceClass II2Ongoing
31 Oct 2023Acrobat-i Vacuum Positioner System, Model Number XP-5000ZDeviceClass II1Ongoing
19 Sep 2023Vasoview 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).DeviceClass II1Ongoing
13 Sep 2023Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000ZDeviceClass II1Ongoing
28 Jun 2023ACCESSRAIL 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.DeviceClass II4Ongoing
6 Mar 2023VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500DeviceClass II3Ongoing
30 Jan 2023Fusion Bioline Vascular Graft, Part number M00201503046B0DeviceClass II1Ongoing
22 Dec 2022Hemopro 2 with Vasoshield, Model VH-4001DeviceClass II2Ongoing
29 Apr 2022INTERGARD 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 bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations…DeviceClass II1Terminated
9 Feb 2022Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.DeviceClass II1Ongoing
14 Jan 2022HEMASHIELD 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 Code/REF Number: M002020952070DeviceClass II1Terminated
1 Dec 2021Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890DeviceClass II1Terminated
7 Apr 2020Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.DeviceClass II24Terminated
18 Apr 2019Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087DeviceClass II183Terminated
24 Jan 2019AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibilityDeviceClass II1Terminated
27 Jan 2017VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.DeviceClass II1Terminated
13 Aug 2014Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy…DeviceClass II1Terminated
30 Oct 2013Vasoview 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…DeviceClass II1Terminated
20 Sep 2013Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct…DeviceClass II1Terminated
7 Mar 2013MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring…DeviceClass II1Terminated
27 Mar 2012CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Maquet Cardiovascular, LLC: events for each product type
TypeEvents
Device32
Maquet Cardiovascular, LLC: events in each class
ClassEvents
Class II29
Class I3
Share of the events of the firm in Class I
9%
Share of all events on the register in Class I
18%
Events with the status Ongoing
20

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Maquet Cardiovascular, LLC, by the year that the recall started. The largest year is 2023, with 8 events.

Official channels

Cite this page

Recall Register. Maquet Cardiovascular, LLC: FDA recalls. https://recallregister.com/firm/maquet-cardiovascular-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Maquet Cardiovascular, LLC have?
Class II: 29 events. Class I: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Maquet Cardiovascular, LLC?
FDA event 99259, which the firm started on 2 Jun 2026. The first product in the record is: 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.
How many FDA recalls of Maquet Cardiovascular, LLC have the status Ongoing?
20 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.