Manufacturer

Maquet Cardiovascular, LLC

252 recalls in our database name Maquet Cardiovascular, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 252
Critical: 0
Severe: 30
Most recent: 2026-07-22

Of the 252 recalls from Maquet Cardiovascular, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (12%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 252

HighFDA (Devices)·Z-2741-2026·2026-07-22
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
Maquet Cardiovascular is recalling Vasoview Hemopro 2 devices from Lot 3000547797 due to exposure to out-of-specification sterilization during gamma sterilization. The affected devices may not be properly sterilized.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2636-2025·2025-10-01
Vessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
Vasoview Hemopro 3 Endoscopic Vessel Harvesting Systems are recalled after out-of-box failures including deformed jaw attachments, jaws not fully closed and lifted heater wire. 98 units are affected.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2587-2025·2025-09-24
Heartstring III 3.8 mm seal systems recalled over three identified failure modes
Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.
Product
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2586-2025·2025-09-24
Heartstring III seal systems recalled over failures to load, deploy and seal
Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.
Product
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2588-2025·2025-09-24
Heartstring III 4.3 mm seal systems recalled over loading and deployment failures
Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.
Product
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1622-2025·2025-04-30
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break
Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.
Product
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 cauterizin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1577-2025·2025-04-23
Maquet VH-3010 Power Supply Recalled for Inadequate Heating Function
Maquet Cardiovascular is recalling 110 units of the VH-3010 Power Supply due to an incorrect resistor that may prevent the HemoPro 2 harvesting tool jaws from heating adequately.
Product
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0711-2025·2025-01-15
VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall
FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.
Product
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0712-2025·2025-01-15
Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0485-2025·2024-11-27
Acrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall
Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.
Product
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0484-2025·2024-11-27
Maquet Cardiovascular Recalls Acrobat-i Positioners Due to Sterility Concerns
Maquet Cardiovascular is recalling 14,338 Acrobat-i Positioners because manufacturing deviations compromised the sterile barrier, meaning sterility cannot be assured during the product's 2-year shelf life.
Product
Acrobat-i Positioner. Model Number C-XP-5000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2025·2024-11-27
Acrobat-i Vacuum Stabilizer System Recalled for Sterile Barrier Compromise
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Product
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0092-2025·2024-11-06
VasoView HemoPro Vessel Harvesting System Recalled for Silicone Component Detachment
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
Product
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2024·2024-07-17
Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening
Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.
Product
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 cauterizin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2024·2024-07-17
Endoscopic Vessel Harvesting System Recalled for Altered Component Spacing
Maquet Cardiovascular is recalling 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to reports of C-Ring wire straightening and altered spacing between components. No adverse events have been reported.
Product
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, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2024·2024-07-03
VASOVIEW HemoPro harvesting system fluid ingress may disable cautery
Maquet Cardiovascular recalls VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems due to fluid ingress into the harvesting tool handle, which may prevent necessary cautery or cause unintended cautery during surgical procedures.
Product
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, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2024·2024-07-03
Endoscopic Vessel Harvesting System Recalled Due to Potential Cautery Malfunction
Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.
Product
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 VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0710-2024·2024-01-24
FDA Recalls Express Chest Drain Blood Recovery Units Over Infection Risk
Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.
Product
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0709-2024·2024-01-24
Express Chest Drains Recalled for Infection Risk from Recalled Syringes
Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.
Product
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2024·2024-01-24
Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk
Maquet Cardiovascular is recalling 38,094 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500, due to polyimide particulate matter contamination that may be introduced into the arterial conduit during coronary artery bypass or peripheral bypass surgery.
Product
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0723-2024·2024-01-24
Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk
Maquet Cardiovascular is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System (model VH-3000-W) because polyimide particulate matter may be present on the device and could be introduced into arterial conduits during bypass graft surgery.
Product
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0589-2024·2023-12-27
Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0210-2024·2023-11-08
Endoscopic Vessel Harvesting System Recalled for Incorrect Outer Box Packaging
Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.
Product
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).
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0137-2024·2023-11-01
Maquet Acrobat-i Cardiac Stabilizer Jaw May Break During Surgery
The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.
Product
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2023·2023-08-09
ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems
A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.
Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide