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.

26–50 of 252

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
HighFDA (Devices)·Z-2273-2023·2023-08-09
ACROBAT V Cardiac Stabilization System may fail to secure during surgery
A latch defect in the ACROBAT V Vacuum Off-Pump System may prevent proper heart stabilization during cardiac surgery. Maquet Cardiovascular recalled 594 units distributed worldwide.
Product
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2272-2023·2023-08-09
Cardiac Surgery Device Blade May Fail to Latch Securely During Use
The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.
Product
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2023·2023-04-12
Endoscopic vessel harvesting system recalled for sterilization defect
900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.
Product
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1336-2023·2023-04-12
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure
Maquet Cardiovascular is recalling approximately 2,300 units of the VASOVIEW HEMOPRO 2 system because some batches were not sterilized to specification. This sterilization failure creates a risk of contamination and potential infection during surgical procedures.
Product
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2023·2023-04-12
FDA Recalls VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System for Sterilization Failure
Maquet Cardiovascular is recalling VASOVIEW HEMOPRO endoscopic vessel harvesting systems because some batches were not sterilized to the required specifications.
Product
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2023·2023-03-22
Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect
Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.
Product
Fusion Bioline Vascular Graft, Part number M00201503046B0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2023·2023-01-25
Vasoshield Syringe Ink Chips May Cause Embolic Events
Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.
Product
Hemopro 2 with Vasoshield, Model VH-4001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2023·2023-01-25
Vasoshield Syringe Packs Recalled Due to Chipping Ink Risk
Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.
Product
Vasoshield Syringe Packs, Model VH-5001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2022·2022-06-29
INTERGARD Woven Vascular Graft mislabeled with incorrect size specification
Maquet Cardiovascular recalls INTERGARD Woven Vascular Grafts with incorrect labeling. Units labeled as 8 mm diameter instead contained 32 mm diameter grafts.
Product
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 bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic gr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0887-2022·2022-04-13
Surgical drive mechanism recalled due to corrosion risk
Maquet Cardiovascular is recalling the Ultima Activator II Reusable Drive Mechanism due to potential corrosion on pins, which could cause allergic reactions, metal toxicity, and other delayed health effects.
Product
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0729-2022·2022-03-16
Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications
A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.
Product
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 Code/REF Number: M002020952070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0403-2022·2021-12-29
Hemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall
Maquet Cardiovascular is recalling Hemashield Gold vascular grafts due to probable mislabeling. A different graft product may have been packaged in the carton.
Product
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1865-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1863-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk
Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Product
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 disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
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 disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.
Product
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
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 disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
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 disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1880-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
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 disease.
Category
Medical Device
Distribution
Distributed nationwide