Maquet Cardiovascular, LLC FDA Recalls

38 recalls on file across devices, 5 of them Class I and 35 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Related datasets

FDA ApprovalsNew drugs approved, and devices cleared for sale.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.

Product	Reason	Class	Initiated
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-useClass IIJun 2, 2026Getinge identified that Vasoview Hemopro 2 devices from Lot	Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification	Class IIDevices	Jun 2, 2026
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.Class IIAug 15, 2025Three failure modes have been identified: failure of the Hea	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring	Class IIDevices	Aug 15, 2025
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.Class IIAug 15, 2025Three failure modes have been identified: failure of the Hea	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring	Class IIDevices	Aug 15, 2025
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.Class IIAug 15, 2025Three failure modes have been identified: failure of the Hea	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring	Class IIDevices	Aug 15, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel HClass IIAug 6, 2025Reports of out-of-box failures discovered during the limited	Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled defor	Class IIDevices	Aug 6, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended lenClass IIMar 20, 2025There have been at least 12 complaints from users as of Marc	There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the cera	Class IIDevices	Mar 20, 2025
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)Class IIMar 10, 2025Incorrect resistor utilized in the VH-3010 Power Supply, whi	Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adeq	Class IIDevices	Mar 10, 2025
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasiveClass IDec 9, 2024Potential for two issues: 1. Bent or detached heater wire;	Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws o	Class IDevices	Dec 9, 2024
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minClass IDec 9, 2024Potential for two issues: 1. Bent or detached heater wire;	Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws o	Class IDevices	Dec 9, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000ZClass IIOct 16, 2024Deviations in the manufacturing process created a compromise	Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot	Class IIDevices	Oct 16, 2024
Acrobat-i Positioner. Model Number C-XP-5000ZClass IIOct 16, 2024Deviations in the manufacturing process created a compromise	Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot	Class IIDevices	Oct 16, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000ZClass IIOct 16, 2024Deviations in the manufacturing process created a compromise	Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot	Class IIDevices	Oct 16, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500Class ISep 20, 2024There were reports of the silicone detaching from the Jaws o	There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.	Class IDevices	Sep 20, 2024
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended LenClass IIMay 31, 2024There were 27 complaints between March 22, 2024, and April 3	There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting	Class IIDevices	May 31, 2024
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended LengClass IIMay 31, 2024There were 27 complaints between March 22, 2024, and April 3	There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting	Class IIDevices	May 31, 2024
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended LenClass IIMay 17, 2024Potential for there to be a fluid ingress into the handle of	Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device	Class IIDevices	May 17, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model NumbClass IIMay 17, 2024Potential for there to be a fluid ingress into the handle of	Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device	Class IIDevices	May 17, 2024
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single CollectionClass IDec 13, 2023Express chest drains are pre-packaged with sterile water syr	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is n	Class IDevices	Dec 13, 2023
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery UnitClass IDec 13, 2023Express chest drains are pre-packaged with sterile water syr	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is n	Class IDevices	Dec 13, 2023
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .Class IIDec 1, 2023Risk of polyimide particulate matter being present on the en	Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may	Class IIDevices	Dec 1, 2023
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.Class IIDec 1, 2023Risk of polyimide particulate matter being present on the en	Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may	Class IIDevices	Dec 1, 2023
Acrobat-i Vacuum Positioner System, Model Number XP-5000ZClass IIOct 31, 2023The Positioner Arm may not tighten or lock during normal use	The Positioner Arm may not tighten or lock during normal use.	Class IIDevices	Oct 31, 2023
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, oClass IISep 19, 2023Device packaged inside an incorrect outer box; displaying ar	Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.	Class IIDevices	Sep 19, 2023
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sClass IISep 13, 2023Housing Mount Jaw of these devices breaking during normal us	Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissu	Class IIDevices	Sep 13, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chesClass IIJun 28, 2023The Standard Blade may not securely latch onto the Activator	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabil	Class IIDevices	Jun 28, 2023
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chestClass IIJun 28, 2023The Standard Blade may not securely latch onto the Activator	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabil	Class IIDevices	Jun 28, 2023
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chClass IIJun 28, 2023The Standard Blade may not securely latch onto the Activator	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabil	Class IIDevices	Jun 28, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and cClass IIJun 28, 2023The Standard Blade may not securely latch onto the Activator	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabil	Class IIDevices	Jun 28, 2023
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-WClass IIMar 6, 2023Some batches of product were not sterilized to their minimum	Some batches of product were not sterilized to their minimum sterilization specification.	Class IIDevices	Mar 6, 2023
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000Class IIMar 6, 2023Some batches of product were not sterilized to their minimum	Some batches of product were not sterilized to their minimum sterilization specification.	Class IIDevices	Mar 6, 2023
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500Class IIMar 6, 2023Some batches of product were not sterilized to their minimum	Some batches of product were not sterilized to their minimum sterilization specification.	Class IIDevices	Mar 6, 2023
Fusion Bioline Vascular Graft, Part number M00201503046B0Class IIJan 30, 2023One (1) Fusion Bioline Vascular graft from lot 25162546, whi	One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was inte	Class IIDevices	Jan 30, 2023
Vasoshield Syringe Packs, Model VH-5001Class IIDec 22, 2022Ink on the Vasoshield syringe Maquet logo may chip resulting	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. P	Class IIDevices	Dec 22, 2022
Hemopro 2 with Vasoshield, Model VH-4001Class IIDec 22, 2022Ink on the Vasoshield syringe Maquet logo may chip resulting	Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. P	Class IIDevices	Dec 22, 2022
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surfaClass IIApr 29, 2022Mislabeled: Product labeled as Intergard Woven Straight gra	Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an	Class IIDevices	Apr 29, 2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.Class IIFeb 9, 2022Potential for corrosion on the pins of the Ultima Activator	Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include all	Class IIDevices	Feb 9, 2022
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement Class IIJan 14, 2022Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Vel	Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40	Class IIDevices	Jan 14, 2022
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890Class IIDec 1, 2021There is a probable mislabeling of product. A Hemashield Pl	There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Gra	Class IIDevices	Dec 1, 2021