Maquet Cardiovascular, LLC

Reports per year

Source: FDA adverse event reports by year received, 2008–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Electrosurgical, Cutting & Coagulation & AccessoriesGEI3,989
• Clamp, VascularDXC2,420
• Laparoscope, General & Plastic SurgeryGCJ244
• Unit, Cautery, Thermal, Ac-PoweredHQO149
• Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY92
• Stabilizer, HeartMWS87
• Graft, Vascular, Synthetic/Biologic CompositeMAL81
• Instruments, Surgical, CardiovascularDWS60
• Patch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneDXZ11
• System, Balloon, Intra-Aortic And ControlDSP8

Recent recalls

• 2026-07-15Open, ClassifiedUnder Investigation by firm

  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.

  Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.

• 2025-09-25Open, ClassifiedUnder Investigation by firm

  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. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.

  Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.

• 2025-09-18Open, ClassifiedUnder Investigation by firm

  Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

  Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

• 2025-09-18Open, ClassifiedUnder Investigation by firm

  Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

  Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

• 2025-09-18Open, ClassifiedUnder Investigation by firm

  Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.

  Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

• 2025-04-18Open, ClassifiedUnder Investigation by firm

  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 cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable.

  There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.

• 2025-04-16Open, ClassifiedUnder Investigation by firm

  Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

  Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.

• 2025-01-03Open, ClassifiedDevice Design

  VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

  Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

• 2025-01-03Open, ClassifiedDevice Design

  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.

  Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

• 2024-11-18Open, ClassifiedProcess change control

  Acrobat-i Positioner. Model Number C-XP-5000Z

  Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.