Maquet Cardiovascular, LLC
31 federal recalls on file, showing the 4 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Maquet Cardiovascular, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-01FDA-DeviceClass IIVasoview 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.
- 2025-09-24FDA-DeviceClass IIHeartstring 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.
- 2025-09-24FDA-DeviceClass IIHeartstring 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.
- 2025-09-24FDA-DeviceClass IIHeartstring 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.
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