4 recalls found for Maquet Cardiovascular. Check if any of your products are affected.
Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to three identified failure modes. The device may fail to load, deploy, or provide adequate hemostasis during use. Healthcare providers must stop using the device immediately and contact the manufacturer for guidance.
Maquet Cardiovascular recalled 168 Heartstring III Proximal Seal System intravascular occluders worldwide, including the United States. Three failure modes have been identified: loading the Heartstring Seal, deploying it into the aortotomy, and achieving adequate hemostasis. Healthcare facilities should stop using the device and follow the manufacturer’s recall instructions.
Maquet Cardiovascular recalls the Heartstring III Proximal Seal System, a 3.8 mm intravascular anastomosis occluder used by hospitals worldwide. Three failure modes have been identified: loading failure, deployment failure, and failure to provide adequate hemostasis. Healthcare facilities should stop using the device immediately and follow manufacturer recall instructions.
Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.