Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks.
Here are some of the latest recalls reported to the FDA:
1. Baxter recalls mobile lift component over fall hazard
Baxter Healthcare recalled its Q-link 13 mobile lift component, which may allow for improper attachment of the quick-release hook on sling bars and other accessories. The issue could result in detachment and patient falls, posing a risk of serious injury or death. Healthcare providers and home patients were advised to stop using the affected Q-link 13 components and wait for replacement versions. Baxter has reported three serious injuries and one death.
2. Edwards LifeSciences recalls arterial cannula due to exposed wire
Edward LifeSciences recalled several arterial cannula products after identifying wire exposure at the cannula tip, which could lead to tissue damage, bleeding, inadequate perfusion and hemolysis. Products affected include the OptiSite arterial perfusion cannula and peripheral femoral arterial cannula. Customers were advised to remove the affected inventory and coordinate returns through the Edwards representatives. No injuries or deaths have been reported.
3. Ethicon issues correction for vascular stapler reload due to lockout risk
Ethicon Endo-Surgery issued a correction for its Endopath Echelon Vascular White Reload due potential inadvertent lockout during surgical procedures. The device may activate but fail to cut or staple tissue, requiring additional steps to safely remove it. Customers were advised to review the updated instructions and training resources. One death and one injury have been reported.
