FDA details multiple Class I recalls for Edwards Lifesciences surgical devices
Edwards Lifesciences has recalled more than 61,000 cannulae due to a potential safety risk, according to new details shared by the U.S. Food and Drug Administration (FDA). There are six recalls in total, and they cover the OptiSite Arterial Cannula and FEM-Flex II Femoral Arterial Cannula.
These devices are used by clinicians to perform cardiopulmonary bypass procedures and other cardiac surgeries. The safety concern behind the recalls involves a small section of wire, approximately 3 or 4 mm long, that could potentially become uncovered during treatment and cause serious tissue damage.
At this time, Edwards has received no reports of patient injuries. However, due to the risks associated with this issue, the FDA ruled that these are all Class I recalls. This means that, according to the agency, the use of these OptiSite and FEM-Flex II devices could result in “serious adverse health consequences or death.”
The OptiSite Arterial Perfusion cannula from Edwards Lifesciences.
Edwards Lifesciences shares a statement
“Edwards Lifesciences promptly identified and addressed an issue in a small number of OptiSite Arterial Perfusion cannulae, where a segment of wire from the tip became uncovered from the cannula body,” a company spokesperson told Cardiovascular Business. “This was identified during routine quality checks before any procedures took place, and customers were immediately notified. No injuries have occurred. As a precaution, related femoral arterial cannula models were also included in the notice.”
What should customers do?
The medical devices included in these recalls were sold and distributed all over the world.
In May, Edwards Lifesciences sent urgent warnings to its customers that detailed this potential risk. The company instructed customers to review their inventories and return any impacted devices.
No patient follow-up or notification is necessary, but all clinical staff should be made aware of these Class I recalls. Edwards Lifesciences is still reviewing the situation to determine what may have led to this safety concern.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.