Medtronic recalls surgical devices due to risk of blood contamination
Medtronic is recalling certain lots of two surgical devices, the Bio-Medicus Adult Cannula Kit and the DLP One-Piece Pediatric Arterial Cannula, after trace amounts of blood were identified within their sealed packaging. No patients were exposed to the foreign material, and no adverse events were reported, but Medtronic is still recalling the devices as a precaution.
The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall. This means using the devices could result in “temporary or medically reversible adverse health consequences.”
What these devices do
The Bio-Medicus Adult Cannula Kit and the DLP One-Piece Pediatric Arterial Cannula are used to perform cardiopulmonary bypass procedures prior to open heart surgery on adult and pediatric patients, respectively. This diverts the circulation of blood away from the heart and lungs during surgery, adds oxygen to the blood and then pumps it back into the patient’s body.
The Bio-Medicus Adult Cannula Kit. Image courtesy of Medtronic.
What customers should do
Medtronic sent customers an alert about this Class II recall on June 4 after receiving two complaints. The alert urged customers to inspect their inventory in personal protective equipment and then discard any devices included in the recall in a “clearly marked biohazard bag or container.”
“Potential risks from direct contact with the blood contamination may include embolism, neurological dysfunction thromboembolism, organ dysfunction, biological reaction, infection and sepsis,” according to Medtronic’s communication. “Based on the two events observed with blood contamination, the likelihood of these events occurring is considered rare or highly unlikely.”
No actions need to be taken for patients already treated with one of these devices.
Click here for additional information from the FDA.
Medtronic shares a statement
Medtronic confirmed the recall in a quick statement to Cardiovascular Business.
"There have been no reports of patient injury, harm or adverse clinical effects," a company representative said. "We are always guided by the Medtronic Mission, to strive without reserve for the greatest possible reliability and quality in our products. The safety and well-being of patients is our priority as we seek to fulfill our mission to alleviate pain, restore health and extend life for patients."
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.