Medtronic recalls thousands of cannulae due to risk of leaks
Medtronic is recalling specific lots of six different medical devices used as arterial cannulae during cardiopulmonary bypass procedures. This includes multiple models of the company’s 22FR EOPA 3D Arterial Cannulae and its 22FR EOPA Elongated One-Piece Arterial Cannulae.
Medtronic initiated the new recall after receiving more than 30 reports of small pinhole leaks in the wire-wound body of the devices. These leaks can be difficult to identify during routine inspection; they are primarily visible when the cannula is in a flexed position.
“Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia and organ dysfunction,” according to an alert shared with customers.
At this time, however, no adverse patient outcomes have been reported.
The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.”
Which medical devices are included in this recall?
In total, this Class II recall includes more than 50,000 medical devices that were distributed worldwide.
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77422 – 21, 290 units
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77522 – 11,720 units
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, Model Number 77622 – 13,510 units
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, Model Number 77722 – 3,110 units
- EOPA 3D Arterial Cannula DIL TIP 22FR, Model Number 78222 – 3,621 units
- EOPA 3D Arterial Cannula 22FR, Model Number 78322 – 1,424 units
The EOPA Elongated One-Piece Arterial Cannula from Medtronic. Image courtesy of Medtronic marketing materials.
What should customers do?
Customers have been advised to quarantine all unused devices and work toward returning them to Medtronic. No further actions are needed for patients who have already been treated with these devices.
“Please share this notification with others in your organization as appropriate,” Medtronic added.
Click here to for additional details from the FDA.
Another cannula recall for Medtronic
Medtronic has initiated multiple cannula recalls in recent months. In May, more than 18,000 devices were recalled due to a risk of contamination. Less than two months later, the company recalled certain lots of two different cannulae after trace amounts of blood were identified within their sealed packaging.
Just like this latest incident, these were both Class II recalls.
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.