Edwards Lifesciences Recall Information EZ Glide Cannulae
Edwards Lifesciences is initiating a voluntary product recall related to our EZ Glide aortic cannulae. The recall affects models EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA.
Edwards is taking this action after receiving three (3) reports that an EZ Glide cannula separated from its connector, causing a breach of the cardiopulmonary bypass (CPB) circuit and loss of blood. In each case, the description suggests that the separation occurred without any significant force being applied to the joint. Although the occurrence rate is very low (0.0034%), and all of the patients had successful surgical outcomes, in the interest of patient safety and transparency, Edwards is notifying customers of the events and requesting return of EZ Glide devices. Figure 1 shows the EZ Glide device and the location of the connector, cannula and where the two components are bonded together.
Manufacturing of the EZ Glide cannula was transferred from Edwards’ Draper, Utah, facility to a contract manufacturer in July 2018, and all three events involve devices made by the contract manufacturer. We have stopped all shipment of EZ Glide devices made by the contractor and ceased further production until the root cause is fully understood and additional controls are in place. This matter has been reported to FDA and other regulatory agencies.
Cannulae like the EZ Glide device are intended to perfuse the ascending aorta during cardiopulmonary bypass. These devices are life sustaining and open-heart surgeries cannot be performed without them. Since the flow in these cannulae is very high, a separation of this type could result in significant blood loss.
Edwards supplies more than 150,000 EZ Glide devices globally every year. Comparable aortic cannulae are manufactured by Edwards and by other companies. Details are being provided to customers on these possible alternatives. We will be working to address and resolve this matter as soon as possible in order to minimize impact on patient procedures. However, patient safety is our highest priority, and we are committed to a thorough analysis and resolution prior to resuming distribution of the product.
We are instructing EZ Glide customers to return all devices; however, we understand some customers may elect to use product from current inventory. In these situations, we believe it is possible for surgeons to identify devices with inadequate bonds prior to use. For those customers that keep the current inventory of product, Edwards is providing possible mitigations and recommends maintaining visibility of the device throughout the procedure.
Clinical or procedural questions may be directed to Thomas Morrissey, M.D., Vice President, Product Safety, at (949) 250-2042.
For all other questions, please call Edwards Customer Service Monday through Friday at (800) 424-3278, Option 1, from 8:00 AM – 4:00 PM Pacific Time.