Class 2 Device Recall Edwards Lifesciencese Aortic Perfusion Cannulae

• Date Initiated by Firm: October 22, 2019
• Create Date: November 18, 2019
• Recall Status: Terminated on June 29, 2022
• Recall Number: Z-0420-2020
• Recall Event ID: 84065
• 510(K)Number: K123370
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): ; EZC21A (00690103174182), ; EZC21TA (00690103174199), ; EZC24A (00690103714401), ; EZC24TA (00690103714418),; EZF21A (00690103175080),; EZF21TA (00690103175097),; EZF24A (00690103175066), ; EZF24TA (00690103175073), ; EZS21A (00690103172096),; EZS21TA (00690103172102), ; EZS24A (00690103172119), ; and EZS24TA (00690103172126); Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.
• Code Information: Lot #s: 203876 207654 217024 226788,205724, 207655, 217025, 226938,205775, 208823, 217048, 227494,205868, 208893, 218185, 227886,205920, 208894, 218457, 228009,205921, 209901, 218539, 228259,205922, 209904, 219090, 228549,206369, 210110, 219212, 228558,206372, 210111, 219561, 229051,206373, 212032 ,220146 ,229054,206374, 212033 ,220151 ,229827,206768, 212034 ,220157 ,230690,206769, 212035 ,220802 ,230894,206770, 212258 ,220803 ,231105,206771, 212280 ,222841 ,231109,206772, 212959 ,222913 ,231111,206773, 213506 ,222914 ,231291,206774, 213914 ,222915 ,231485,206775, 214214 ,223174 ,232109,206776 ,214216 ,224233 ,232437,206777 ,214716 ,224235 ,234138,206778 ,214717 ,224662,207319 ,214961 ,224707,207320 ,215239 ,225306,207321 ,215495 ,225884,207322 ,216123 ,225885,207323 ,216196 ,226188,207324 ,216627 ,226596,207636 ,216628 ,226597,207638 ,216632, 226691
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: Customer Service; 1800-424-3278 Ext. 1
• Manufacturer Reason for Recall: Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm plans to begin mailing a "urgent - Product Recall" notification on 10/22/2019 via FedEx Next Day Delivery. All recall notification letters should be mailed by 10/23/2019. The customer notification will request consignees take the following actions: 1. Review this field safety notice to understand the potential hazard, and return all unused inventory as instructed. 2. Complete and return the Product Reconciliation Form to Customer Service: a) Record the quantity of any affected EZ Glide aortic perfusion cannula in your possession, b) Segregate and quarantine affected product until returned, c) Determine the quantity of EZ Glide aortic perfusion cannula used by subtracting the quantity on hand from the quantity shipped to you, d) Contact Customer Service to arrange return of affected devices, and e) Return affected devices to Edwards with the Return Goods Authorization (RGA) provided. 3. Complete and return the attached Acknowledgement Form within five (5) business days of receiving this notice to Customer Service via fax at (800) 422-9329 or email to cs.usfaxes@edwards.com. 4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. If you have further distributed this product, notify your customers to the user level. Report any EZ Glide separation to Edwards Lifesciences. 5. The firm reccomends using an alternative device. However if another device is not available the firm provides the following instructions: Should you elect to use the EZ Glide device in your inventory, we suggest grasping each side of the bond area and applying a firm pull before use to confirm the bond is secure. We also recommend maintaining visibility of the device throughout the procedure. Potential mitigations in the event of cannula separation include ensuring a backup device or 3/8 x 3/8 connector is available. 6. Edwards has communicated this Field Safety Notice to ap
• Quantity in Commerce: 62,431 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES, LLC.