Class 1 Device Recall Commander M Delivery System

• Date Initiated by Firm: October 05, 2026
• Date Posted: November 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0287-2027
• Recall Event ID: 100067
• PMA Number: P250019
• Product Classification: Prosthesis, mitral valve, percutaneously delivered - Product Code NPU
• Product: Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog Number: 9880CM29A Software Version: Not applicable. Product Description: Prosthesis, mitral valve, percutaneously delivered Component: No
• Code Information: Lot Code: Model No.: 9880CM29A; UDI-DI: 00690103219777; Recalled Lot Number(s): 67718561, 67804014, 67887043, 67887044.
• FEI Number: 2015691
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: Brian Hudson; +1-949-2503569
• Manufacturer Reason for Recall: Due to a manufacturing issue which may result in cardiovascular balloon rupturing.
• FDA Determined Cause: Process change control
• Action: On 10/05/2026, an "URGENT: MEDICAL DEVICE RECALL (PRODUCT REMOVAL)" Letter was sent via various delivery methods (e.g., electronic delivery (e-mail), FedEx Priority Overnight mail, or on-site visit) to customers informing them that, due to complaints certain manufacturing lots of the SAPIEN M3 Commander M delivery systems potentially contain a manufacturing defect, which may result in balloon burst during use. Customers are instructed to: " Review this notice carefully and share it with the appropriate clinical staff at their site. " Immediately examine their inventory and quarantine units subject to this recall. Do not use these affected units. Units with other lot numbers are not impacted by this recall and can continue to be used. " Complete the attached Customer Acknowledgment Form and return it to Edwards TMTT Representative or via email to US_FCA@edwards.com " Contact Customer Service at 1-800-424-3278 or email: CustomerServ_TMTT@edwards.com to obtain a Returned Goods Authorization (RGA) number and return any impacted product to Edwards. Edwards asks that customers complete the last two actions listed above within 15 days of receipt of this notification. Customers' assistance is crucial to ensuring this recall is executed thoroughly and promptly. This notice has been communicated by Edwards to the appropriate Regulatory Authorities. For questions and further assistance, contact an Edwards representative who can assist with product return.
• Quantity in Commerce: 164
• Distribution: U.S.: AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA and WA. O.U.S.: N/A
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NPU