Recall Z-0287-2027 ยท NPU Prosthesis, Mitral Valve, Percutaneously Delivered
Edwards Lifesciences, LLC
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
| Date | Nov 2, 2026 (initiated Oct 5, 2026) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue which may result in cardiovascular balloon rupturing. |
| Root 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 su |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.