Device recall
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
- Recall number
- Z-0287-2027
- Event id
- 100067
- Status
- Open, Classified
- FDA classification
- Class III
- Recalling firm
- Edwards Lifesciences, LLC
- Posted
- Nov 2, 2026
- Initiated
- Oct 5, 2026
- Product code
- NPU
- Device type
- Prosthesis, Mitral Valve, Percutaneously Delivered
- Reason
- Due to a manufacturing issue which may result in cardiovascular balloon rupturing.
- Root cause
- Process change control
- Quantity
- 164
- Code info
- Lot Code: Model No.: 9880CM29A; UDI-DI: 00690103219777; Recalled Lot Number(s): 67718561, 67804014, 67887043, 67887044.
- 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
- Location
- Irvine, CA