Edwards Lifesciences, Llc: Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/catalog Number: 9880cm29a Software Versio...
- Recalling firm
- Edwards Lifesciences, LLC
- 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
- Reason
- Due to a manufacturing issue which may result in cardiovascular balloon rupturing.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-10-05
- Status
- Ongoing
- Areas affected
- AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, ...
- 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
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/140f901a-2b49-4ced-8fe4-e60f876f2622