Edwards Commander M delivery system recalled for balloon rupture risk
Edwards Lifesciences is recalling 164 Commander M Delivery Systems, model 9880CM29A, from four lots. A manufacturing issue may cause the cardiovascular balloon to rupture. The notice reports no injuries.
From the FDA notice · Read the official notice ↗
What to do
- Check inventory for model 9880CM29A, lots 67718561, 67804014, 67887043 or 67887044 (UDI-DI 00690103219777), and set affected units aside.
- Contact Edwards Lifesciences about the recall. The notice doesn't say how to return or replace units, so ask the manufacturer for instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- 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
- Made for
- Adults (18 years to 120 years)
Details
- Units affected
- 164
- Illnesses reported
- None reported
- Manufactured in
- 1 Edwards Way, Irvine, California, United States
- Classification
- Class I
- Recall number
- Z-0287-2027
In the FDA's words
- Description
- 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 Due to a manufacturing issue which may result in cardiovascular balloon rupturing. 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 Affected quantity: 164
- Hazard
- Due to a manufacturing issue which may result in cardiovascular balloon rupturing.