FDA recall, , High risk
Edwards Lifesciences Commander M Delivery System
The Edwards Commander M Delivery System may have a manufacturing issue causing cardiovascular balloon rupturing.
Summary by Recall Canary from the FDA notice
What happened
Edwards Lifesciences, LLC, of Irvine, California, voluntarily recalled the Edwards Commander M Delivery System, model 9880CM29A, because a manufacturing issue may result in cardiovascular balloon rupturing. The firm initiated the recall on October 5, 2026, and it was added to the FDA's Enforcement Report on November 2, 2026.
The recall was distributed by letter to customers in Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Edwards Commander M Delivery System
- Model number
- 9880CM29A
- Lot code
- 67718561
- 67804014
- 67887043
- 67887044
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
U.S.: Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington. O.U.S.: N/A
- Recalled by
- Edwards Lifesciences, LLCIrvine, California
- Hazard
- Manufacturing problem
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- FDA event number
- 100067
- Recall number
- Z-0287-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Edwards Lifesciences, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Edwards Lifesciences began the recall
FDA posted the recall to its Enforcement Report and rated it Class I (high risk)
Added to Recall Canary
