Edwards Commander Delivery System Recalled for Balloon Component Separation
Edwards Lifesciences is recalling the Edwards Commander Delivery System due to reports of crimp and inflation balloon component separation during TAVR procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (component separation) during a high-risk surgical procedure, which poses a risk of harm even without reported injuries.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Edwards Commander Delivery System, a medical device used in Transcatheter Aortic Valve Replacement (TAVR) procedures. The recall covers 159,448 units distributed worldwide.
The action was initiated to address complaint reports regarding the separation of the crimp balloon and inflation balloon components during TAVR procedures. The device is indicated for use in patients with severe, symptomatic, calcific aortic stenosis.
Healthcare providers and patients should contact Edwards Lifesciences for further instructions on how to proceed with the recall and replacement of affected units.
The recalled product
- Product
- Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US)…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 159,448
Distribution
Distribution scope not specified by the agency.
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