Recall record at a glance
| Official record | Z-0835-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Edwards Lifesciences, LLC |
| Report date | Feb 20, 2019 |
| Recall initiation date | Jan 22, 2019 |
| Quantity | 159,448 units |
| Location | Draper, UT, United States |
Official product description
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) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis
Why the product was recalled
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
Distribution information
WorldwideDistribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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