Reported Feb 20, 2019 · Terminated
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 S Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930
8 of 8 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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 |
- Lot codes and dates
- (ALL LOTS Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US)
006901031939619600LDS29J006901031948839610TF20006901031929959610TF23006901031904589610TF26006901031904659610TF2900690103193008
- (ALL LOTS Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US)
- Amount recalled
- 159,448 units
Why it was recalled
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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