Reported Jan 20, 2021 · Terminated
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Lot codes and dates
- GTIN 08714729940814, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021
- Amount recalled
- 207 devices
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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