Reported Dec 14, 2016 · Terminated
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size…
Sorin Group USA, Inc.
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: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
PVS21 | Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208 |
PVS23 | Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209 |
PVS25 | Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210 |
PVS27. | Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. |
- Lot codes and dates
- All Lots
- Amount recalled
- 845 units
Where it was sold
Why it was recalled
Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
This product could cause temporary or reversible health problems — stop using it.
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