Recall record at a glance
| Official record | Z-0716-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Sorin Group USA, Inc. |
| Report date | Dec 14, 2016 |
| Recall initiation date | Oct 31, 2016 |
| Quantity | 845 units |
| Location | Arvada, CO, United States |
Official product description
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Why the product 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.
Distribution information
Worldwide Distribution-US (Nationwide) including states of: MD, ME, MA, NH, NY, NJ, AL, MS, VA, FL, CA, HI, TN, GA, WI, TX, MI, OH, KS, MN, NC, IL, IN, WA MO, PA, NM, and UT and countries of: Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Jordan, India, Italy, Iran, Islamic Republic of, Ireland, Israel, Korea, Republic of, Kuwait, Luxembourg, Malaysia, Malta, Mexico, Netherland, New Zealand, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South African, Spain, Switzerland, Romania, Russian Federation,Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
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
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