Sorin Group Italia S.r.l. recalls Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: h…

Recall date

July 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2986-2020

FDA classification

Class II

Brand / firm

Sorin Group Italia S.r.l.

Sold / distributed

US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA, WA, WI and the countries of Canada, Japan, Germany, Netherland, Switzerland, Sweden, UK, Spain, Italy, France, Belgium, Finland, Greece, Slovenia, Malta, Poland, Romania, Croatia, H…

Why it was recalled

LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.