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MOSAIC®

MEDTRONIC, INC. · Model 305C227 · UDI-DI 00613994479020

LWR Prescription
0
510(k) clearances
25,471
Adverse events (2,037 deaths)
7
Recalls
22
Facilities

Description

VALVE 305C227 MOSAIC AOR CINCHII US

Recalls

DateFirmReason
2020-07-29Sorin Group Italia S.r.l.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 u
2020-07-29Sorin Group Italia S.r.l.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 u
2020-07-29Sorin Group Italia S.r.l.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 u
2020-07-29Sorin Group Italia S.r.l.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 u
2020-07-29Sorin Group Italia S.r.l.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 u
2016-10-31Sorin Group USA, Inc.Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
2014-01-09Medtronic Cardiovascular Surgery-the Heart Valve DivisionMedtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expe

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.