Home › Device types › LWR
Heart-Valve, Non-Allograft Tissue
FDA product code LWR · Class 3 · Unknown
373
Registered devices
25,471
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
HANCOCK II ULTRA® — MEDTRONIC, INC.PERCEVAL S — CORCYM SRLTrifecta™ — ST. JUDE MEDICAL, INC.Biocor™ — ST. JUDE MEDICAL, INC.MOSAIC ULTRA® — MEDTRONIC, INC.PERCEVAL S — CORCYM SRLMOSAIC ULTRA® — MEDTRONIC, INC.Trifecta™ — ST. JUDE MEDICAL, INC.PERCEVAL S — CORCYM SRLHancock™ 150 — MEDTRONIC, INC.Biocor™ — ST. JUDE MEDICAL, INC.Epic™ — ST. JUDE MEDICAL, INC.FREESTYLE® — MEDTRONIC, INC.MITRIS RESILIA Mitral Valve — Edwards Lifesciences LLCEDWARDS INTUITY ELITE DELIVERY SYSTEM — Edwards Lifesciences LLCAvalus™ — MEDTRONIC, INC.PERCEVAL — Corcym Canada CorpFREESTYLE® — MEDTRONIC, INC.HANCOCK II ULTRA® — MEDTRONIC, INC.3f® — MEDTRONIC 3F THERAPEUTICS, INC.MOSAIC® — MEDTRONIC, INC.MOSAIC® — MEDTRONIC, INC.KONECT RESILIA — Edwards Lifesciences LLCMOSAIC ULTRA® — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-07-29 | Sorin 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 |
| 2020-07-29 | Sorin 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 |
| 2020-07-29 | Sorin 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 |
| 2020-07-29 | Sorin 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 |
| 2020-07-29 | Sorin 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 |
| 2016-10-31 | Sorin 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 |
| 2014-01-09 | Medtronic Cardiovascular Surgery-the Heart Valve Division | Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because |
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