Sizer, Heart-valve, Prosthesis
Cardiovascular · 21 CFR 870.3945
Recent MDR events
200 adverse event reports on file
- MECHANICAL SIZER SETJun 15, 2026MalfunctionAbbott Medical2135147-2026-04103
- MECHANICAL SIZER SETJun 8, 2026MalfunctionAbbott Medical2135147-2026-03871
- MECHANICAL SIZER SETJun 8, 2026MalfunctionAbbott Medical2135147-2026-03869
- MECHANICAL SIZER SETJan 13, 2026MalfunctionAbbott Medical2135147-2026-00270
- EDWARDS HEART VALVE SIZERDec 29, 2025InjuryEdwards Lifesciences2015691-2025-10614
- PERIMOUNTMAGNA SIZERAug 16, 2024InjuryEdwards Lifesciences2015691-2024-06198
- EDWARDS HEART VALVE SIZERAug 16, 2024MalfunctionEdwards Lifesciences2015691-2024-06201
- BIOCOR/EPIC SIZER SETJun 10, 2024InjuryAbbott Medical2135147-2024-02705
- PERIMOUNT MAGNA EASE SIZER SETMay 10, 2024MalfunctionEdwards Lifesciences2015691-2024-03502
- BIOCOR/EPIC SIZER SETMar 18, 2024MalfunctionAbbott Medical2135147-2024-01200
Event type breakdown
Recalls
2 recall events for this product code
- Medtronic CoreValve LLCOpen, ClassifiedFeb 14, 2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
Z-1449-2020 · View FDA record ↗ - Medtronic CoreValve LLCOpen, ClassifiedFeb 14, 2020
Medtronic
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
Z-1450-2020 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Life Science Outsourcing, Inc.
Brea, CA, US
Abbott Medical
Plymouth, MN, US
Medtronic Heart Valves Division
Santa Ana, CA, US
Edwards Lifesciences Llc
Draper, UT, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Isomedix Operations Inc.
Sandy, UT, US
Sanamedi, Inc.
Chuo-ku Tokyo, JP
Tokyo Research Center For Advanced Surgical Technology Co., Ltd.
Meguro Tokyo, JP
Fehling Instruments Gmbh
KARLSTEIN Bavaria, DE
Corcym S.r.l.
SALUGGIA Vercelli, IT
Genesee Biomedical, Inc.
DENVER, CO, US
Artivion, Inc.
Kennesaw, GA, US
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Teleflex Llc (nadc)
Olive Branch, MS, US
On-x Life Technologies Inc.
Austin, TX, US
Tochigi Seiko Co., Ltd
Tochigi-shi, JP
Abbott Medical
Saint Paul, MN, US
Edwards Lifesciences Llc
IRVINE, CA, US
Teleflex Medical Llc
Morrisville, NC, US
St. Jude Medical Brasil Ltda.
Belo Horizonte Minas Gerais, BR
Geister Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
510(k) clearances
7 clearances for this product code
- Carbomedics, Inc.Nov 29, 1995
K952184 · CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
- Carbomedics, Inc.Dec 10, 1993
K934951 · VALVE SIZER
- Baxter Healthcare CorpMay 18, 1988
K881279 · EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
- Hemex Scientific, Inc.Nov 1, 1985
K853313 · DUROMEDICS CARDIAC VALVE SIZER SET
- Medtronic VascularSep 23, 1985
K852612 · METRONIC MODEL F7700 HEART VALVE SIZERS
- CeltechJul 8, 1982
K820887 · MITRAL VALVE ORIFICE SIZER
- Hancock Laboratories, Inc.Sep 9, 1980
K801885 · HANCOCK * OBTURATORS