MNJClass II

Valve, Pressure Relief, Cardiopulmonary Bypass

Cardiovascular · 21 CFR 870.4400

MDR events66All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances2All time

Recent MDR events

66 adverse event reports on file

TRANSFORM SUPER COMPLIANT 4MM X 10MM- CEDec 22, 2022
MalfunctionStryker Neurovascular Cork3008881809-2022-00644
WILLIAM HARVEY OVER PRESSURE SAFETY VALVEAug 19, 2009
MalfunctionTerumo Cardiovascular Systems Corp.1124841-2009-00029
TERUMO OVERPRESSURE SAFETY VALVEFeb 5, 2009
Injury*1124841-2009-00002
*Jan 27, 2009
InjuryTerumo Cardiovascular Systems Corp.1298803
VACUUM RELIEF VALVE IIC--CLEARSep 19, 2006
MalfunctionQuest Medical, Inc.1649914-2006-00098
VACUUM RELIEF VALVE IIC-CLEARMay 16, 2006
MalfunctionQuest Medical, Inc.1649914-2006-00047
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVEApr 3, 2006
MalfunctionMedtronic Perfusion Systems2184009-2006-00028
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVEMar 29, 2006
MalfunctionMedtronic Perfusion Systems2184009-2006-00024
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVEMar 25, 2005
MalfunctionMedtronic Perfusion Systems2184009-2005-00024
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVEMar 25, 2005
MalfunctionMedtronic Perfusion Systems2184009-2005-00025

Event type breakdown

Malfunction56

Injury7

Other2

Unspecified1

Most-reported manufacturers

Quest Medical, Inc.38 Medtronic Perfusion Systems9 Bard Vascular System6 Unspecified2 Bird Products Corp.2 Terumo Cardiovascular Systems Corp.2 *1 C.r. Bard, Inc.1

Recalls

1 recall events for this product code

Terumo Cardiovascular Systems Corporation
TerminatedDec 27, 2013
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Z-0603-2014 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

2 clearances for this product code