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TERUMO CARDIOVASCULAR SYSTEM CORP

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 21, 2011

HERCULES 360

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·August 11, 2014

SHUNT SENSOR SYS500

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 5, 2015

VIRTUOSAPH PLUS, EVH

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·August 11, 2014

HE CONDUCER POTTED (PACKAGED)

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·September 15, 2014

VALVE, O.P.S. BULK, N-S

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTL·March 14, 2013

FX OXY W/O RESERVOIR

FDA Adverse Event
Malfunction ·TERUMO CORP, ASHITAKA·Product code DTZ·October 14, 2014

SX OXYGENATOR W/ HR (STERILE)

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·June 8, 2015

1124841-2015-00169

FDA Adverse Event
Malfunction ·May 19, 2015

SHUNT SENSOR SYS500

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 26, 2014

SX OXYGENATOR W/HR (STERILE)

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·August 26, 2014

HERCULES 360

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code MWS·July 8, 2014

CAPIOX RX25 OXYGENATOR EAST

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·May 20, 2015

STERILE FX25RW OX W/ RES

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·May 14, 2015

HERCULES 360

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code MWS·January 22, 2015

BULK NON STER XCOAT DELPH PUMP

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·April 16, 2015

SHUNT SENSOR SYS500

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·December 18, 2014

CAPIOX RX25 OXYGENATOR EAST

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·February 17, 2015

SHUNT SENSOR SYS500

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 17, 2015

VIRTUOSAPH PLUS

FDA Adverse Event
Injury ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·May 16, 2014