Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
FDA adverse event reports and recall history for monitor and/or control, level sensing, cardiopulmonary bypass (product code DTW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 153
- Deaths
- 0
- Injuries
- 4
- Malfunctions
- 121
Reports per year
Source: FDA adverse event reports by year received, 2000–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2007-03-27TerminatedOther
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- 2007-03-27TerminatedOther
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- 2007-03-27TerminatedOther
Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- 2007-03-27TerminatedOther
Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- 2007-03-27TerminatedOther
Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
- 2006-12-07TerminatedOther
Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280.
The hand crank handle may separate and detach from the unit during use.
- 2006-12-07TerminatedOther
Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290.
The hand crank handle may separate and detach from the unit during use.
- 2006-12-07TerminatedOther
Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300.
The hand crank handle may separate and detach from the unit during use.
- 2006-12-07TerminatedOther
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
The hand crank handle may separate and detach from the unit during use.
- 2006-12-07TerminatedOther
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
The hand crank handle may separate and detach from the unit during use.
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