Home › Device types › DTW
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
FDA product code DTW · Class 2 · Cardiovascular
10
Registered devices
153
Adverse events
15
Recalls
17
510(k) clearances
Devices with this code
Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationAnivia SG1000 Pump Console — APMTD, Inc.Level 1 — ICU MEDICAL, INC.Level 1 — ICU MEDICAL, INC.Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationLevel 1 — ICU MEDICAL, INC.Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-01-12 | Terumo Cardiovascular Systems Corp | 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 replac |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | 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 replac |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | 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 replac |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | 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 replac |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | 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 replac |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
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