Home › Device types › DTR
Heat-Exchanger, Cardiopulmonary Bypass
FDA product code DTR · Class 2 · Cardiovascular
232
Registered devices
858
Adverse events
33
Recalls
91
510(k) clearances
Devices with this code
Cardiovascular Procedure Kit — Terumo Cardiovascular Systems CorporationQuantum — SPECTRUM MEDICAL LIMITEDMPS 3 Arrest Cartridge — QUEST MEDICAL INCMPS Console Adapter (S-8000 HLM) — QUEST MEDICAL INCMPS Delivery Set — QUEST MEDICAL INCVanguard — SORIN GROUP ITALIA SRLMPS 3 Power cord — QUEST MEDICAL INCECMOtherm- II™ — MEDTRONIC, INC.MYOtherm XP™ — MEDTRONIC, INC.Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M — SPECTRUM MEDICAL SRLCardiovascular Procedure Kit — Terumo Cardiovascular Systems CorporationMPS 3 Console Pole Mount — QUEST MEDICAL INCCardiovascular Procedure Kit — Terumo Cardiovascular Systems CorporationQuantum PureFlow Standard Heat Exchanger Low Flow 1/4 — SPECTRUM MEDICAL SRLCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationVanguard — SORIN GROUP ITALIA SRLQuantum PureFlow Standard Heat Exchanger High Flow 3/8 W — SPECTRUM MEDICAL SRLSarns™ Cardioplegia Set — Terumo Cardiovascular Systems CorporationGOODWIN LUNG LINE — NOVOSCI CORP.MPS 3 Mini Prime Delivery Set w/AA — QUEST MEDICAL INCMPS2 Console — QUEST MEDICAL INCCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationCapiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems CorporationCARDIOPLEGIA ADMINISTRATION SET — NOVOSCI CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-18 | Maquet Medical Systems USA | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, |
| 2019-12-17 | Quest Medical, Inc. | Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat |
| 2015-10-28 | Quest Medical, Inc. | The products have been found to intermittently exhibit a seal failure during use. |
| 2014-01-31 | Maquet Cardiovascular Us Sales, Llc | The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardiopl |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line |
| 2010-07-29 | Quest Medical, Inc | User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. |
| 2010-06-08 | Terumo Cardiovascular Systems Corp | Vent port may be occluded and prevent delivery of fluid |
| 2010-06-08 | Terumo Cardiovascular Systems Corp | Vent port may be occluded and prevent delivery of fluid |
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