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Heat-Exchanger, Cardiopulmonary Bypass

FDA product code DTR · Class 2 · Cardiovascular

235
Registered devices
859
Adverse events
35
Recalls
91
510(k) clearances

Devices with this code

Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems CorporationCardiovascular Procedure Kit — Terumo Cardiovascular Systems CorporationMPS 3 ND Delivery Set w/AA w/106cm (16C) — QUEST MEDICAL INCQuantum PureFlow Standard Heat Exchanger High Flow 3/8 M — SPECTRUM MEDICAL SRLMPS Console Adapter (S-8000 HLM) — QUEST MEDICAL INCQUADROX-i — Maquet Cardiopulmonary AGMPS Console Adapter (Jostra) — QUEST MEDICAL INCQUADROX-i — Maquet Cardiopulmonary AGMPS 3 Mini Prime Delivery Set w/AA w/o Line — QUEST MEDICAL INCQuantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - PL — SPECTRUM MEDICAL SRLMPS 3 Delivery Set w/AA w/106cm (10C) — QUEST MEDICAL INCCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationNA — Maquet Cardiopulmonary AGMPS — QUEST MEDICAL INCNX19 Oxygenator w/4-liter reservoir; right-side outlet port — Terumo Cardiovascular Systems CorporationQuantum PureFlow Standard Heat Exchanger Low Flow 3/16 — SPECTRUM MEDICAL SRLMPS 3 Delivery Set w/183cm (16C) — QUEST MEDICAL INCNA — Maquet Cardiopulmonary AGMPS Console Adapter, base mount — QUEST MEDICAL INCMPS Stand Alone Cart — QUEST MEDICAL INCMPS 3 Arrest Cartridge — QUEST MEDICAL INCAortic Root Transducer Interface Cable (Antegrade) — QUEST MEDICAL INCNA — Maquet Cardiopulmonary AGSarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation

Recent recalls

DateFirmReason
2026-07-17SPECTRUM MEDICAL SRLDue to blood-to-glycol leak in the heat exchanger.
2026-07-17SPECTRUM MEDICAL SRLDue to blood-to-glycol leak in the heat exchanger.
2023-05-18Maquet Medical Systems USA1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes,
2019-12-17Quest 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
2015-10-28Quest Medical, Inc.The products have been found to intermittently exhibit a seal failure during use.
2014-01-31Maquet Cardiovascular Us Sales, LlcThe MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardiopl
2011-03-01Terumo Cardiovascular Systems CorpDefect 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
2011-03-01Terumo Cardiovascular Systems CorpDefect 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
2011-03-01Terumo Cardiovascular Systems CorpDefect 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
2010-07-29Quest Medical, IncUser update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.