FDA Device Intelligence
Home › Device types › DRY

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA product code DRY · Class 2 · Cardiovascular

126
Registered devices
5,034
Adverse events
40
Recalls
47
510(k) clearances

Devices with this code

Quantum — SPECTRUM MEDICAL LIMITEDB-CAPTA — SORIN GROUP ITALIA SRLB-CAPTA — SORIN GROUP ITALIA SRLCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationSystem M ® — SPECTRUM MEDICAL LIMITEDBMU 40 — Maquet Cardiopulmonary AGCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationQuantum — SPECTRUM MEDICAL LIMITEDTMC38 — MEDTRONIC, INC.CDI™ H/S Cuvette 1/4 x 1/4 with Extension — Terumo Cardiovascular Systems CorporationBMU 40 — Maquet Cardiopulmonary AGCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationQuantum ® System M ® — SPECTRUM MEDICAL LIMITEDBMU 40 — Maquet Cardiopulmonary AGQuantum — SPECTRUM MEDICAL LIMITEDBMU 40 — Maquet Cardiopulmonary AGVirtual Kit Number — LivaNova Deutschland GmbHB-Capta — LivaNova Deutschland GmbHSystem M ® — SPECTRUM MEDICAL LIMITEDQuantum ® — SPECTRUM MEDICAL LIMITEDCDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems CorporationECG Cables and Leadsets — Philips Medical Systems HsgCDI OneView™ Monitoring System — Terumo Cardiovascular Systems CorporationCDI OneView™ Monitoring System — Terumo Cardiovascular Systems Corporation

Recent recalls

DateFirmReason
2025-05-28Terumo Cardiovascular Systems CorporationDue to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additional
2025-03-03Terumo Cardiovascular Systems CorporationDuring some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data.
2020-09-30Maquet Cardiovascular Us Sales, LlcThe Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were de
2018-06-26Terumo Cardiovascular Systems CorporationH/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test w
2018-06-26Terumo Cardiovascular Systems CorporationH/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test w
2016-03-14Terumo Cardiovascular Systems CorporationSpecific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the b
2015-12-11Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the
2015-08-07Terumo Cardiovascular Systems CorporationInaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
2014-05-09Terumo Cardiovascular Systems CorporationThere is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with l
2013-02-27Terumo Cardiovascular Systems CorporationTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, an

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.