Terumo Cardiovascular Systems Corporation

Complete recall history across all FDA and CPSC categories — 204 total recalls

Terumo Cardiovascular Systems Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (204)

FDA medical device enforcement actions by Terumo Cardiovascular Systems Corporation. Showing most recent 50.

Date Product Reason Class
May 28, 2025 CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Ca... Due to an error in assembly of the thermistor within some units, the affected... Class II
Mar 3, 2025 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Ca... During some clinical cases, it has been observed that the SO2 value may perio... Class II
Feb 20, 2024 Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A ... Pressure relief valve included in certain lots of cardiovascular procedure ki... Class II
Mar 1, 2023 CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor comp... Class II
Mar 1, 2023 CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor comp... Class II
Mar 1, 2023 CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor comp... Class II
Jun 8, 2021 Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #... intermittent failure causes a blender initialization fault upon start-up, or ... Class II
Apr 16, 2021 The Terumo HX2 Temperature Management System provides temperature control of ... Terumo CVS has been unable to validate a cleaning protocol to satisfy current... Class II
Apr 16, 2021 The Sarns Temperature Control and Monitor unit (TCM) is a source of temperatu... Terumo CVS has been unable to validate a cleaning protocol to satisfy current... Class II
Apr 16, 2021 The Sarns TCM II (system) is a source of temperature-controlled water for blo... Terumo CVS has been unable to validate a cleaning protocol to satisfy current... Class II
Mar 2, 2021 Consist of a distal connection mechanism (either standard Terumo Ball Quick C... There is a potential for the stainless steel locking plates on the device's s... Class II
Nov 11, 2020 (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir,... Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. W... Class II
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Ca... Internal testing at the supplier, revealed that a crimped wire was placed int... Class II
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed int... Class II
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed int... Class II
Jan 10, 2020 Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571... These roller pumps were assembled with pump shafts that may fail at the locat... Class II
Jan 10, 2020 Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 -... These roller pumps were assembled with pump shafts that may fail at the locat... Class II
Jan 10, 2020 Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570... These roller pumps were assembled with pump shafts that may fail at the locat... Class II
Jan 10, 2020 Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 -... These roller pumps were assembled with pump shafts that may fail at the locat... Class II
Jun 14, 2019 Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only... Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor comp... Class II
Jun 14, 2019 Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor comp... Class II
Jun 14, 2019 Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to... Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor comp... Class II
Jun 14, 2019 Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor comp... Class II
Apr 18, 2019 Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 8... The gas flow rate output of the EPGS may be inaccurate due to a defect in the... Class II
Dec 20, 2018 Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 Presence of natural rubber latex is not declared in the label Class II
Oct 17, 2018 Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Elec... An intermittent failure which causes a blender initialization fault upon star... Class II
Sep 13, 2018 Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#:... The service manual was not updated at the time of the release of software ver... Class II
Aug 31, 2018 VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX... The system's IFU contains a list of generators that the have been deemed comp... Class II
Aug 28, 2018 Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardi... Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the bas... Class II
Aug 28, 2018 Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardi... Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the bas... Class II
Jun 26, 2018 Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor ... H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat populatio... Class II
Jun 26, 2018 CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product U... H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat populatio... Class II
Mar 16, 2018 Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX... Update to cooler-heater cleaning instructions. Class II
Mar 16, 2018 Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling ... Update to cooler-heater cleaning instructions. Class II
Mar 16, 2018 Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00... Update to cooler-heater cleaning instructions. Class II
Jan 19, 2018 Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provi... Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue... Class II
Jun 27, 2017 Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a)... Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow th... Class II
Jun 27, 2017 TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow th... Class II
Feb 20, 2017 Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: ... Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Leve... Class II
Feb 20, 2017 Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage:... Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Leve... Class II
Jun 8, 2016 Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (sy... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall o... Class II
Jun 8, 2016 HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Managem... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall o... Class II
Jun 8, 2016 Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-He... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall o... Class II
Jun 8, 2016 Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a sour... Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall o... Class II
Mar 14, 2016 CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blo... Specific CDI¿ Blood Parameter Monitoring System 500 devices are being volunta... Class II
Dec 11, 2015 CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows:... Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI... Class III
Aug 7, 2015 CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line moni... Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium r... Class II
May 27, 2015 The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxi... Terumo Cardiovascular Systems Corporation has received complaints indicating ... Class II
May 1, 2015 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Pe... Terumo CVS is implementing field correction activities to address the identif... Class II
May 1, 2015 Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Pe... Terumo CVS is implementing field correction activities to address the identif... Class II

View all 204 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.