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 |
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.
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