Terumo Cardiovascular Systems Corporation recalls
Every recall we track for Terumo Cardiovascular Systems Corporation — 38 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Terumo Cardiovascular Systems Corporation peaked in 2018 (12); 38 since 2017. 8% rated “stop using now”.
All FDA recall records for Terumo Cardiovascular Systems Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 1 | 0 | 2 |
| 2018 | 0 | 3 | 9 | 0 | 12 |
| 2019 | 0 | 1 | 3 | 1 | 5 |
| 2020 | 0 | 4 | 3 | 1 | 8 |
| 2021 | 3 | 2 | 0 | 0 | 5 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 2 | 1 | 0 | 3 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Terumo Cardiovascular Systems Corporation recalls
What to do if you have a recalled Terumo Cardiovascular Systems Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Terumo Cardiovascular Systems Corporation recalls
21 shown- Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial
Terumo recalls CDI OneView BPM Probes with potential temperature measurement errors that could lead to incorrect patient vital signs. Affected units have specific serial numbers and model numbers. Consumers should contact Terumo for details.
TerumoMay 28, 2025 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo recalls hematocrit/oxygen probes with specific serial numbers due to occasional dashed SO2 values causing false low-limit alarms. Affected units may need verification.
TerumoMar 3, 2025 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312
Terumo recalls cardiovascular procedure kits with specific part numbers that may cause pressure relief valve to open at 200-300mmHg instead of 400mmHg, potentially causing myocardial tissue damage requiring surgery.
TerumoFeb 20, 2024 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Terumo recalls CAPIOX NX19 Hollow Fiber Oxygenators with specific catalog numbers due to potential leak at arterial thermistor connection. Affected units may need repair or replacement.
TerumoMar 1, 2023 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #801: 801188) due to intermittent failure causing blender initialization faults during calibration. Affected units may have disabled control sliders.
TerumoJun 8, 2021 - Stop using nowMedical device
Terumo Cardiovascular Systems Corporation recalls The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an
Terumo recalls Sarns TCM II blood heat exchangers due to inability to validate cleaning protocols. Affected units must be discontinued and disposed of to prevent potential safety risks.
TerumoApr 16, 2021 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an
Terumo recalls specific stent retractors with potential stainless steel locking plates that could fracture, causing injury during surgery. Affected models include T401163 with serial numbers T00393-T00412.
TerumoMar 2, 2021 - UnratedMedical device
Terumo Cardiovascular Systems Corporation recalls (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog
Terumo recalls Capiox FX25 Advance Oxygenators with incorrect East/West configuration for heart surgery. This may cause improper gas exchange during cardiopulmonary bypass. Affected units have specific catalog numbers and lot numbers.
TerumoNov 11, 2020 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for
Terumo recalls air sensors for extracorporeal procedures due to wiring causing false alarms. Check serial numbers 20019-20020 for affected units.
TerumoAug 25, 2020 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for
Terumo recalls specific roller pumps that may fail due to noise, risking pump stoppage during blood circulation procedures. Affected units have serial numbers starting with 880559-882813 and 885541-885543.
TerumoJan 10, 2020 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Terumo recalls oxygenator model 3CX*NX19RE with possible non-functioning thermistor that could cause oxygen delivery issues. Affected units sold in 2017 with lot number WP17.
TerumoJun 14, 2019 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (Catalog # 801188) due to potential inaccurate gas flow rates, which could affect patient safety during medical procedures.
TerumoApr 18, 2019 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Terumo recalls Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) due to natural rubber latex not being declared on label. Affected units have catalog number 140222 and lot numbers V A30.
TerumoDec 20, 2018 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) due to intermittent failure causing control sliders to disable during calibration. Affected units have specific catalog numbers and UDI codes.
TerumoOct 17, 2018 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System due to outdated service manual for software version 1.30. Affected units may have safety risks.
TerumoSep 13, 2018 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus
Terumo recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System (VSP550EX) due to a generator compatibility issue that could affect surgical safety. Affected units may require specific generator checks.
TerumoAug 31, 2018 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog
Terumo recalls specific models of Advanced Perfusion System Platform for cardiopulmonary bypass use due to potential electrical short from improperly torqued screws. Affected units may need repair or replacement.
TerumoAug 28, 2018 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous,
Terumo recalls CDI Blood parameter monitoring system 500 H/SAT with Part No. 145883 due to Color Chip Test failures that disable the H/Sat module. No device inaccuracy occurs.
TerumoJun 26, 2018 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated
Terumo recalls Sarns TCM II temperature monitors with specific catalog numbers for updated cleaning instructions to prevent potential issues.
TerumoMar 16, 2018 - Lower riskMedical device
Terumo Cardiovascular Systems Corporation recalls Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and
Terumo recalls Flowmeter Module (accessory for Advanced Perfusion System 1) due to inaccurate flow readings that may not be easily detected during setup or use. Affected units have specific serial numbers.
TerumoJan 19, 2018 - Use cautionMedical device
Terumo Cardiovascular Systems Corporation recalls TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Terumo recalls overpressure safety valves (LH130/LH130J) with no flow reported. Affected units have specific lot codes and distribution dates. Stop using if no flow occurs.
TerumoJun 27, 2017
Terumo Cardiovascular Systems Corporation recall questions
How many recalls has Terumo Cardiovascular Systems Corporation had?
38 recalls from Terumo Cardiovascular Systems Corporation are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Terumo Cardiovascular Systems Corporation recall?
Terumo Cardiovascular Systems Corporation recalls CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial, dated May 28, 2025. Every Terumo Cardiovascular Systems Corporation recall is listed on this page, newest first.
Why are Terumo Cardiovascular Systems Corporation products recalled?
The most common reasons on record: Update to cooler-heater cleaning instructions. (3).
What should I do if I have a recalled Terumo Cardiovascular Systems Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Terumo Cardiovascular Systems Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.