Ann Arbor, MI, United States
Terumo Cardiovascular Systems Corporation recalls
23 recalls recorded since 2018, most recently on 28 May 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls23
Ongoing (FDA)4
Terminated or completed19
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 May 2025
- Reason
- Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
- Distribution
- US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2018-2025
- CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Ongoing Class II Medical devices
- Recall started
- 3 March 2025
- Reason
- During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
- Distribution
- US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1492-2025
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Ongoing Class II Medical devices
- Recall started
- 20 February 2024
- Reason
- Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
- Distribution
- worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1401-2024
- Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 748
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
- Distribution
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1346-2023, Z-1347-2023, Z-1345-2023
- CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
- CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
- CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Terminated Class II Medical devices
- Recall started
- 3 February 2022
- Terminated
- 20 February 2024
- Reason
- Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
- Distribution
- US Nationwide distribution in the states of CA and IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0949-2022
- Cardiovascular Procedure Kit catalog # 76645 & 73806
Terminated Class II Medical devices
- Recall started
- 8 June 2021
- Terminated
- 28 June 2022
- Reason
- intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
- Distribution
- International distribution in the country of Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2350-2021
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terminated Class II Medical devices
- Recall started
- 16 April 2021
- Terminated
- 29 November 2023
- Reason
- Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
- Distribution
- Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1791-2021, Z-1790-2021, Z-1789-2021
- The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice
- The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TC
- The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
Terminated Class II Medical devices
- Recall started
- 2 March 2021
- Terminated
- 5 November 2021
- Reason
- There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
- Distribution
- US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1367-2021
- Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the devic
Terminated Class II Medical devices
- Recall started
- 11 November 2020
- Terminated
- 22 November 2021
- Reason
- Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
- Distribution
- US Nationwide Foreign: Belgium, India
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0565-2021
- (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Re
Terminated Class II Medical devices
- Recall started
- 25 August 2020
- Terminated
- 29 January 2021
- Reason
- Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2961-2020, Z-2959-2020, Z-2960-2020
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubble
Terminated Class II Medical devices
- Recall started
- 10 January 2020
- Terminated
- 12 May 2020
- Reason
- These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1111-2020, Z-1108-2020, Z-1110-2020, Z-1109-2020
- Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, a
- Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion,
- Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmon
- Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion,
Terminated Class II Medical devices
- Recall started
- 14 June 2019
- Terminated
- 11 June 2020
- Reason
- Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Distribution
- MI Foreign: Japan, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2101-2019, Z-2104-2019, Z-2102-2019, Z-2103-2019
- Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
- Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
- Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
- Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Terminated Class II Medical devices
- Recall started
- 18 April 2019
- Terminated
- 20 May 2020
- Reason
- The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1337-2019
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas inpu
Terminated Class II Medical devices
- Recall started
- 20 December 2018
- Terminated
- 20 August 2019
- Reason
- Presence of natural rubber latex is not declared in the label
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0966-2019
- Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Terminated Class II Medical devices
- Recall started
- 17 October 2018
- Terminated
- 30 April 2020
- Reason
- An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
- Distribution
- Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1769-2019
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Terminated Class II Medical devices
- Recall started
- 13 September 2018
- Terminated
- 18 November 2019
- Reason
- The service manual was not updated at the time of the release of software version 1.30.
- Distribution
- US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0176-2019
- Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Terminated Class II Medical devices
- Recall started
- 31 August 2018
- Terminated
- 21 October 2019
- Reason
- The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU.
- Distribution
- Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0227-2019
- VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowi
Terminated Class II Medical devices
- Recall started
- 28 August 2018
- Terminated
- 23 April 2020
- Reason
- Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
- Distribution
- Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3243-2018, Z-3242-2018
- Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
- Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Terminated Class II Medical devices
- Recall started
- 26 June 2018
- Terminated
- 17 April 2020
- Reason
- H/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 which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, SC, TN, TX, WA, and WV. Foreign distribution to Middle East, Latin America, Europe, Japan, Canada, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2750-2018, Z-2751-2018
- CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, pota
- Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of
Terminated Class II Medical devices
- Recall started
- 16 March 2018
- Terminated
- 10 June 2020
- Reason
- Update to cooler-heater cleaning instructions.
- Distribution
- Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1418-2018, Z-1417-2018, Z-1416-2018
- Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
- Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
- Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Terminated Class II Medical devices
- Recall started
- 19 January 2018
- Terminated
- 18 July 2018
- Reason
- Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
- Distribution
- Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1478-2018
- Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Terminated Class II Medical devices
- Recall started
- 18 December 2017
- Terminated
- 9 April 2019
- Reason
- Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
- Distribution
- US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1314-2018
- Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Bl
Terminated Class II Medical devices
- Recall started
- 12 May 2017
- Terminated
- 26 October 2018
- Reason
- Kit was labeled with the incorrect Expiration Date of April 30, 2019.
- Distribution
- US state of FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2550-2018
- Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.