Every recall we track for Terumo Cardiovascular Systems Corporation — 38 in all — plus the complaints and injury reports the public filed about them.
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.
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.
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.
Terumo recalls CAPIOX RX15 Hollow Fiber Oxygenators with specific catalog numbers due to potential leak at arterial thermistor connection. Affected units may need repair or replacement.
Terumo recalls CAPIOX FX25 Hollow Fiber Oxygenators with specific catalog numbers due to potential leak risk from improperly bonded arterial thermistor components.
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.
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.
Terumo recalls HX2 Temperature Management System (P/N 809810) from 1985-2015 due to inability to validate cleaning protocol. Users must stop using and dispose of devices to prevent potential safety risks.
Terumo recalls Sarns Temperature Control and Monitor units (TCM) due to unvalidated cleaning protocol. Affected units from 1985-2015 may cause infection if not cleaned properly. Discontinue use and dispose of affected models.
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.
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.
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.
Terumo recalls a specific air sensor used in medical procedures due to potential false air bubble alarms from a wiring issue. Affected units have catalog number 5785 and serial numbers starting with 20230.
Terumo recalls specific air sensors for extracorporeal procedures due to a crimped wire causing false air bubble alarms. Affected units have serial numbers starting with 20288-20579.
Terumo recalls air sensors for extracorporeal procedures due to wiring causing false alarms. Check serial numbers 20019-20020 for affected units.
Terumo recalls 6-inch Advanced Perfusion System 1 Roller Pump (catalog 816571) due to potential shaft failure causing noise and pump stoppage during blood circulation procedures.
Terumo recalls specific roller pumps that may fail due to unusual noise, risking pump stoppage during blood circulation procedures. Affected units have serial numbers starting with 882298.
Terumo recalls 4-inch roller pumps with potential shaft failure causing noise and pump stoppage during blood circulation procedures. Affected units have specific serial numbers and catalog numbers.
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.
Terumo recalls specific Japanese-exported Capiox NX19 Oxygenators due to potential non-functioning arterial thermistor. Affected units sold only in Japan with lot numbers XA28, XC12, XC25, XD05, XD27.
Terumo recalls oxygenator model 3CX*NX19RW with possible non-functioning thermistor. Affected units may not monitor blood temperature correctly.
Terumo recalls specific Japanese-exported Capiox NX19 Oxygenators with non-functioning arterial thermistor components. Affected units have lot numbers XA21, XA29, XC04, XC18, XD05, XD27. Consumers should contact Terumo for details.
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.
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.
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.
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.
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.
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.
Terumo recalls specific models of Advanced Perfusion System Platform for cardiopulmonary bypass procedures due to potential electrical short from improperly torqued screws.
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.
Terumo recalls specific blood monitoring devices due to H/Sat Color Chip Test failures, which disable the H/Sat module but do not affect device accuracy.
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.
Terumo recalls HX2 Temperature Management System (Catalog No. 809810) due to updated cleaning instructions for open heart surgery use. All units are affected.
Terumo recalls Sarns TCM temperature monitors (Catalog No. 15747) due to updated cleaning instructions for safety. All units are affected.
Terumo recalls Sarns TCM II temperature monitors with specific catalog numbers for updated cleaning instructions to prevent potential issues.
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.
