Terumo Cardiovascular Systems Corporation
Ann Arbor, MI
This page shows every FDA and USDA recall linked to Terumo Cardiovascular Systems Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
336
Total Recalls
2007
First Recall
2025
Most Recent
CDI OneView System BPM Probe:
Cat. No. CDI753 - CDI OneView BPM Probe,
Cat. No. CDI753TK - CDI OneView BPM Pr...
Jun 24, 2025
· Device
Open, Classified
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Mar 31, 2025
· Device
Open, Classified
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A
Part Number:
6375
16010
62974
652...
Mar 29, 2024
· Device
Open, Classified
Terumo Advanced Perfusion System 1 Electronic Patient Gas System
Catalog #: 801188
Jun 8, 2021
· Device
Terminated
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood hea...
Apr 16, 2021
· Device
Terminated
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits th...
Apr 16, 2021
· Device
Terminated
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an ext...
Apr 16, 2021
· Device
Terminated
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Steril...
Nov 11, 2020
· Device
Terminated
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intend...
Aug 25, 2020
· Device
Terminated
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage...
Aug 25, 2020
· Device
Terminated
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intend...
Aug 25, 2020
· Device
Terminated
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated fo...
Jan 10, 2020
· Device
Terminated
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated fo...
Jan 10, 2020
· Device
Terminated
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6...
Jan 10, 2020
· Device
Terminated
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for...
Jan 10, 2020
· Device
Terminated
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588
The el...
Apr 18, 2019
· Device
Terminated
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 80...
Oct 17, 2018
· Device
Terminated
Terumo Advanced Perfusion System 1 Electronic Patient
Gas System, Catalog#: 801188
Sep 13, 2018
· Device
Terminated
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Ca...
Aug 28, 2018
· Device
Terminated
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Ca...
Aug 28, 2018
· Device
Terminated
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT
Monitor with two Blood Parameter modules a...
Jun 26, 2018
· Device
Terminated
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883
Product Usage:
The CDI System 500 provides c...
Jun 26, 2018
· Device
Terminated
Terumo HX2 Temperature Management System, Catalog No. 809810
The Terumo HX2 Temperature Management System is...
Apr 18, 2018
· Device
Terminated
Sarns TCM, Catalog No. 15747
The Sarns TCM is indicated for controlling and monitoring patient temperature...
Apr 18, 2018
· Device
Terminated
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014
The Sarns TCM is in...
Apr 18, 2018
· Device
Terminated
Flowmeter Module (accessory to Terumo Advanced
Perfusion System 1).
Provides the interface between the flow s...
Jan 19, 2018
· Device
Terminated
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads
Product Usage:
Level sensor pads are used to atta...
Mar 14, 2017
· Device
Terminated
Terumo Advanced Perfusion System 1-Level Sensor II Pads,
Product Usage:
Ultrasonic couplant used to facilita...
Mar 14, 2017
· Device
Terminated
HX2" Temperature Management Systems;
The Terumo HX2" Temperature Management System provides temperature cont...
Jul 14, 2016
· Device
Terminated
Preamendments device-Sarns Dual Cooler-Heater.
The Sarns Dual Cooler-Heater is a self-contained unit for s...
Jul 14, 2016
· Device
Terminated
Sarns TCM II;
The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature co...
Jul 14, 2016
· Device
Terminated
Sarns TCM;
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water...
Jul 14, 2016
· Device
Terminated
CDI Blood Parameter Monitoring System 500
Cardiopulmonary bypass on-line blood gas monitor
Product Usage:
Th...
Mar 25, 2016
· Device
Terminated
CDI 500 Blood Parameter Monitoring System.
Provides continuous, on-line monitoring of the extracorporeal parti...
Sep 9, 2015
· Device
Terminated
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for...
May 28, 2015
· Device
Terminated
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System 1 is indicated for...
May 28, 2015
· Device
Terminated
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that d...
Feb 13, 2015
· Device
Terminated
Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with...
Jul 23, 2014
· Device
Terminated
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector
Product Usage:
The Aortic Cannula is indic...
Jul 23, 2014
· Device
Terminated
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector
Product Usage:
Th...
Jul 23, 2014
· Device
Terminated
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8"...
Jul 23, 2014
· Device
Terminated
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or conne...
Jul 23, 2014
· Device
Terminated
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4"...
Jul 23, 2014
· Device
Terminated
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector
Product Usage:
The Aortic Cannula is indicate...
Jul 23, 2014
· Device
Terminated
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without...
Jul 23, 2014
· Device
Terminated
Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare
Product Usage:
The Aortic Cannula i...
Jul 23, 2014
· Device
Terminated
Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and...
Jul 23, 2014
· Device
Terminated
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer...
Jul 23, 2014
· Device
Terminated
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating,
Product Usage:
The Ao...
Jul 23, 2014
· Device
Terminated
CPB Catheter Kit
Product Usage:
Venous Return Cannula is indicated for venous drainage during cardiopulmonary...
Jul 23, 2014
· Device
Terminated