Manufacturer

Terumo Cardiovascular Systems Corporation

204 recalls in our database name Terumo Cardiovascular Systems Corporation as the manufacturing or recalling firm.

What the numbers show

Total: 204
Critical: 0
Severe: 20
Most recent: 2025-07-02

Of the 204 recalls from Terumo Cardiovascular Systems Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 204

HighFDA (Devices)·Z-1218-2014·2014-03-26
Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena ca
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1221-2014·2014-03-26
Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1220-2014·2014-03-26
Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-1219-2014·2014-03-26
Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right at
Category
Medical Device
Distribution
15 states
SevereFDA (Devices)·Z-1069-2014·2014-03-05
Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.
Product
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0603-2014·2014-01-08
Terumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve
Terumo is recalling 24,227 Custom Cardiovascular Procedure Kits because the Overpressure Safety Valve used in the arterial line was not cleared for that specific use.
Product
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0336-2014·2013-11-27
Terumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts
Terumo CVS is recalling nine Vascutek Gelsoft vascular grafts because they were incorrectly labeled with the wrong diameter.
Product
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inc
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0196-2014·2013-11-20
Terumo Recalls Sarns Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0195-2014·2013-11-20
Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo is recalling 30 units of Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.
Product
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0193-2014·2013-11-20
Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo CVS is recalling 90 units of Sarns Soft-Flow Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0194-2014·2013-11-20
Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.
Product
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2261-2013·2013-10-02
Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
Product
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2013·2013-08-21
Terumo Advanced Perfusion System 1 Recalled for Incomplete Operator Manual Instructions
Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump behavior during specific alarm conditions.
Product
Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1978-2013·2013-08-21
Terumo Advanced Perfusion System 1 Recall for Pressure Alarm Issue
Terumo is recalling 1,657 Advanced Perfusion System 1 units to update manuals and address a false high-pressure alarm that can stop the pump.
Product
220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1973-2013·2013-08-21
Terumo Advanced Perfusion System 1 Recalled for False Pump Service Error
Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.
Product
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2013·2013-08-21
Terumo Advanced Perfusion System 1 Recall for Incomplete Operator Manual
Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.
Product
Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used b
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1974-2013·2013-08-21
Terumo Advanced Perfusion System 1 Recalled for False Service Pump Error Messages
Terumo is recalling 1,657 Advanced Perfusion System 1 units because user-induced motor movement can trigger a false 'Service Pump' error message, potentially misleading operators.
Product
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1977-2013·2013-08-21
Terumo Advanced Perfusion System 1 Recalled for False Pressure Alarm
Terumo is recalling 1,657 Advanced Perfusion System 1 units because a false high-pressure alarm can stop the pump. The company is updating manuals and issuing labeling addenda.
Product
100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error
Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because a software algorithm inaccuracy was discovered during internal testing.
Product
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error
Terumo is recalling the CDI 500 Blood Parameter Monitoring System because software inaccuracies were found in the algorithm. A software update is being developed to correct the issue.
Product
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, he
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Inaccuracies
Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because software inaccuracies may affect monitoring during cardiopulmonary bypass.
Product
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desire
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1730-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System for Software Error
Terumo is recalling the CDI 500 Blood Parameter Monitoring System due to software algorithm inaccuracies. A software update is being developed to correct the issue.
Product
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hema
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1732-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring Systems
Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.
Product
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperatur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1569-2013·2013-07-03
Terumo Recalls Sarns TCM II Temperature Control Modules Due to Assembly Defect
Terumo is recalling seven Sarns TCM II Temperature Control Modules because internal testing found incorrectly assembled heatsinks that could cause unit failure.
Product
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0802-2013·2013-02-20
Terumo CDI 101 Hematocrit Monitor Recalled for Inaccurate Readings
Terumo is recalling 622 CDI 101 Hematocrit/Oxygen Saturation Monitoring Systems because software errors cause inaccurate readings of blood and oxygen levels.
Product
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Category
Medical Device
Distribution
0 states