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.

51–75 of 204

HighFDA (Devices)·Z-1687-2015·2015-06-03
Terumo Advanced Perfusion System 1 Recalled for Power Loss Risk
Terumo is recalling 1,713 Advanced Perfusion System 1 units worldwide due to a risk of losing system power during critical medical procedures.
Product
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualif
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1688-2015·2015-06-03
Terumo Advanced Perfusion System 1 Base Recalled for Power Loss
Terumo is recalling 1,713 Advanced Perfusion System 1 bases worldwide to address power loss issues. The recall involves design changes and switch protectors.
Product
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualif
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1116-2015·2015-02-25
Terumo HX2 Temperature Management System Recalled for Valve Malfunction
Terumo is recalling 103 HX2 Temperature Management Systems because a malfunctioning mixing valve can cause loss of cooling or heating capability during surgery.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2096-2014·2014-07-30
Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and infe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2100-2014·2014-07-30
Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2014·2014-07-30
Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate
Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2014·2014-07-30
Terumo Recalls Sarns D4 Aortic Arch Cannulae Due to Particulate
Terumo CVS is recalling Sarns D4 Aortic Arch Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2014·2014-07-30
Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2095-2014·2014-07-30
Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate
Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2105-2014·2014-07-30
Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2104-2014·2014-07-30
Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate
Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2106-2014·2014-07-30
Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate
Terumo CVS is recalling 125 CPB Catheter Kits because in-process inspections found loose fiber particulate exceeding specifications.
Product
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2102-2014·2014-07-30
Terumo Dual-stage Venous Return Cannulae Recalled for Loose Fiber Particulate
Terumo CVS is recalling specific lots of venous return cannulae used in heart surgery due to loose fiber particulate found during inspection.
Product
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior ven
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2097-2014·2014-07-30
Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Malleable Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2103-2014·2014-07-30
Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate
Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.
Product
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2101-2014·2014-07-30
Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2028-2014·2014-07-23
Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks
Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
Product
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2030-2014·2014-07-23
Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks
Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.
Product
Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2029-2014·2014-07-23
Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks
Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
Product
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2019-2014·2014-07-16
Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy in specific instructions.
Product
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2018-2014·2014-07-16
Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy.
Product
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1634-2014·2014-05-28
Terumo Recalls CDI Blood Parameter Monitoring System for Inaccurate Readings
Terumo is recalling one CDI Blood Parameter Monitoring System unit in Iowa due to potential inaccuracies in blood gas and hemoglobin measurements.
Product
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1224-2014·2014-03-26
Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare 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 during cardiopulmonary bypass s
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1222-2014·2014-03-26
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, 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 atri
Category
Medical Device
Distribution
15 states
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