Data / Medical devices / United States / Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation: FDA-registered device maker in Ann Arbor, MI, United States, 25 510(k) clearances
Terumo Cardiovascular Systems Corporation is registered with the FDA (registration 1828100) in Ann Arbor, MI, United States. It lists 14 device types. The FDA files 25 510(k) clearances under its listings, the newest dated April 25, 2024. 146 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1828100
- Address
- 6200 Jackson Road, Ann Arbor, MI, United States, 48103
- Owner or operator
- Terumo Cardiovascular Systems Corp. (10039199)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- December 16, 2011
- Registered through
- 2026
- Brand names listed
- ADVANCED PERFUSION SYSTEM 1, Advanced Perfusion System 1, Blade, CDI (TM) SYSTEM 100 MONITORING SYSTEM, CDI BLOOD PARAMETER MONITORING SYSTEM 500, CDI Blood Parameter Monitoring System 550, CDI OneView Monitoring System, CPB Accessory and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 25, 2024 | K234065 | CDI OneView Monitoring System | DRY | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| April 18, 2023 | K221895 | Terumo Advanced Perfusion System 1 | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| November 2, 2018 | K182110 | CDI Blood Parameter Monitoring System 550 | DRY | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| August 17, 2017 | K172220 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| June 7, 2017 | K163531 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| November 17, 2016 | K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | DWB | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| December 16, 2015 | K153376 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| August 27, 2015 | K151349 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| July 25, 2014 | K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | DRY | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| February 20, 2014 | K131041 | ADVANCED PERFUSION SYSTEM 1 | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| September 27, 2013 | K131618 | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST | DWB | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| November 20, 2012 | K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | DRY | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| March 20, 2003 | K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH | DTQ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| June 4, 1996 | K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | DSJ | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| April 19, 1996 | K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | DWB | Substantially Equivalent | 3M Health Care, Ltd. | accessdata.fda.gov |
| April 19, 1996 | K953901 | SARNS 800 ROLLER PUMP | DWB | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| November 17, 1995 | K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM | DWA | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| May 24, 1994 | K940651 | SARNS ULTRASONIC AIR SENSOR | KRL | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| February 24, 1994 | K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK | GFA | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| July 8, 1992 | K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM | DTQ | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| November 5, 1990 | K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM | DTY | Substantially Equivalent | 3M Health Care, Ltd. | accessdata.fda.gov |
| July 13, 1990 | K902198 | SARNS DELPHIN BASE ADAPTER WITH BATTERY | KFM | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| November 3, 1988 | K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) | DWC | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| October 13, 1988 | K882758 | CENTRIFUGAL PUMP SYSTEM LX/DX VERSION | KFM | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
| June 11, 1984 | K841402 | TEMPERATURE CONTROL & MONITOR | DWC | Substantially Equivalent | Sams, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 146.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 28, 2025 | 96858 | Class II | Ongoing | CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit | 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 | accessdata.fda.gov |
| March 3, 2025 | 96331 | Class II | Ongoing | Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 | 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. | accessdata.fda.gov |
| February 20, 2024 | 94083 | Class II | Ongoing | 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 74873 75065 75157 75195 | 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 | accessdata.fda.gov |
| June 8, 2021 | 88350 | Class II | Terminated | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 | 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 | accessdata.fda.gov |
| April 16, 2021 | 87834 | Class II | Terminated | 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. | 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. | accessdata.fda.gov |
| November 11, 2020 | 86779 | Class II | Terminated | (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 Reservoi | Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) | accessdata.fda.gov |
| August 25, 2020 | 86338 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| January 10, 2020 | 84663 | Class II | Terminated | 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, | 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 l | accessdata.fda.gov |
| April 18, 2019 | 82630 | Class II | Terminated | 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 input t | The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. | accessdata.fda.gov |
| October 17, 2018 | 82878 | Class II | Terminated | Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. | 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. | accessdata.fda.gov |
| September 13, 2018 | 81070 | Class II | Terminated | Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 | The service manual was not updated at the time of the release of software version 1.30. | accessdata.fda.gov |
| August 28, 2018 | 80957 | Class II | Terminated | Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763 | 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. | accessdata.fda.gov |
| June 26, 2018 | 80530 | Class II | Terminated | 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, potassiu | 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. | accessdata.fda.gov |
| March 16, 2018 | 79652 | Class II | Terminated | 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. | Update to cooler-heater cleaning instructions. | accessdata.fda.gov |
| January 19, 2018 | 79624 | Class II | Terminated | Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system. | 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). | accessdata.fda.gov |
| February 20, 2017 | 76458 | Class II | Terminated | Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir. | Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. | accessdata.fda.gov |
| June 8, 2016 | 74389 | Class II | Terminated | HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia s | Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. | accessdata.fda.gov |
| March 14, 2016 | 73533 | Class II | Terminated | CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and ca | Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on t | accessdata.fda.gov |
| August 7, 2015 | 71937 | Class II | Terminated | CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and tem | Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. | accessdata.fda.gov |
| May 1, 2015 | 67989 | Class II | Terminated | 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, a | Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protecto | accessdata.fda.gov |
| February 6, 2015 | 70492 | Class II | Terminated | 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. | Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals. | accessdata.fda.gov |
| June 17, 2014 | 68244 | Class II | Terminated | Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS) | An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. | accessdata.fda.gov |
| May 23, 2014 | 68404 | Class II | Terminated | 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 cardio | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | accessdata.fda.gov |
| May 9, 2014 | 68240 | Class II | Terminated | CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535) | There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipp | accessdata.fda.gov |
| March 3, 2014 | 67598 | Class II | Terminated | 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 sing | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | accessdata.fda.gov |
| October 23, 2013 | 66670 | Class II | Terminated | 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***Manufactu | Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled. | accessdata.fda.gov |
| October 23, 2013 | 66624 | Class II | Terminated | 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 | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and Sarns" Venous Return Cannulae. | accessdata.fda.gov |
| July 26, 2013 | 65381 | Class II | Terminated | 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 | Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires servic | accessdata.fda.gov |
| July 26, 2013 | 65380 | Class II | Terminated | 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 b | TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started | accessdata.fda.gov |
| July 26, 2013 | 65354 | Class II | Terminated | 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, | The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operato | accessdata.fda.gov |
| May 30, 2013 | 64530 | Class II | Terminated | 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 controll | Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail. | accessdata.fda.gov |
| February 27, 2013 | 60480 | Class II | Terminated | 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 | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from th | accessdata.fda.gov |
| January 7, 2013 | 64007 | Class II | Terminated | Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns&a | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. | accessdata.fda.gov |
| November 21, 2012 | 63407 | Class II | Terminated | 24 Fr 8mm Sft Flow Str Wire W/L The Sarns 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 presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this | accessdata.fda.gov |
| November 14, 2012 | 63543 | Class II | Terminated | 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, a | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would | accessdata.fda.gov |
| October 16, 2012 | 63344 | Class II | Terminated | HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. | Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. | accessdata.fda.gov |
| September 25, 2012 | 63079 | Class II | Terminated | Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexp | accessdata.fda.gov |
| September 25, 2012 | 62733 | Class II | Terminated | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the | accessdata.fda.gov |
| September 25, 2012 | 62315 | Class II | Terminated | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine p | accessdata.fda.gov |
| September 24, 2012 | 62059 | Class II | Terminated | Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass. | accessdata.fda.gov |
| September 20, 2012 | 62322 | Class II | Terminated | Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perf | Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper compon | accessdata.fda.gov |
| September 10, 2012 | 62313 | Class II | Terminated | Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardi | Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tu | accessdata.fda.gov |
| July 26, 2012 | 62684 | Class II | Terminated | Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass | accessdata.fda.gov |
| July 26, 2012 | 62444 | Class II | Terminated | System 1 base 100/120V 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 | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application | accessdata.fda.gov |
| June 25, 2012 | 62373 | Class II | Terminated | System 1 Base 100/120V 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 proce | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to re | accessdata.fda.gov |
| June 25, 2012 | 62367 | Class II | Terminated | System 1 Base 100/120V 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 proce | Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inabil | accessdata.fda.gov |
| June 22, 2012 | 61480 | Class II | Terminated | System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proc | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery deple | accessdata.fda.gov |
| June 22, 2012 | 61242 | Class II | Terminated | System 1 Base 100/120V 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 proce | Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential h | accessdata.fda.gov |
| June 22, 2012 | 61231 | Class II | Terminated | Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion ci | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob. | accessdata.fda.gov |
| June 22, 2012 | 60341 | Class II | Terminated | Central Control Module for System 1: System 1 Base, 100/120V 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 perfu | Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to o | accessdata.fda.gov |
| June 21, 2012 | 61763 | Class II | Terminated | Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. 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 perfus | Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump | accessdata.fda.gov |
| June 21, 2012 | 61753 | Class II | Terminated | System 1 Base, 100/120V. 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 pro | Terumo Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root ca | accessdata.fda.gov |
| June 20, 2012 | 62732 | Class III | Terminated | System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary by | During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units | accessdata.fda.gov |
| June 18, 2012 | 61479 | Class II | Terminated | Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmona | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded f | accessdata.fda.gov |
| May 9, 2012 | 61742 | Class II | Terminated | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypas | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, | accessdata.fda.gov |
| May 9, 2012 | 61731 | Class II | Terminated | Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding pro | accessdata.fda.gov |
| March 21, 2012 | 60774 | Not yet classified | Terminated | Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatu | Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of d | accessdata.fda.gov |
| March 16, 2012 | 59573 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion | Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although there was no indication that the pump jam contributed to the adverse patient outcome. | accessdata.fda.gov |
| February 23, 2012 | 60718 | Not yet classified | Terminated | Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 12" (31 em) long. Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. | accessdata.fda.gov |
| February 3, 2012 | 60152 | Not yet classified | Terminated | CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during cardiopulmonary bypass procedures. | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. | accessdata.fda.gov |
| January 13, 2012 | 60463 | Not yet classified | Terminated | Roller Pump, 4 Inch Diameter 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 | Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1. | accessdata.fda.gov |
| December 7, 2011 | 60479 | Not yet classified | Terminated | CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's o | Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device. | accessdata.fda.gov |
| December 6, 2011 | 60151 | Not yet classified | Terminated | CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented: Terumo CVS began installing a protective shield (plastic grommet) in the s | accessdata.fda.gov |
| November 17, 2011 | 60011 | Not yet classified | Terminated | Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery. | Terumo Cardiovascular Systems has received one report of minute metal shavings leaking from the Sarns Sternal Saw I System at the point where the saw blade is inserted into the saw handpiece. | accessdata.fda.gov |
| November 10, 2011 | 60289 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for ar | Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The fe | accessdata.fda.gov |
| November 8, 2011 | 59581 | Not yet classified | Terminated | The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for art | 1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000. Five(5)of twelve(12) cables from Terumo Japan, which were in product development, were given to a US customer. | accessdata.fda.gov |
| October 21, 2011 | 59479 | Not yet classified | Terminated | Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional per | Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer. | accessdata.fda.gov |
| September 23, 2011 | 59582 | Not yet classified | Terminated | CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Mon | Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored. | accessdata.fda.gov |
| September 13, 2011 | 59912 | Not yet classified | Terminated | Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker. | accessdata.fda.gov |
| August 29, 2011 | 59528 | Not yet classified | Terminated | Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signa | The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume. | accessdata.fda.gov |
| August 12, 2011 | 59455 | Not yet classified | Terminated | Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir. | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. | accessdata.fda.gov |
| June 10, 2011 | 59189 | Not yet classified | Terminated | VirtuoSaph Plus Endoscopic Vessel Harvesting System, REF VSP550, Sterile, Terumo Cardiovascular System Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for | Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited production launch situation. Teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel. | accessdata.fda.gov |
| May 16, 2011 | 58762 | Not yet classified | Terminated | 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arte | Terumo has discovered several instances of adhesive build-up and or skiving of plastic (plastic flash) inside the distal tip of the Terumo Coronary Ostia Cannula. The defect was discovered during in-house inspection after Terumo CVS implemented a new inspection process for the cannula. There have been no reports of the defect in clinical use. | accessdata.fda.gov |
| May 3, 2011 | 58838 | Not yet classified | Terminated | Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. | The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's manufacturing process. | accessdata.fda.gov |
| April 28, 2011 | 58779 | Not yet classified | Terminated | CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need con | Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation. | accessdata.fda.gov |
| April 21, 2011 | 58532 | Not yet classified | Terminated | Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT. | Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected b | accessdata.fda.gov |
| March 31, 2011 | 58547 | Not yet classified | Terminated | System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and car | The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism. | accessdata.fda.gov |
| February 25, 2011 | 58125 | Not yet classified | Terminated | Sarns Flexible Weighted Sucker, Sterile, catalog 804113, Terumo Cardiovascular Systems, Ann Arbor, MI. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. | The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated | accessdata.fda.gov |
| February 14, 2011 | 57969 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blo | Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' | accessdata.fda.gov |
| January 10, 2011 | 57735 | Not yet classified | Terminated | Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI. The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated | The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar cord. The firm investigated and found that the units involved in the complaints were often over 12 months old. The firm believes the units involved in the compl | accessdata.fda.gov |
| December 2, 2010 | 57416 | Not yet classified | Terminated | Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit. | The firm identified that a component within the System 1 ABD and Occluder Modules that may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion circuit. The Occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the ve | accessdata.fda.gov |
| November 2, 2010 | 57241 | Not yet classified | Terminated | Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. The system 8000 is indicated for use in extracorporeal circulation of bloo | The system 8000 roller pumps may fail resulting in a persistent pump stop. | accessdata.fda.gov |
| November 1, 2010 | 60695 | Class II | Terminated | Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. | Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications. | accessdata.fda.gov |
| November 1, 2010 | 57194 | Not yet classified | Terminated | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indi | The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracies. The CDI 101 and CDI 500 system are stand alone systems that are used during ext | accessdata.fda.gov |
| November 1, 2010 | 57189 | Not yet classified | Terminated | Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. | Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate. | accessdata.fda.gov |
| October 20, 2010 | 57231 | Not yet classified | Terminated | Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI. The sternal saw blades are indicated for use in medial sternotomoties. The saw blades | The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation. | accessdata.fda.gov |
| October 15, 2010 | 56645 | Not yet classified | Terminated | Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI | Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection.. | accessdata.fda.gov |
| September 10, 2010 | 55911 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. | The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the u | accessdata.fda.gov |
| June 11, 2010 | 55224 | Not yet classified | Terminated | Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature control of two independe | The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode. | accessdata.fda.gov |
| October 2, 2009 | 63225 | Class II | Terminated | Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port | Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch and two inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as descr | accessdata.fda.gov |
| August 12, 2009 | 62321 | Class II | Terminated | Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and car | Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Sinc | accessdata.fda.gov |
| July 6, 2009 | 53577 | Not yet classified | Terminated | Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures | The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss. | accessdata.fda.gov |
| January 12, 2009 | 44848 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and | The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use. | accessdata.fda.gov |
| November 7, 2008 | 50554 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extrac | The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing. | accessdata.fda.gov |
| October 16, 2008 | 50227 | Not yet classified | Terminated | Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion | The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it. | accessdata.fda.gov |
| July 18, 2008 | 46312 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusio | The pumps may fail to power up or experience unplanned pump stops. | accessdata.fda.gov |
| July 18, 2008 | 44852 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. | Local pump controls including start/stop button, select button and manual button may not function. | accessdata.fda.gov |
| July 18, 2008 | 44851 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. | The pumps may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use. | accessdata.fda.gov |
| July 18, 2008 | 44839 | Not yet classified | Terminated | Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. | Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk. | accessdata.fda.gov |
| May 23, 2008 | 49604 | Not yet classified | Terminated | Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann | The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition. | accessdata.fda.gov |
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Updated June 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.