Data / Medical devices / United States / Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation: FDA-registered device maker in Elkton, MD, United States, 30 510(k) clearances
Terumo Cardiovascular Systems Corporation is registered with the FDA (registration 1124841) in Elkton, MD, United States. It lists 17 device types. The FDA files 30 510(k) clearances under its listings, the newest dated November 18, 2021. 18 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1124841
- FEI number
- 3000204839
- Address
- 125 Blue Ball RD, Elkton, MD, United States, 21921
- Owner or operator
- TERUMO CARDIOVASCULAR SYSTEMS CORP. (1828100)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 25, 2002
- Registered through
- 2026
- Brand names listed
- ADAPTERS WITH X-COATING, CAPIOX CARDIOTOMY RESERVOIR, CAPIOX CIRCUIT CONNECTORS, CAPIOX FLEXIBLE VENOUS RESERVOIR, CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR, CAPIOX SP PUMP WITH X-COATING, CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA, CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR 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 |
|---|---|---|---|---|---|---|
| November 18, 2021 | K200091 | Capiox iCP Centrifugal Pump | KFM | 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 |
| June 22, 2018 | K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| April 21, 2016 | K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | GEI | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| December 3, 2015 | K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| December 2, 2015 | K153143 | Capiox Advance Hardshell Reservoir | DTN | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| November 19, 2015 | K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| October 20, 2015 | K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| October 31, 2014 | K140008 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| June 2, 2014 | K140774 | TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| March 13, 2013 | K130359 | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| March 13, 2013 | K130333 | CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| May 12, 2010 | K092789 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | GCJ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| March 5, 2008 | K073474 | CAPIOX CIRCUIT CONNECTORS | DTL | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| April 24, 2007 | K070839 | MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR | DTN | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| August 24, 2006 | K062381 | CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| March 1, 2004 | K040023 | CAPIOX FLEXIBLE VENOUS RESERVOIR | DTN | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| July 29, 2003 | K031891 | VIRTUOSAPH | GCJ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| May 14, 2003 | K030505 | CAPIOX CARDIOTOMY RESERVOIR | DPW | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| November 26, 2002 | K023056 | CIRCUIT TUBINGS WITH X-COATING | DWF | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| September 19, 2002 | K022857 | PUMP TUBING WITH X-COATING | DWE | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| August 15, 2001 | K012209 | CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X | KFM | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| February 7, 2001 | K003604 | ADAPTERS WITH X-COATING | DTL | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| December 21, 2000 | K003371 | PUMP TUBING WITH X-COATING | DWF | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| November 6, 1997 | K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 | DRY | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 15, 1993 | K923982 | OLYMPUS OES LAPAROSCOPY SYSTEM | GCJ | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| September 18, 1992 | K922992 | CONDUCER CARDIOPLEGIA SET SITH MP4 | DWF | Substantially Equivalent | 3M Health Care, Ltd. | accessdata.fda.gov |
| January 15, 1992 | K915265 | CDI(TM) H/S CUVETTE, MODIFICATION | DRY | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 12, 1982 | K820297 | WM. HARVEY OVERPRESSURE SAFETY VALVE | DTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 30, 1981 | K810079 | SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS | KRI | Substantially Equivalent | 3M Health Care, Sarns | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 1, 2023 | 91775 | Class II | Ongoing | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port. | accessdata.fda.gov |
| March 2, 2021 | 87504 | Class II | Terminated | Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the devic | There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. | accessdata.fda.gov |
| June 14, 2019 | 83240 | Class II | Terminated | Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | accessdata.fda.gov |
| December 20, 2018 | 82019 | Class II | Terminated | Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 | Presence of natural rubber latex is not declared in the label | accessdata.fda.gov |
| August 31, 2018 | 81094 | Class II | Terminated | VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing ac | The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU. | accessdata.fda.gov |
| June 27, 2017 | 78546 | Class II | Terminated | TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J | Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. | accessdata.fda.gov |
| December 11, 2015 | 75118 | Class III | Terminated | CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocri | Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display. | accessdata.fda.gov |
| May 27, 2015 | 76386 | Class II | Terminated | The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusio | Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. | accessdata.fda.gov |
| January 5, 2015 | 76346 | Class II | Terminated | Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment | Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken | accessdata.fda.gov |
| August 20, 2014 | 76344 | Class II | Terminated | Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel | Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential | accessdata.fda.gov |
| April 14, 2014 | 68024 | Class II | Terminated | Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures. | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | accessdata.fda.gov |
| December 12, 2013 | 67193 | Class II | Terminated | 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 all | Sterility of medical devices intended for use in surgical procedures may be compromised. | accessdata.fda.gov |
| July 26, 2013 | 65981 | Class II | Terminated | 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 | Medical device used in cardiovascular procedures is defective. | accessdata.fda.gov |
| June 4, 2013 | 67064 | Class II | Terminated | Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line | Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. | accessdata.fda.gov |
| July 21, 2011 | 59454 | Not yet classified | Terminated | CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation | Reservoir blood bag used in cardiovascular procedures may leak. | accessdata.fda.gov |
| June 28, 2010 | 60475 | Not yet classified | Terminated | Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22. 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorpo | Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators. | accessdata.fda.gov |
| June 8, 2010 | 56413 | Not yet classified | Terminated | Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375 | Medical device vent port may be occluded and prevent delivery of priming fluid. | accessdata.fda.gov |
| March 15, 2010 | 56322 | Not yet classified | Terminated | Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 16427 | Medical device component may malfunction and require user intervention during surgical bypass procedures. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- All makers of Reservoir, Blood, Cardiopulmonary Bypass
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Heat-Exchanger, Cardiopulmonary Bypass
Updated April 5, 2023. 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.