Terumo Cardiovascular Systems Corp
FDA Regulatory Profile
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 45
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0949-2022 | Class II | Cardiovascular Procedure Kit catalog # 76645 & 73806 | February 3, 2022 |
| Z-1314-2018 | Class II | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial | December 18, 2017 |
| Z-2550-2018 | Class II | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extr | May 12, 2017 |
| Z-2706-2016 | Class II | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing | July 25, 2016 |
| Z-2791-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardio | August 24, 2015 |
| Z-2789-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiova | August 24, 2015 |
| Z-2786-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedur | August 24, 2015 |
| Z-2790-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiova | August 24, 2015 |
| Z-2788-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo | August 24, 2015 |
| Z-2792-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardio | August 24, 2015 |
| Z-2787-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Pro | August 24, 2015 |
| Z-1828-2015 | Class II | Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorpo | May 6, 2015 |
| Z-1465-2014 | Class II | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 | March 28, 2014 |
| Z-0157-2015 | Class II | Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 | March 1, 2011 |
| Z-0161-2015 | Class II | Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replace | March 1, 2011 |
| Z-0158-2015 | Class II | Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardiople | March 1, 2011 |
| Z-0160-2015 | Class II | Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product | March 1, 2011 |
| Z-0156-2015 | Class II | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, | March 1, 2011 |
| Z-0159-2015 | Class II | Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code b | March 1, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservo | December 2, 2015 |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | July 25, 2014 |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | February 20, 2014 |
| K132451 | SARNS SOFT-FLOW AORTIC CANNULA | February 18, 2014 |
| K133151 | SARNS HIGH FLOW AORTIC ARCH CANNULA | February 3, 2014 |
| K130333 | CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR | March 13, 2013 |
| K130359 | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OX | March 13, 2013 |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | November 20, 2012 |
| K113214 | TLINK DATA MANAGEMENT SYSTEM (DMS) | February 7, 2012 |
| K112587 | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | December 19, 2011 |
| K112229 | SARN CENTRIFUGAL PUMP | December 9, 2011 |
| K092789 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | May 12, 2010 |
| K092644 | TERUMO PRESSURE ISOLATOR | December 10, 2009 |
| K083747 | TERUMO PALL AL3X ARTERIAL FILTER | August 20, 2009 |
| K090698 | CAPIOX BUBBLE TRAP WITH X-COATING | June 8, 2009 |
| K083834 | TERUMO PALL AL6X ARTERIAL FILTER | April 17, 2009 |
| K090878 | MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) | April 3, 2009 |
| K082321 | TERUMO ROCSAFE HYBRID PERFUSION SYSTEM | February 13, 2009 |
| K083194 | VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 | January 16, 2009 |
| K083301 | X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE | December 18, 2008 |