Terumo Cardiovascular Systems Corp.
Terumo Cardiovascular Systems Corp. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2015, with 19 FDA device recalls on record.
Top product codes for Terumo Cardiovascular Systems Corp.
FDA recalls by Terumo Cardiovascular Systems Corp.
10 most recent of 19- Z-0949-2022 — Cardiovascular Procedure Kit catalog # 76645 & 73806
- Z-1314-2018 — Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.
- Z-2550-2018 — Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
- Z-2706-2016 — Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. US Product Codes: 72021 72358 71180-01 76021 76022 76023 76024 76025 71801-01 71801-01 71801-01 71801-01 71801-01 74163-03 71296-01 74460-01 74460-01 74460-01 73208-03 74382-01 74382-01 74382-01 74916 74916 74916 70089-07 74063-01 74063-01 74460-01 74460-01 74460-01 74460-01 75252-01 74951 75881 74271-01 71085-02 72742 75314 75368 75368 76095 76095 73339-01 73789 74417 72204 72965-03 73644 73645-01 73700 73861 73871 73901-03 75612 75617 75986 76095 73645-01 73645-01 70099-04 75544 75272 75674 75674 73180 73180 73180 75437 75674 75274 73811 73811 74915 71175-03 73738 76117 75129 75642 75642 72596 72596 72596 75179 74980-01 8340TXC-07 8340TXC-07 8340TXC-07 71875-01 74235-01 74476 75059 75547 75547 74235-01 8351TXC-01 73124 73281-01 73282-01 73874 74477 8340TXC-07 76069 76070 76071 76072 74737 73933 73933 73933 73933 73933 73933 71608-04 75413 74959 75472 75472 75449 75923 75923 73729-01 73730-01 74046-
- Z-2788-2015 — Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
- Z-2791-2015 — Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
- Z-2792-2015 — Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
- Z-2787-2015 — Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
- Z-2786-2015 — Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.
- Z-2789-2015 — Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Terumo Cardiovascular Systems Corp.
- K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
- K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K131041 — ADVANCED PERFUSION SYSTEM 1
- K132451 — SARNS SOFT-FLOW AORTIC CANNULA
- K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA
- K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
- K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
- K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS)
- K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
- K092789 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K092644 — TERUMO PRESSURE ISOLATOR
- K083747 — TERUMO PALL AL3X ARTERIAL FILTER
- K083834 — TERUMO PALL AL6X ARTERIAL FILTER
- K090878 — MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
- K082321 — TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
- K083194 — VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
- K083301 — X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
- K080034 — THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
- K080774 — CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
- K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
- K070839 — MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
- K063618 — TENDERFLOW PERIATRIC ARTERIAL CANNULA
- K062597 — TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
- K062381 — CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
- K051997 — CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
- K052205 — CAPIOX AF125X ARTERIAL FILTER
- K040023 — CAPIOX FLEXIBLE VENOUS RESERVOIR
- K032128 — TERUMO AL8X ARTERIAL FILTER WITH X-COATING
- K031891 — VIRTUOSAPH
- K030505 — CAPIOX CARDIOTOMY RESERVOIR
- K022947 — ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
- K023056 — CIRCUIT TUBINGS WITH X-COATING
- K020967 — TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
- K021020 — TERUMO GAS FILTER
- K020998 — SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
- K013578 — PUMP TUBING
- K010443 — CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
- K013526 — CAPIOX RX HARDSHELL RESERVOIR
- K012209 — CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
- K011804 — CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
- K003604 — ADAPTERS WITH X-COATING
- K002238 — CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
Data sourced from openFDA. This site is unofficial and independent of the FDA.