Transducer, Pressure, Catheter Tip
Cardiovascular · 21 CFR 870.2870
Recent MDR events
2,389 adverse event reports on file
- PressureWire¿Jul 28, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02974
- PressureWire¿Jul 28, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02975
- PressureWire¿Jul 27, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02929
- PressureWire¿Jul 27, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02948
- PressureWire¿Jul 27, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02949
- PressureWire¿Jul 27, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02956
- Comet IIJul 21, 2026MalfunctionBoston Scientific Corporation2124215-2026-39190
- PRESSUREWIRE¿Jul 20, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02866
- PRESSUREWIRE¿Jul 20, 2026MalfunctionLightlab Imaging, Inc.2024168-2026-02873
- COMET IIJul 20, 2026InjuryBoston Scientific Corporation2124215-2026-38885
Event type breakdown
Recalls
10 recall events for this product code
- Edward Lifesciences, LlcTerminatedSep 16, 2015
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monito
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
Z-2776-2015 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
Z-0446-2016 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1959-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01)
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1960-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01)
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1961-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1962-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1963-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1964-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1965-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
There is a potential that the pressure tubing may detach from the blood sampling system
Z-1966-2021 · View FDA record ↗
Registered firms
120 firms currently registered for this product code
St. Jude Medical, Cardiology Division, Inc.
Plymouth, MN, US
Becton, Dickinson And Company
Irvine, CA, US
Opsens Inc.
Quebec City, CA
Platinum Focus Group Ltd.
London London, City of, GB
Riverside Machine & Engineering, Inc.
Eau Claire, WI, US
C.r. Bard, Inc.
COVINGTON, GA, US
Teleflex Medical Oem Llc
Plymouth, MN, US
Zurich Medical Inc
Plymouth, MN, US
Supercomal Medical Products, Sdn Bhd
SUNGAI PETANI Kedah, MY
Isomedix Operations, Inc.
Minneapolis, MN, US
Boston Scientific Corporation
Coventry, RI, US
Freudenberg Medical, Llc
Jeffersonville, IN, US
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Volcano Corporation
San Diego, CA, US
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Synergy Health Ast, Srl
Alajuela, CR
Deroyal Industries, Inc.
POWELL, TN, US
Philips Electronics Ltd
Mississauga Ontario, CA
Fenwal International, Inc.
HAINA San Cristobal, DO
510(k) clearances
64 clearances for this product code
- Opsens, Inc.Jan 16, 2026
K251367 · OptoMonitor 3
- Opsens, Inc.Feb 12, 2025
K241418 · OptoMonitor 3
- Acist Medical Systems, Inc.Jul 17, 2024
K233904 · ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- Edwards Lifesciences, LLCDec 22, 2022
K222216 · TruWave Disposable Pressure Transducer
- Opsens, Inc.Nov 24, 2020
K202943 · OptoMonitor 3
- Opsens, Inc.Jun 18, 2020
K193620 · OptoMonitor 3
- Boston Scientific CorporationDec 23, 2019
K193279 · Comet II Pressure Guidewire
- Opsens, Inc.Dec 12, 2019
K192340 · OptoMonitor