Transducer, Pressure, Catheter Tip
FDA adverse event reports and recall history for transducer, pressure, catheter tip (product code DXO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,365
- Deaths
- 20
- Injuries
- 417
- Malfunctions
- 1,912
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-09-16TerminatedDevice Design
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
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.
- TerminatedUnder Investigation by firm
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.
- TerminatedUnder Investigation by firm
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) 57460691954507
There is a potential that the pressure tubing may detach from the blood sampling system
- TerminatedUnder Investigation by firm
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) 07460691954489
There is a potential that the pressure tubing may detach from the blood sampling system
- TerminatedUnder Investigation by firm
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) 57460691930174 ***Not Marketed within the US
There is a potential that the pressure tubing may detach from the blood sampling system
- TerminatedUnder Investigation by firm
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
- TerminatedUnder Investigation by firm
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
- TerminatedUnder Investigation by firm
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
- TerminatedUnder Investigation by firm
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
- TerminatedUnder Investigation by firm
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
Monitor transducer, pressure, catheter tip automatically
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