Probe, Blood-Flow, Extravascular
FDA adverse event reports and recall history for probe, blood-flow, extravascular (product code DPT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 387
- Deaths
- 7
- Injuries
- 16
- Malfunctions
- 364
Reports per year
Source: FDA adverse event reports by year received, 2008–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-10-23Open, ClassifiedProcess control
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex Arterial Kit 1/EA, Product Code REF MX7827
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-23Open, ClassifiedProcess control
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
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