Catheter, Oximeter, Fiber-Optic
FDA adverse event reports and recall history for catheter, oximeter, fiber-optic (product code DQE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,061
- Deaths
- 24
- Injuries
- 122
- Malfunctions
- 896
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
- 2020-07-10TerminatedUnder Investigation by firm
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Sterile catheter kit packaging compromised.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
Inability for the guidewire to pass through the needles included with the catheter kits.
- TerminatedProcess control
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
There is a potential for internal leaks within catheters.
- TerminatedProcess control
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
There is a potential for internal leaks within catheters.
Monitor catheter, oximeter, fiber-optic automatically
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