Catheter, Oximeter, Fiber-optic
Cardiovascular · 21 CFR 870.1230
Recent MDR events
1,067 adverse event reports on file
- ICU MEDICALJul 21, 2026MalfunctionIcu Medical, Inc.25889227
- EDWARDS OXIMETRY CENTRAL VENOUS CATHETERJul 21, 2026InjuryEdwards Lifesciences Pr2015691-2026-17009
- HEMOSPHERE ALTAJul 20, 2026MalfunctionEdwards Lifesciences2015691-2026-16975
- EDWARD LIFESCIENCES SWAN GANZ CCO CATHETERJul 13, 2026MalfunctionEdwards Lifesciences Technology SarlMW5190656
- SMART PRESSURE CONTROLLERJul 8, 2026MalfunctionEdwards Lifesciences2015691-2026-16672
- HEMOSPHEREJul 1, 2026MalfunctionEdwards Lifesciences Irvine2015691-2026-16515
- PRESEP CENTRAL VENOUS OXIMETRY KITJun 29, 2026MalfunctionEdwards Lifesciences Pr2015691-2026-16445
- PRESEP CENTRAL VENOUS OXIMETRY KITJun 29, 2026MalfunctionEdwards Lifesciences Pr2015691-2026-16446
- HEMOSPHERE ALTAJun 17, 2026MalfunctionEdwards Lifesciences2015691-2026-16094
- HEMOSPHEREJun 9, 2026MalfunctionEdwards Lifesciences2015691-2026-15913
Event type breakdown
Recalls
14 recall events for this product code
- Edwards Lifesciences, LLCTerminatedJul 10, 2020
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Sterile catheter kit packaging compromised.
Z-2007-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-1996-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-1997-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-1998-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-1999-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-2000-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-2001-2020 · View FDA record ↗ - ICU Medical, Inc.TerminatedUnknown
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge press
Inability for the guidewire to pass through the needles included with the catheter kits.
Z-2002-2020 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
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.
There is a potential for internal leaks within catheters.
Z-2278-2021 · View FDA record ↗ - Edwards Lifesciences, LLCTerminatedUnknown
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 0.0
There is a potential for internal leaks within catheters.
Z-2279-2021 · View FDA record ↗
Registered firms
99 firms currently registered for this product code
Supercomal Medical Products, Sdn Bhd
SUNGAI PETANI Kedah, MY
Becton, Dickinson And Company
Irvine, CA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
C.r. Bard, Inc.
MADISON, GA, US
Benchmark Electronics, Inc.
WINONA, MN, US
Icu Medical, Inc
Salt Lake City, UT, US
Technical Services For Electronics, Inc.
New Taipei City, TW
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Amphenol Cable And Interconnect Technologies Asia Pacific Ltd.
Tsimshatsui, Kowloon, HK
Maquilas Teta Kawi S.a. De C.v.
NOGALES KM2 EMPALME Sonora, MX
Edwards Lifesciences Technology Sarl
ANASCO, PR, US
Isomedix Operations Inc.
Sandy, UT, US
Icu Medical, Inc.
Lake Forest, IL, US
Draeger Medical Systems, Inc.
ANDOVER, MA, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
510(k) clearances
19 clearances for this product code
- Edwards Lifescience, LLCFeb 20, 2018
K172423 · PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- Edwards Lifesciences, LLCJun 16, 2016
K160645 · PreSep Oligon Oximetry Catheter
- Icu Medical, Inc.Jul 2, 2014
K140129 · PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
- Edwards Lifesciences, LLCFeb 18, 2011
K110167 · PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- Hospira, Inc.Sep 18, 2009
K091268 · HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
- Hospira, Inc.Nov 3, 2006
K062999 · OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
- Hospira, Inc.Oct 5, 2006
K061585 · OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
- Hospira, Inc.Aug 4, 2006
K061450 · HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS