EDWARDS OXIMETRY CENTRAL VENOUS CATHETER X3820SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00690103197433), received between Oct 19, 2023 and Mar 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

6 other recalls cover devices cleared under the same FDA submission (K053609, K110167); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Fluid/Blood Leak

  AS REPORTED DURING USE IN A PATIENT THIS OXIMETRY CATHETER HAD LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. FURTHER DETAILS INCLUDING THE NAME OF THE LEAKED SOLUTION WAS UNAVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634846 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED DURING USE IN A PATIENT THIS OXIMETRY CATHETER HAD LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THE LEAKED SOLUTION WAS TRANSPARENT AND COULD BE SALINE, BUT IT WAS UNABLE TO BE CONFIRMED. NO ADDITIONAL TREATMENT WAS REQUIRED DUE TO THIS EVENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881651 ↗
• MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED DURING CARDIAC SURGERY (MITRAL VALVULOPLASTY) FOR AN ADULT PATIENT, THIS OXIMETRY CATHETER HAD LARGE AMOUNT OF BLOOD LEAKAGE IN ADDITION TO CATECHOLAMINE AND PROPOFOL LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THE PATIENT'S BLOOD PRESSURE DROPPED AND VITAL SIGNS BECAME UNSTABLE DUE TO THIS LEAKAGE. VASOPRESSOR WAS ADMINISTERED AND THE PATIENT WAS CHECKED WHETHER HE CONTRACTED INFECTION AS ADDITIONAL TREATMENT. NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT IS A MALE AND IN HIS 60S. THE EXTENSION TUBE OF OPTICAL MODULE CONNECTOR WAS CLAMPED WITH FORCEPS TO PREVENT THE LEAKAGE SINCE LARGE AMOUNT OF LEAKAGE WAS OBSERVED. THE PATIENT CONDITION IS RECOVERED. THE PATIENT WAS TRANSFERRED TO A HOSPITAL WARD FROM THE ICU, AND THERE WAS NO ALLEGATION THAT THE PATIENT WAS TRANSPORTED FROM THE HOSPITAL WARD AFTERWARD. THE DEVICE WILL BE AVAILABLE FOR EVALUATION. NOVEMBER 19TH 2025 UPDATED: THE PATIENT CONDITION IS RECOVERED. THE PATIENT WAS TRANSFERRED TO A HOSPITAL WARD FROM THE ICU, AND THERE WAS NO ALLEGATION THAT THE PATIENT WAS TRANSPORTED FROM THE HOSPITAL WARD AFTERWARD.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23660494 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED AFTER SURGERY AND RETURNING FROM THE ICU DURING USE IN PATIENT THIS OXIMETRY CATHETER HAD MEDICATION LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. NO FURTHER INFORMATION INCLUDING THE NAME OF LEAKED MEDICATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407847 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE OXIMETRY CATHETER, AFTER THE PATIENT HAD BEEN TRANSFERRED TO THE ICU, THE CATHETER WAS FOUND TO HAVE SALINE, UNKNOWN MEDICATION AND A SMALL AMOUNT OF BLOOD LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THE UNKNOWN LEAKED MEDICATION WAS SEROUS. DURING ORTHOPEDIC SURGERY IN THE OPERATION ROOM, THE PATIENT WENT INTO CARDIAC ARREST AND THIS OXIMETRY CATHETER WAS INSERTED TO THE PATIENT ALONG WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT CONDITION IS UNDER TREATMENT. NO CATHETER REPLACEMENT WAS PERFORMED. NO PATIENT INJURY OCCURRED AND NO ADDITIONAL TREATMENT WAS REQUIRED DUE TO THIS LEAKAGE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294027 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE OXIMETRY CATHETER THERE WAS A SMALL AMOUNT OF BLOOD LEAKAGE FROM AROUND THE OPTICAL MODULE CONNECTOR, FOLLOWED BY MEDICATION LEAKAGE. THE CATHETER WAS USED FOR AN ADULT PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23293882 ↗
• MalfunctionApr 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE OXIMETRY CATHETER, MEDICATION LEAKED FROM THE BACKFORM. THE TYPE OF MEDICATION IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919895 ↗
• MalfunctionMar 27, 2025Break; Break

  AS REPORTED, DURING USE IN PATIENT, THE OPTICAL FIBER OF THIS OXIMETRY CABLE WAS EXPOSED FROM THE CATHETER TIP AS THE PATIENT REMOVED THE CATHETER BY THEMSELVES AT ICU. THE CATHETER WAS INSERTED INTO THE PATIENT DURING CARDIAC SURGERY. THE CUSTOMER TRIED TO CHECK IF THERE WAS ANY RESIDUALS IN THE PATIENT'S BODY WITH ECHO, BUT THEY WERE UNABLE TO IDENTIFY IF IT WAS FROM THE CATHETER OR PLAQUE. THE PATIENT IS BEING MONITORED AT ICU WITHOUT ANOTHER OXIMETRY CATHETER BEING INSERTED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714638 ↗
• MalfunctionDec 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING THE X3820SJD CATHETER THAT PROPOFOL INJECTION LEAKED OUT OF THE OPTICAL MODULE CONNECTOR DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839836 ↗
• MalfunctionOct 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THIS X3820SJD DEVICE, BLOOD MIXED WITH MEDICATION LEAKAGE WAS OBSERVED FROM THE PROXIMAL EXTENSION TUBE AFTER A MITRAL VALVE REPLACEMENT (MVR) PROCEDURE. THE SYSTOLIC BLOOD PRESSURE TEMPORARILY DROPPED FROM 100MMHG TO 40MMHG DUE TO MEDICATION LEAKAGE. HOWEVER, THE PATIENT OUTCOME RECOVERED. THE FOLLOWING ADDITIONAL TREATMENTS WERE PERFORMED DUE TO BLOOD AND MEDICATION LEAKAGE: TREATMENT TO INCREASE BLOOD PRESSURE (DETAILS UNKNOWN) AND STARTING AN IV LINE WITH PRE-EXISTING ACCESS CATHETER FOR HEMODIALYSIS. THE CENTRAL VENOUS (CV) CATHETER WAS REMOVED WITHOUT A REPLACEMENT. LEAKED MEDICATIONS WERE CATECHOLAMINE, NORADRENALINE, LANDIOLOL HYDROCHLORIDE AND NICORANDIL DILUTED WITH SALINE AND GLUCOSE. THE AMOUNT OF BLOOD LEAKAGE IS UNKNOWN. THERE WAS NO EXTENSION OF HOSPITALIZATION WAS REQUIRED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 17965952 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053609, K110167. One submission often covers many models, so check the product and lot details in each record.

• Z-2283-2021 · Jul 9, 2021 · Terminated
  Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIB
• Z-2281-2021 · Jul 9, 2021 · Terminated
  Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm),
• Z-2282-2021 · Jul 9, 2021 · Terminated
  Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only,
• Z-2278-2021 · Jul 9, 2021 · Terminated
  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 O
• Z-2279-2021 · Jul 9, 2021 · Terminated
  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 On
• Z-2280-2021 · Jul 9, 2021 · Terminated
  Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED