EDWARDS OXIMETRY CENTRAL VENOUS CATHETER X3820STRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103197587), received between Jan 7, 2025 and Jan 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE OXIMETRY CENTRAL VENOUS CATHETER, DURING USE. THERE WAS LEAKAGE FROM THE OPTICAL MODULE CONNECTOR OF THE CATHETER. THIS RESULTED IN MEDICATION LOSS OF POTASSIUM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096653 ↗
• MalfunctionJan 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE OXIMETRY CENTRAL VENOUS CATHETER, DURING USE. THE CATHETER BODY BECAME KINKED NEAR THE DISTAL END OF THE BACKFORM. AS A RESULT, THE CATECHOLAMINE MEDICATION WAS NOT INFUSED CONTINUOUSLY INTO THE PATIENT. THE MEDICATION BECAME STUCK AT THE KINKED PORTION OF THE CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096650 ↗

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 DISTR
• 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-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 DISTRIBUT
• 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-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-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