PEDIASAT XT245SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103197488), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF A CATHETER, MODEL X3820SJD, THAT HAD MEDICATION AND SALINE MIXED WITH BLOOD LEAK DURING USE. THE PATIENT WAS AN ADULT, AND THE AMOUNT OF LEAKAGE WAS SMALL. NO BLOOD TRANSFUSION NOR THE PROLONGED HOSPITALIZATION WAS REQUIRED DUE TO THE ISSUE. THE CUSTOMER SUSPECTED THE CATHETER BEING SUTURED/PUNCTURED, BUT THE CATHETER WAS REMOVED WITHOUT ANY ISSUES. AFTER THE REMOVAL OF THE CATHETER, THE CUSTOMER TRIED TO IDENTIFY THE LOCATION OF THE LEAKAGE. ALL LUMENS WERE COVERED AND THE CATHETER WAS ABLE TO BE FLUSHED. LEAKAGE WAS LATER IDENTIFIED AT THE OPTICAL MODULE CONNECTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517150 ↗

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-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-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-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-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-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,