PEDIASAT XT245KTPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103197570), received between Dec 10, 2025 and Dec 10, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 10, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED, AFTER CATHETER PLACEMENT DURING USE IN PATIENT WHEN BLOOD BACKFLOW WAS CHECKED, A PEDIASAT OXIMETRY CATHETER ASPIRATED AIR. IT IS UNCLEAR WHICH LUMEN (DISTAL, MEDIAL, PROXIMAL) ASPIRATED AIR. NO MEDICATION LEAKAGE OCCURRED. AFTER THE CATHETER REMOVAL, THE CUSTOMER PERFORMED A TEST IN THE WATER AND FOUND A HOLE ON THE PATIENT (DISTAL) SIDE OF BACKFORM, AND LEAKAGE WAS OBSERVED FROM THE SAME LOCATION. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770701 ↗

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-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-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-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-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-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-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,