Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks
Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a risk-of-harm product where internal leaks could compromise device function and patient safety. No illnesses or injuries are reported in the source material, and the hazard is described as potential rather than confirmed to have caused actual harm.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Edwards PediaSat Oximetry Catheter Set (REF: XT358KTP) with exterior diameter 5.5F, usable length 8 cm, and three lumens. The affected lot numbers are 62889103, 62939785, 62954623, 63435579, and 63439594. A total of 50 units were distributed.
The recall is being issued due to a potential for internal leaks within the catheters.
The affected products were distributed in the United States (California, Texas, Florida, Arizona, Pennsylvania, Indiana, New York, New Jersey, Michigan, Washington, Maryland, and Ohio) as well as internationally in Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Oman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, and Canada.
The recalled product
- Product
- 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, Sterile EO, UDI: (01)00690103197556
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- internal-leak
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: 62889103
- 62939785
- 62954623
- 63435579
- 63439594
Distribution
Distributed in 12 states:
- AZ
- CA
- FL
- IN
- MD
- MI
- NJ
- NY
- OH
- PA
- TX
- WA
Related recalls
Same category
- SevereThyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination
FDA (Devices) · 2026-07-08
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- HighBoston Scientific CRE Pro Wireguided catheters recalled for packaging
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighCRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
FDA (Devices) · 2026-07-08