Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Edwards PediaSat Oximetry Catheter Set Recalled by Edwards Lifesciences, LLC Due to There is a potential for internal leaks within...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.
Affected Products
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), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
Quantity: 178 units
Why Was This Recalled?
There is a potential for internal leaks within catheters.
Where Was This Sold?
This product was distributed to 12 states: AZ, CA, FL, IN, MD, MI, NJ, NY, OH, PA, TX, WA
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report