Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.
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 is an FDA Class II medical device recall with a potential hazard (internal leaks) that could affect patient monitoring. No illnesses or injuries have been reported, placing this at High severity consistent with risk-of-harm products where injury has not yet occurred.
Plain-English summary
Edwards Lifesciences, LLC is recalling Edwards PediaSat Oximetry Catheter Kits (REF: XT3515SP). These devices are sterile pediatric catheters for monitoring oxygen saturation in patients. The recall affects 200 units with specific lot numbers.
The catheters are being recalled due to a potential for internal leaks within the catheter. Internal leaks could affect the catheter's ability to monitor oxygen saturation in patients.
The affected catheters were distributed to healthcare facilities in the United States and internationally, including distribution to 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. Within the U.S., distribution included California, Texas, Florida, Arizona, Pennsylvania, Indiana, New York, New Jersey, Michigan, Washington, Maryland, and Ohio.
Patients who received these catheters should contact their healthcare provider to determine if they received an affected product. Healthcare providers should review the recalled lot numbers and take appropriate action to ensure patient safety.
The recalled product
- Product
- 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 Only, Sterile EO, UDI: (01)00690103197532
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 200
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 (13)
- LOT NUMBERS: 62685549
- 62728569
- 62889136
- 62903838
- 63256058
- 62939833
- 62452820
- 62661574
- 62420335
- 62685549
- 63600994
- 63608318
- 63608323
Distribution
Part of a larger recall action
This product is one of 6 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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