Edwards PediaSat Oximetry Catheter Set Recall: Potential Internal Leaks
Edwards Lifesciences recalls PediaSat Oximetry Catheter Sets with potential internal leaks. Affected units have specific model and lot numbers. Contact for return instructions.
Lower-risk recall
There is a potential for internal leaks within catheters.
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Sets that may have internal leaks. This could lead to complications if used in medical procedures. Affected units have specific model and lot numbers. Read more at govinfonow.com/recall/62222-edwards-pediasat-oximetry-catheter-set-recall-potential-internal-leaks.
Source Summary by GovInfoNow · govinfonow.com/recall/62222-edwards-pediasat-oximetry-catheter-set-recall-potential-internal-leaks · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2283-2021
Cite this page
“Edwards PediaSat Oximetry Catheter Set Recall: Potential Internal Leaks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62222-edwards-pediasat-oximetry-catheter-set-recall-potential-internal-leaks. Based on FDA recall #Z-2283-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2021%22&limit=1).
Why it’s dangerous
Internal leaks in the catheter could cause fluid to escape during medical procedures. This might lead to complications like infection or inaccurate readings if the device is used improperly.
Who’s affected
Parents or caregivers of infants using this catheter set for medical monitoring. Infants with specific medical conditions requiring this device are at higher risk.
How to tell if you have this one
Check for the model number XT3515SJ, exterior diameter 5.5F, and usable length 15 cm. The lot numbers 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, or 63091148 are affected.
- Brand
Edwards Lifesciences- Product
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2278-2021 | 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 Only, Sterile EO, UDI: (01)00690103197563; LOT NUMBERS: 63522902 AND 63608320 | 70 UNITS |
| Z-2279-2021 | 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; LOT NUMBERS: 62685549, 62728569, 62889136, 62903838, 63256058, 62728569, 62889136, 62903838, 62939833, 62452820, 62661574, 62420335, 62889136, 63256058, 62452820, 62661574, 62685549, 62728569, 62420335, 62420335, 62452820, 62420335, 62452820, 62661574, 62889136, 62903838, 63600994, 63608318, 63608323, 62661574, 62420335, 62661574, 62903838 | 200 UNITS |
| Z-2280-2021 | 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 DISTRIBUTED WITHIN THE US; LOT NUMBERS: 62374649, 62489899, 62505763, 62544662, 62728572, 62889053, 63045884, 63080087, 63105621, 63176482, 63256056, 63266249, 63350873, 63374025 | 218 UNITS |
| Z-2281-2021 | 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; Lot numbers: 62685542, 62685542, 63316354, 62685542, 62704123, 62685542, 62685542, 62667413, 62685542, 62704123, 62685542, 63608316, 62685542, 62704123, 62685542, 62685542, 62704123, 62685542, 62685542 | 178 units |
| Z-2282-2021 | 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; Lot Numbers: 62889103, 62939785, 62954623, 63435579, 63439594 | 50 units |
| Z-2283-2021 | 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 DISTRIBUTED WITHIN THE US; Lot Numbers: 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148 | 152 units |
What to do — step by step
Check Product Details
Look for the model number XT3515SJ, exterior diameter 5.5F, and usable length 15 cm on the catheter set.
Contact Manufacturer
Reach out to Edwards Lifesciences for specific return or replacement instructions.
Where it went and when
Where it was distributed
Distributed in 12 states, and outside the U.S.
FDA distribution: “US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2283-2021 (July 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2283-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.