Edwards PediaSat Oximetry Catheter Kit — Class II medical device recall Z-2278-2021
Terminated recall by Edwards Lifesciences, LLC, reported 2021-08-18, distributed in AZ, CA, FL, IN, MD, MI, NJ, NY…. There is a potential for internal leaks within catheters.
| Recall number | Z-2278-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2021-07-09 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2024-01-29 |
| Distributed | AZ, CA, FL, IN, MD, MI, NJ, NY, OH, PA, TX, WA |
| Countries outside the US | AE, AT, BE, BH, BR, CA, CH, CO, CR, DE, ES, FR, GR, IL, IN, IT, JP, MX, NL, PL, PT, TN, TW |
| Quantity | 70 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00690103197563 |
| Lot numbers | 63522902, 63608320 |
| Model numbers | XT3515KTP |
Product
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
Reason for recall
There is a potential for internal leaks within catheters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2278-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.