Edwards Lifesciences recalls PediaSat Oximetry Catheter Sets with potential internal leaks. Affected units have specific model and lot numbers. Consumers should contact Edwards for details.
There is a potential for internal leaks within catheters.
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Sets that may have internal leaks. This could lead to complications if the catheter leaks during medical use. Affected units have specific model and lot numbers.
Internal leaks in the catheter could cause medical complications if the device is used improperly. The leak might affect the accuracy of oxygen monitoring in patients.
Patients using the PediaSat Oximetry Catheter Set for medical monitoring are most at risk. The recall applies to specific model and lot numbers sold outside the US.
Check for the model number XT358SP and lot numbers listed in the recall notice. The catheter has an exterior diameter of 5.5F (1.83 mm) and usable length of 9 cm.
Reach out to Edwards Lifesciences for specific instructions on how to verify if your catheter is affected and what to do next.
No, the product is not distributed within the US.
The affected model is XT358SP with specific lot numbers listed in the recall notice.
Check for the model number XT358SP and lot numbers 62685542, 62685542, 63316354, etc., as listed in the recall notice.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2281-2021 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2281-2021 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
