Edwards Lifesciences recalls specific Fogarty Biliary Balloon Probes due to latex deterioration complaints. Affected models include 410235FP, 410405FP, and 410236FP with listed lot numbers. Consumers should check their product details.
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Edwards Lifesciences is recalling certain Fogarty Biliary Balloon Probes because of reported latex deterioration in the packaging. This could lead to potential issues during medical procedures if the latex degrades.
The latex in the packaging for these medical devices has been reported to deteriorate, which could potentially cause issues during procedures. This deterioration might affect the device's integrity and safety during medical use.
Healthcare professionals using these specific models for procedures are most at risk. Patients receiving these devices may also be affected if the latex deteriorates during use.
Check for model numbers 410235FP, 410405FP, or 410236FP. Also look for specific lot numbers listed in the recall notice. These products were sold with certain UDI-DI codes and lot numbers.
Identify your model number and lot numbers to see if they match the recalled items listed in the notice.
Edwards Lifesciences is recalling these Fogarty Biliary Balloon Probes due to confirmed complaints about latex deterioration in the packaging.
The affected models are 410235FP, 410405FP, and 410236FP with specific lot numbers listed in the recall notice.
The recall does not require immediate discontinuation; however, you should check if your product is affected and follow the steps to verify.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0147-2023 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0147-2023 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.
