Edwards Lifesciences recalls Fogarty Arterial Embolectomy Catheters with specific model numbers and lot numbers due to confirmed latex deterioration complaints. Affected units may have increased risk of allergic reactions or other complications.
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Edwards Lifesciences is recalling certain Fogarty Arterial Embolectomy Catheters because they have reported increased latex deterioration. This could lead to allergic reactions or other complications for patients using these catheters during medical procedures.
The catheters are packaged in pouches that have experienced confirmed latex deterioration. This could lead to allergic reactions or other complications for patients during medical procedures, particularly those with latex allergies.
Patients who have received or are scheduled to receive the recalled Fogarty Arterial Embolectomy Catheters with specific model numbers and lot numbers. Healthcare providers using these catheters are also at risk if they have the affected units.
Check the model numbers: 120403FP, 120602FP, 120803FP, 120804FP, 120805FP, 120806FP, 120807FP. Also check the lot numbers listed in the recall notice for affected units.
Look for model numbers 120403FP, 120602FP, 120803FP, 120804FP, 120805FP, 120806FP, or 120807FP on the catheter packaging.
Verify if your catheter's lot number matches the list of affected lot numbers provided in the recall notice.
Edwards Lifesciences is recalling these catheters due to confirmed reports of latex deterioration in the packaging pouches.
The latex deterioration could lead to allergic reactions or other complications for patients during medical procedures.
Check the model numbers and lot numbers against the lists provided 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-0146-2023 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0146-2023 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.
