Edwards Lifesciences recalls Fogarty Thru-Lumen Embolectomy Catheters with REF 12TLW805F35 due to potential slow balloon deflation (over 15 seconds) during use.
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters with specific reference number 12TLW805F35 because they may deflate slower than normal, taking longer than 15 seconds. This could lead to complications during medical procedures if not addressed promptly.
The catheter's balloon may take longer than 15 seconds to deflate, which can cause blockages or complications during medical procedures. This delay could interfere with the catheter's intended function in removing blood clots.
Healthcare professionals using the catheter for embolectomy procedures are most at risk. Patients receiving this device during medical treatment may also be affected.
Check for the reference number 12TLW805F35 on the catheter packaging or label. The catheter also has a unique identifier (UDI-DI: 00690103043532) and lot number 64936927.
Look for the reference number 12TLW805F35 on the catheter or packaging.
The catheter may experience slower than normal balloon deflation (greater than 15 seconds), which could lead to complications during medical procedures.
Check for the reference number 12TLW805F35 on the catheter or packaging, and the unique identifier (UDI-DI: 00690103043532) and lot number 64936927.
The recall does not specify a remedy, so contact Edwards Lifesciences directly for guidance.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0238-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0238-2024 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.
