Cook recalls Guardia Access Embryo Transfer Catheters with bent tips that may cause difficulty inserting during IVF procedures, requiring repeat transfers or additional cycles.
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
Cook is recalling embryo transfer catheters used in IVF procedures because bent tips can cause insertion problems. This may lead to longer procedures, repeat transfers, or additional IVF cycles for patients.
Bent catheter tips can make it difficult to insert the transfer catheter into the guiding catheter. This may cause increased procedural time, requiring a repeat embryo transfer or additional IVF cycles.
Patients undergoing IVF procedures who use the affected catheters. Those with bent tips are at risk of needing repeat transfers or additional IVF cycles.
The affected catheters have a lot number of 8361746. They are used for transferring IVF embryos into the uterine cavity.
Look for lot number 8361746 on the catheter packaging or label.
Bent tips may cause difficulty inserting the catheter into the guiding catheter, potentially requiring repeat embryo transfers or additional IVF cycles.
Check the lot number on the catheter. If it's 8361746, contact Cook for guidance.
The recall describes potential issues with procedure success, not direct injury risks. The hazard does not mention physical harm.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0416-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0416-2020 from Cook. 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.
