Cook recalls Guardia Access Nano Embryo Transfer Catheters that may bend, causing difficulty inserting during IVF embryo transfers. Affected units may require repeat procedures or additional IV: 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 its Guardia Access Nano Embryo Transfer Catheters because bent tips can make it hard to insert during IVF embryo transfers. This could lead to longer procedures, repeat transfers, or extra IVF cycles for patients.
The catheter tips can bend during use, making it difficult to insert into the guiding catheter. This may cause longer procedures, repeat embryo transfers, or additional IVF cycles for patients.
Patients undergoing IVF treatments who use the Guardia Access Nano Embryo Transfer Catheter are most at risk. The recall affects specific lot numbers sold for embryo transfers.
Check for the lot number 9502915 on the catheter packaging. The product is used for transferring IVF embryos into the uterine cavity.
Look for lot number 9502915 on the catheter packaging to confirm if it's affected.
The catheter tips may bend, causing difficulty inserting during IVF embryo transfers, which could lead to longer procedures, repeat transfers, or additional IVF cycles.
Check the lot number on the packaging. If it's 9502915, contact Cook for instructions.
The recall describes potential issues like longer procedures or repeat transfers, but no serious injury risk is mentioned.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0415-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0415-2020 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.
