Cook Inc. Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Brand
Cook Inc.
Lot Codes / Batch Numbers
Lot Number 8361746
Products Sold
Lot Number 8361746
Cook Inc. is recalling Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity due to Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An Urgent Field Safety Notice letter dated 10/3/19 was sent to customers. The letter instructs customers to identify affected devices, quarantine the devices, return them, and complete the enclosed Customer Response Form. Where product is indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Response form. Returned Product should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected products where applicable.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026