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Recall Observatory FDA recall evidence

Device product

Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.

Z-0416-2020

October 03, 2019

Class II

Product summary

Firm
Cook Inc.
Event
Event 84108
Status
Terminated
Classification
Class II
Quantity
400
Official record key
device-enforcement:Z-0416-2020

Official wording

Reason: 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.

Code information: Lot Number 8361746

Distribution pattern: No US distribution. The products were distributed to the following foreign countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.