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FDAOctober 3, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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