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Cook Inc. recalls Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Recalled November 27, 2019 · FDA recall Z-0416-2020 · Cook
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. · FDA Class II
Units
400
Sold at
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.
Description
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.
Product
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →