FDA recall Z-0415-2020

Cook Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-10-03
Report date
2019-11-27
Termination date
2020-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0415-2020