Device product
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Z-0416-2020
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
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.