FDA Device recall Z-0415-2020
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity by Cook, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0415-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-03 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | n/a |
Product
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
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.
Identifiers
| code_info | Lot Number 9502915 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0415-2020%22
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