Guardia Access Nano Embryo Transfer Catheter is use for transferring… — Class II medical device recall Z-0415-2020
Terminated recall by Cook Inc., reported 2019-11-27. Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guid
| Recall number | Z-0415-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-10-03 |
| Classified | 2019-11-16 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-05-13 |
| Countries outside the US | BE, CH, DE, DK, ES, IT, NL, NO, PL, SI |
| Quantity | 202 |
| Lot numbers | 9502915 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0415-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.