# FDA recall Z-0416-2020

> **Cook Inc.** · Class II · device recall initiated 2019-10-03.

## Product

Guardia Access Embryo Transfer Catheter is used 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

- **Recall number:** Z-0416-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2020

## Citation

> AI Analytics. FDA recall Z-0416-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0416-2020. Source: US FDA. Licensed CC0.

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