Z-0416-2020Class II

Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity

Name: Z-0416-2020 Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity
Creator: Cook Inc.
Published: 2019-10-03
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-10-03 / Terminated

FDA source

Cook Inc. began a recall of Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity on 2019-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0416-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-03
Posted: 2019-11-16
Terminated: 2020-05-13
Recalling firm: Cook Incorporated
Product: Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Product code: MQF Catheter, Assisted Reproduction
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.
FDA root cause: Under Investigation by firm
Action: An Urgent Field Safety Notice letter dated 10/3/19 was sent to customers. The letter instructs customers to identify affected devices, quarantine the devices, return them, and complete the enclosed Customer Response Form. Where product is indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Response form. Returned Product should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected products where applicable.
Quantity in commerce: 400
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.
Product codes and lots: Lot Number 8361746

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0415-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-16
Z-0416-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-16

Product code MQF

K983594Class IIEmbryo Transfer Catheters/setsCook Ob/Gyn / cleared 1998-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)