—#177200

Product

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

FDA product code: MQF — Catheter, Assisted Reproduction
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K983594
Affected lot / code info: Lot Number 8361746

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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.

Timeline

Recall initiated: 2019-10-03
Terminated: 2020-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177200. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.