Cook Inc.: Medical Device Recall in 2019 - (Recall #: Z-0416-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 3, 2019

Date Posted: November 27, 2019

Recall Number: Z-0416-2020

Event ID: 84108

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.

Status: Terminated

Product Quantity: 400

Code Information:

Lot Number 8361746

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.

Voluntary or Mandated:

Voluntary: Firm initiated