The Recall Desk
ModerateFDA (Devices)·Z-0416-2020·Announced 2019-11-27

Guardia Access Embryo Transfer Catheter Recall Due to Bent Tips

The FDA is recalling the Guardia Access Embryo Transfer Catheter because bent tips can make insertion difficult, potentially requiring repeat procedures. No injuries have been reported, so the recall is classified as moderate severity.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as moderate because the FDA Class II designation combined with the absence of reported illnesses or injuries places it below the threshold for higher severity. The source explicitly states no illnesses or injuries have been reported, and while the hazard (bent tips) could theoretically cause complications, actual harm has not been documented.

Plain-English summary

The U.S. Food and Drug Administration is recalling the Guardia Access Embryo Transfer Catheter manufactured by Cook Inc. because bent transfer catheter tips may cause difficulty or inability when inserting the catheter into the guiding catheter during IVF procedures. The potential adverse events include increased procedural time, the need for a repeat embryo transfer, or an additional IVF cycle.

The recall applies to Lot Number 8361746 and was distributed to several foreign countries including Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland. No U.S. distribution occurred.

Consumers who have received or are receiving this product should discontinue use immediately and contact their healthcare provider or Cook Inc. for guidance. The manufacturer is advised to investigate and replace affected units. Because no illnesses or injuries have been reported, the severity is assessed as moderate rather than higher.

This recall falls under FDA Class II classification, and since no fatalities or serious injuries have been documented, the severity score remains at 2 (Moderate). The hazard involves a mechanical defect in the catheter tip design that could compromise insertion success, though actual clinical outcomes have not been observed.

The recalled product

Product
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Manufacturer
Cook Inc.
Category
Medical Device — IVF Embryo Transfer Catheter
Hazard
Affected units
400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number 8361746

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · mechanical defect

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