Agency classClass IIOur severity:High FDA (Devices)·Z-0415-2020·Announced 2019-11-27

Cook Inc. Recalls Guardia Access Nano Embryo Transfer Catheters

Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter because bent tips may prevent insertion into the guiding catheter.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (procedural failure requiring repeat IVF cycles) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter, identified by Lot Number 9502915. The device is used for transferring IVF embryos into the uterine cavity. The recall was initiated because bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter.

The affected products were distributed to Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland. There was no US distribution of these specific units.

Potential adverse events associated with the use of the affected product include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle. No specific instructions for consumers are provided in the source text, but the recall is classified as FDA Class II.

The recalled product

Product: Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Manufacturer: Cook Inc.
Category: Medical Device — Reproductive Health
Hazard: device-malfunction
procedural-failure
Affected units: 202

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 9502915

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 →

Same manufacturer · Cook Inc.

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Same hazard · device malfunction