CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report
Guardia Access Nano Embryo Transfer Catheter is use recalled by Cook
Cook is recalling Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the. The recall was initiated on 3 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0415-2020
- FDA event ID
- 84108
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Oct 2019
- FDA classified
- 16 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Oct 2019 | Recall initiated by company | |
| 16 Nov 2019 | Classified by FDA | +44 days |
| 27 Nov 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Where it was distributed
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.
Questions about this recall
Is Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the recalled?
Yes. Cook recalled Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the on 3 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0415-2020.
Why was it 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.
Which lots are affected?
Lot Number 9502915
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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