FDA (Devices) recall action 84108
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter because bent tips may prevent insertion into the guiding catheter.