FDA (Devices) recall action 85069
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.
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
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.
Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part in the patient.
Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.