The Food and Drug Administration on Tuesday classified Medtronic’s recall of its Pipeline Vantage embolization devices as the most serious type of recall.
The recall removed Pipeline Vantage 027 models from the market, which have been linked to 13 reported injuries and four deaths. The action also updated instructions for Pipeline Vantage 021 models, which have been tied to four reported injuries.
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The devices are used to treat brain aneurysms. Physicians insert them into patients’ blood vessels through a small catheter, guide them to the aneurysm site and then place a small, braided tube to the affected area to cut off blood flow.
Medtronic recalled the devices Jan. 30 after reports of an increased risk of the flexible, braided tube not properly attaching or remaining attached to the blood vessel wall during and after procedures.
The risks are higher in women, particularly those under the age of 45. Using the affected devices could lead to thrombosis, stroke or death, according to the FDA.
For patients who have received the affected devices, the FDA recommends that the treating physician assess whether follow-up imaging or changes to treatment are needed based on their overall health.
