Ev3 Neurovascular recalls certain Pipeline Flex Embolization Devices for neurological endovascular use due to potential fracture at the distal section during implantation, which could cause unintended separation of the device in the patient.
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.
Micro Therapeutics Inc (Ev3 Neurovascular) is recalling specific lots of their Pipeline Flex Embolization Device for neurological endovascular procedures. The device may fracture during implantation, potentially leaving a piece inside the patient. However, if the device has already been successfully implanted, there is no increased risk.
The device delivery system may fracture at the distal section during implantation, causing unintended separation where the distal portion remains in the patient. This could lead to complications if the device does not fully deploy or if the fracture occurs during the procedure. However, the recall states that if the device has already been successfully implanted, there is no increased risk.
Patients who have undergone neurological endovascular procedures using the recalled Pipeline Flex Embolization Device lots listed in the recall. Those who have already had the device successfully implanted are not at increased risk.
Check the lot numbers listed in the recall: A920066 through A959341. These are specific model numbers for the Pipeline Flex Embolization Device used in neurological endovascular procedures.
Identify the lot number on your device, which is listed in the recall as a series of numbers (e.g., A920066).
No, the recall states that if the device has already been successfully implanted, there is no increased risk to patients.
Check the lot number on your device to see if it is in the list of recalled lots. If it is, contact Ev3 Neurovascular for further instructions.
Look for the lot number on your device, which should be one of the numbers listed in the recall (e.g., A920066 through A959341).
We’ve drafted a message you can send Ev3 Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1527-2020 — Ev3 Neurovascular Ev3 Neurovascular Hello, I own a Ev3 Neurovascular that is covered by recall Z-1527-2020 from Ev3 Neurovascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
