Ev3 Pipeline Flex Embolization Device with Shield Technology may fracture during implantation, risking unintended separation. Affected lots listed. No increased risk if device already implanted.
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) recalls Pipeline Flex Embolization Devices with Shield Technology due to a risk of fracture during implantation. If the device has already been successfully implanted, there is no increased risk to patients from this issue.
The device delivery system may fracture at the distal section during implantation. This could cause unintended separation where the distal portion remains in the patient. However, if the device has already been successfully implanted, this issue does not pose additional risk.
Medical professionals using the device for neurological endovascular procedures. Patients who have already had the device implanted successfully are not at increased risk.
Check the lot numbers listed in the recall notice: A918616 through A954809. The device is sold outside the U.S. and used for neurological endovascular procedures.
Identify the lot number on your device to see if it matches the affected list (A918616 to A954809).
Yes, if the device has already been successfully implanted, there is no increased risk due to this issue.
The recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
Check the lot number against the list of affected lots provided in the recall notice (A918616 to A954809).
We’ve drafted a message you can send Ev3 Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2020 — Ev3 Neurovascular Ev3 Neurovascular Hello, I own a Ev3 Neurovascular that is covered by recall Z-1528-2020 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.
