Micro Therapeutics recalls several Pipeline Flex Embolization Devices (PED) with specific sizes and lot numbers due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Micro Therapeutics is recalling multiple sizes of Pipeline Flex Embolization Devices (PED) because they may have push wire fractures in the delivery system during use. This could lead to a fracture in the spiral cut area of the Hypotube, which might cause complications during medical procedures.
The hazard involves potential push wire fractures in the delivery system during use, which can present as a fracture in the spiral cut area of the Hypotube. This could lead to complications during medical procedures if the device fails as intended.
Medical professionals who use these devices during procedures are likely affected. The risk is primarily for those using the specific recalled models and lot numbers listed in the recall.
Check if your device has a model number starting with PED (e.g., PED-250-10, PED-275-12) and the specific lot numbers listed in the recall. The devices are used in medical procedures and are not consumer products.
Identify the model number (e.g., PED-250-10) and lot numbers from the recall list to confirm if your device is affected.
The recall indicates potential push wire fractures in the delivery system during use, so affected devices should not be used until the recall action is completed.
Check the model number and lot numbers against the list provided in the recall to determine if your device is affected. If it is, contact Micro Therapeutics for further instructions.
The hazard involves potential push wire fractures in the delivery system during use, which could lead to complications during medical procedures if the device fails as intended.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-2402-2021 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-2402-2021 from Micro Therapeutics. 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.
