Micro Therapeutics recalls EV3 Pipeline Flex Embolization Device with Flex Shield Technology (PED2-250-10 to PED2-500-35) with specific lot numbers due to potential push wire fractures in the delivery system during use.
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 several models of their EV3 Pipeline Flex Embolization Device with Flex Shield Technology. The device may have push wire fractures in the delivery system, which could lead to complications during medical procedures. Affected units have specific lot numbers listed in the recall notice.
The device may experience fractures in the spiral cut area of the Hypotube during use, which could lead to improper function or complications during medical procedures. However, the recall does not indicate immediate injury risks to patients.
Medical professionals who use the EV3 Pipeline Flex Embolization Device with Flex Shield Technology for procedures involving blood vessel embolization. Patients who have received the device during treatment are not directly affected by this recall.
Check the product's model number (PED2-250-10 to PED2-500-35) and lot numbers listed in the recall notice. The specific lot numbers are provided for each model in the recall details.
Identify the model number and lot numbers from the recall notice to determine if your device is affected.
The recall does not indicate immediate safety risks to patients, but affected devices may have potential push wire fractures during use. Medical professionals should check the recall details to confirm if their device is affected.
Check the model number (PED2-250-10 to PED2-500-35) and lot numbers listed in the recall notice. The specific lot numbers are provided for each model in the recall details.
The recall does not require immediate discontinuation of use. Affected devices may have potential push wire fractures, but the hazard is not described as causing serious injury in normal use.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-2403-2021 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-2403-2021 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.
