Class II U.S. Food and Drug Administration

Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology REF recall: Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm

Recall published 18 days ago

Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

The hazard: Lead or heavy metal content

The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

What the notice says: Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-3326-2026
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Micro Therapeutics, Inc.
Product type
Medical devices
Units affected
2
Distribution
Nationwide
Sold at
Giant
Made in
United States
Lot / code info
Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
UPC codes
00763000448806

Products covered by this recall

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires and indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000448806

Model or item number

On the rating label, the box or the instruction sheet.

  • PED2-300-12 UDI-DI
  • GTIN

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Micro Therapeutics, Inc. — The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.
  3. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.
  4. Follow the remedy on this page — lead recalls almost always carry a full refund.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Micro Therapeutics, Inc. — 9775 Toledo Way, Irvine, CA, 92618-1811

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Micro Therapeutics, Inc. medical devices recalled?

Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter. Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000448806; model number PED2-300-12 UDI-DI, GTIN. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide, including at Giant.

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