Micro Therapeutics recall: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code…
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code… because of a labeling error – 2. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on June 25, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code… |
| Brand | Micro Therapeutics |
| Company | Micro Therapeutics, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | June 25, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 2 |
| Recall ID | 99689 |
Recalled products
- 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.
- FDA recall number
- Z-3326-2026
- Codes, lots and dates
- Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
- Quantity
- 2
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99689
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Irvine, CA, United States
Why it was recalled
The problem: a labeling error.
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S. Nationwide distribution in the states of GA and TX.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99689, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Micro Therapeutics Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code… recalled?
Yes. Micro Therapeutics, Inc. recalled it on June 25, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a labeling error. The reason given: 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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.