# Class II recall Z-3326-2026: Micro Therapeutics,  Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3326-2026 |
| Recalling firm | Micro Therapeutics,  Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | 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 fr |
| Reason | 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. |
| Quantity | 2 |
| Distribution | U.S. Nationwide distribution in the states of GA and TX. |
| Recall initiated | 2026-06-25 |
| Reported | 2026-10-07 |
| Firm location | Irvine, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3326-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.