Class II — Micro Therapeutics, Inc.
| Recalling firm | Micro Therapeutics, Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. |
| Product | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter |
| Quantity | 11 units |
| Distribution | US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA. |
| Initiated | 2026-06-08 |
| Classified | 2026-07-22 |
| Recall number | Z-2773-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Micro Therapeutics, Inc. (Z-2773-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99326/
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