Pipeline Flex Embolization Device with Shield Technology — Class II medical device recall Z-2773-2026
Ongoing recall by Micro Therapeutics, Inc., reported 2026-07-29, distributed nationwide. Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devic
| Recall number | Z-2773-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics, Inc., Irvine, CA, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-07-22 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00763000448806 |
| Lot numbers | D062612 |
| Model numbers | PED2-300-12 |
Product
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2773-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.