Pipeline Flex Embolization Device
Micro Therapeutics recalls Pipeline Flex Embolization Devices due to incorrect labeling of implant sizes.
Check the label on your device packaging to confirm the labeled size matches the actual implant size. If the label and implant size do not match, stop using the device and contact Micro Therapeutics for return and replacement instructions.
Why it was recalled
Micro Therapeutics is recalling Pipeline Flex Embolization Devices with Shield Technology due to incorrect labeling. 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. This mismatch may lead to improper treatment of intracranial aneurysms.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x
| Product | Recall # | UDI-DI |
|---|---|---|
| 20 mm 027 REF PED2-300-20 | Z-2774-2026 | 00763000448844 |
| 12 mm 027 REF PED2-300-12 | Z-2773-2026 | 00763000448806 |
| 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter | – | 00763000448844 |
| 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter | – | 00763000448806 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Labeling Error recalls
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification