Official recall notice
FDA DeviceClass IINotable
FDA Recall: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intra
- Recall date
- 2026-07-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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 description
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.
Affected products
UDI: 00763000448806/ Lot: D062612