Micro Therapeutics Pipeline Flex Embolization Device recalled for incorrect labeling
Micro Therapeutics embolization devices have incorrect labeling: units labeled as 3.0 mm x 20 mm actually contain 12 mm implants, and units labeled as 3.0 mm x 12 mm actually contain 20 mm implants. This mismatch could lead to implantation of the wrong device size. Six units were distributed across multiple states.
From the FDA notice · Read the official notice ↗
What to do
- If you received or used a Pipeline Flex device from lot D062531, contact Micro Therapeutics or your healthcare provider immediately.
- Do not use any affected devices until you confirm the actual implant size with the manufacturer or your medical team.
- Report any adverse events to the FDA MedWatch program.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 6 units
- Illnesses reported
- None reported
- Manufactured in
- 9775 Toledo Way, N/A, Irvine, CA, United States
- Classification
- Class II
- Recall number
- Z-2774-2026
In the FDA's words
- Description
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter 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. UDI: 00763000448844/ Lot: D062531 Distribution: US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA. Affected quantity: 6 units
- 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.
2 products in this recall
The agency lists each product separately. Check every one you might have.
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverterZ-2773-2026 · 11 units
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter (this page)Z-2774-2026 · 6 units