Recall Z-2774-2026— Micro Therapeutics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Micro Therapeutics, Inc., initiated 2026-06-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter. 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..
- Recalling firm
- Micro Therapeutics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-08
- Firm location
- Irvine, CA, United States
Product description
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.