⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Micro Therapeutics, Inc.: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter

Medical DevicesSource: FDA (device) · Date: 2026-07-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Micro Therapeutics, Inc.
Product
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Recall initiated
2026-06-08
Code info
UDI: 00763000448806/ Lot: D062612
Product quantity
11 units
Voluntary mandated
Voluntary: Firm initiated
City
Irvine
State
CA
Country
United States
Event id
99326
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