← FDA ENFORCEMENT
Z-2773-2026Class II

Micro Therapeutics, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Micro Therapeutics, Inc.
Product type
Device
Status
Ongoing
Report date
2026-07-29
Distribution
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Firm state
CA
Product quantity
11 units
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot info

UDI: 00763000448806/ Lot: D062612

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →