Quick Facts at a Glance
- Recall Date
- June 8, 2026
- Hazard Level
- HIGH
- Brand
- Micro Therapeutics
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Micro Therapeutics
- Model numbers
- UDI: 00763000448844/ Lot: D062531
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 8, 2026
Reported by FDA DEVICE
July 29, 2026
RecallRadar source check
August 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Micro Therapeutics, Inc. or your healthcare provider for instructions. Notification method: Visit
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Full Description
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. 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.. Classification: Class II. Quantity: 6 units. Distribution: US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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