Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverterUDIUDI 00763000448844/Affected lotD062531
What the firm is doing
On June 4, 2026, Medtronic (parent company of Micro Therapeutics) issued a Urgent Medical Device Expansion to affected consignees via visit. Medtronic ask consignees to take the following actions: 1. Do NOT use any impacted Pipeline Shield products. Remove and quarantine all unused impacted product units in your inventory. 2. Return the impacted product(s) to Medtronic. Your Medtronic representative can assist in facilitating the return of product and/or identifying suitable replacement product as necessary. 3. Complete the attached Customer Confirmation Form and email it to neuro.quality@medtronic.com. 4. Please share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. 5. Please maintain a copy of this letter for your records and the records of your patients with Pipeline Shield.
DistributionShow detailsHide
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2774-2026
- FDA device classification · OUTOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Micro Therapeutics, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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