Recall Z-2773-2026 ยท OUT Intracranial Aneurysm Flow Diverter
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
| Date | Jul 22, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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@m |
| Quantity | 11 units |
| Distribution | US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.