Recall Z-2774-2026
Micro Therapeutics, Inc. · initiated June 8, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
Codes / lots: UDI: 00763000448844/ Lot: D062531
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.
FDA-determined cause: Labeling Change Control
Action taken
On June 25, 2026, Medtronic (parent company of Micro Therapeutics) issued a Urgent Medical Device Expansion to affected consignees via visit. The revised notification included additional lots of product. The initial notification was issued on June 4, 2026 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.
Details
- Recall number
- Z-2774-2026
- Initiated
- June 8, 2026
- Posted by FDA
- July 22, 2026
- Product code
- OUT – Intracranial Aneurysm Flow Diverter
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Recalling firm
- Micro Therapeutics, Inc., Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2773-2026 Class II | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF…Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and… | 06/08/2026Open, Classified |