Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20

FDA device recall Z-2774-2026 · posted 2026-07-22 · Open, Classified

Recall details

Recalling firm

Micro Therapeutics, Inc.

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.

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.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

OUT

Quantity affected

6 units

Distribution

US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.

Date initiated

2026-06-08

Date posted

2026-07-22

Location

Irvine, CA