FDA Medical Device Recalls (openFDA)
Micro Therapeutics, Inc.: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
- Recall number
- Z-2774-2026
- Recalling firm
- Micro Therapeutics, Inc.
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-22
- Terminated
- not on file
- 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 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.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Lot, serial or model codes
- UDI: 00763000448844/ Lot: D062531
- 510(k) numbers
- not on file
- PMA numbers
- ["P100018S026"]
- Product code
- OUT
- Firm FEI
- 1000220862
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28