Z-2773-2026Class II

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12

Name: Z-2773-2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
Creator: Micro Therapeutics, Inc.
Published: 2026-06-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-06-08 / Open, Classified / root cause: labeling and UDI

FDA source

Micro Therapeutics, Inc. began a recall of Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12 on 2026-06-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2773-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-22
Recalling firm: Medtronic, Inc.
Product: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
Product code: OUT Intracranial Aneurysm Flow Diverter
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.
Root cause tag: labeling and UDI
FDA 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 [email protected]. 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 in commerce: 13 units
Distribution: US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Product codes and lots: UDI: 00763000448806/ Lot: D062612, D112860

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2773-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2773-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22
Z-2774-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code OUT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)