Z-3326-2026

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he...

Name: Z-3326-2026 Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he...
Creator: Micro Therapeutics, Inc.
Published: 2026-06-25
License: https://open.fda.gov/license/

Micro Therapeutics, Inc. / initiated 2026-06-25 / Open, Classified

FDA source

Recall record

Recall number: Z-3326-2026
Status: Open, Classified
Initiated: 2026-06-25
Posted: 2026-09-28
Recalling firm: Micro Therapeutics, Inc.
Product: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires and indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
Product code: OUT Intracranial Aneurysm Flow Diverter
Reason for recall: Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
FDA root cause: Under Investigation by firm
Action: On 06/25/2026, an "URGENT: MEDICAL DEVICE RECALL" letter was sent to customers to inform them that, Medtronic has confirmed a labeling error involving implant diameter in the affected lot. Devices from Lot # D112860 labeled as PED2-300-12 (3.00 mm diameter, 12 mm length) contain 2.50 mm diameter implants instead of the labeled 3.00 mm diameter. Customers are instructed to: 1. Do NOT use any impacted Pipeline Flex Embolization Device with Shield Technology devices listed. Remove and quarantine all unused impacted product units in their inventory. 2. Return the impacted product(s) to Medtronic. Their 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. Review their records to identify any patients who may have been treated with devices from the affected lot and assess whether any follow-up is appropriate. 5. Share this recall communication within their organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for their records and the records of their patients with Pipeline Shield. For questions - contact Medtronic at 1 (800) 633-8766 or (763) 514-4000 (Worldwide) or Email: [email protected]
Quantity in commerce: 2
Distribution: U.S. Nationwide distribution in the states of GA and TX.
Product codes and lots: Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860

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 2026-10-02. View this recall on fda.gov (opens on fda.gov)