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Pipeline Flex Embolization Device with Shield Technology… recallZ-3326-2026 · Micro Therapeutics, Inc. · initiated Jun 25, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Micro Therapeutics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-3326-2026
Status
Open, Classified
Initiated by the company
Jun 25, 2026
Posted by the FDA
Sep 28, 2026
Recalling firm
Micro Therapeutics, Inc.
Quantity
2
Product code
OUT
FDA submissions
P100018S026
Distribution
U.S. Nationwide distribution in the states of GA and TX.

Product description

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.

Code information (models, lots, serial numbers)

Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page