Pipeline Flex Embolization Device with Shield Technology… recallZ-2773-2026 · Micro Therapeutics, Inc. · initiated Jun 8, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-2773-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Jul 22, 2026
- Recalling firm
- Micro Therapeutics, Inc.
- Quantity
- 13 units
- Product code
- OUT
- FDA submissions
- P100018S026
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Product description
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
Code information (models, lots, serial numbers)
UDI: 00763000448806/ Lot: D062612, D112860
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pipeline TM Flex Embolization Device with Shield Technology TM PED2-300-12Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter2 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 99326).
- Z-2774-2026 · Open, ClassifiedPipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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