Device recall
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.
- Recall number
- Z-3326-2026
- Event id
- 99689
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Micro Therapeutics, Inc.
- Report date
- Oct 7, 2026
- Posted
- Sep 28, 2026
- Initiated
- Jun 25, 2026
- Center classification date
- Sep 28, 2026
- Product code
- OUT
- Device type
- Intracranial Aneurysm Flow Diverter
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 2
- Code info
- Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
- Distribution
- U.S. Nationwide distribution in the states of GA and TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States