Recall Z-3326-2026 ยท OUT Intracranial Aneurysm Flow Diverter
Micro Therapeutics, Inc.
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-chromiu
| Date | Sep 28, 2026 (initiated Jun 25, 2026) |
| Status | Open, Classified |
| 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 |
| 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 |
| Quantity | 2 |
| Distribution | U.S. Nationwide distribution in the states of GA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.