Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device

Date: 09/22/2021

Product type: Medical Device

Recalled Product

  • Product Names: Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
  • Models Numbers:
    • Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX
    • Pipeline Flex Embolization Device with Shield Technology: PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX
  • Full Product Codes: See Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology Recall Database Entries
  • Devices Recalled in the United States: 8,825 (Limited only to the Pipeline Flex Embolization Device)
  • Distribution Date: April 18, 2019 to August 13, 2020
  • Date Initiated by Firm: July 13, 2021

US-FDA Link: