PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000283872), received between Feb 13, 2023 and Jul 3, 2025 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

12 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT'S BLOOD VESSELS WERE MODERATELY TORTUOUS. WHEN THE SURGEON USED PHENOM27 TO DEPLOY PED2 -250-18, THE TIP END COULD NOT BE OPENED AND APPEARED TO BE TWISTED. AFTER REPEATED ATTEMPTS, IT STILL COULD NOT BE OPENED. DURING THE OPERATION, AFTER THREE ATTEMPTS OF RETRIEVING AND DEPLOYMENT, IT STILL COULD NOT BE RELEASED. SAFETY WAS THE PRIORITY, SO A NEW P ED2-250-18 WAS REOPENED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED C3 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2.5MM NECK DIAMETER. LANDING ZONE: DISTAL: 3MM AND PROXIMAL: 3MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394865 ↗
• MalfunctionSep 13, 2024Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DISLODGED DURING DELIVERY AND REMAINS IN THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 6.5 MM AND A 6 MM NECK DIAMETER. LANDING ZONE: DISTAL: 2.2 MM AND PROXIMAL: 2.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL MET THE STANDARD. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A MIDDLE CEREBRAL ARTERY ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING ANEURYSM DENSE MESH TREATMENT. M1 PROXIMAL ANEURYSM IN THE BRAIN, THE STENT WAS DEPLOYED NORMALLY AFTER IT WAS IN PLACE. WHEN IT REACHED THE PROXIMAL END OF THE STENT, IT WAS FOUND THAT THE STENT WAS DISLODGED. IT COULD NOT BE MANIPULATED AND ONLY THE MICROCATHETER COULD BE WITHDRAWN. AFTER THE STENT POPPED OUT, THE PROXIMAL END OF THE TUMOR NECK WAS NOT COMPLETELY COVERED AND HAD TO BE COVERED WITH A NEW STENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT WAS OFF-LABEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURT

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 20214767 ↗
• DeathFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE, RIST CATHETER, AND TWO PHENOM CATHETERS HAD VESSEL DISSECTION. AFTER DEPLOYMENT OF THE PIPELINE AN ARTERIAL DISSECTION WAS OBSERVED AT A POINT PROXIMAL THE DEVICE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE CATHETERS WERE FLUSHED AS PER IFU. THE PIPELINE WAS BEING USED FOR AN INDICATION THAT WAS NOT APPROVED. IT WAS USED TO TREAT AN ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE DEVICE WAS PLACED ON THE RIGHT SIDE FROM THE ACA -A2 SEGMENT TO THE ACA -A1 SEGMENT. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE ACOM RIGHT SIDE. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS 1.9MM AND THE PROXIMAL LANDING ZONE WAS 2.2MM. VESSEL MODERATE. THE ACCESS VESSEL WAS THE RIGHT RADIAL. POST ANGIO SHOWED PROPER DEVICE PLACEMENT AND AN ARTERIAL DISSECTION AT A LOWER POINT IN THE VESSEL. SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. ICP MONITORING AND CONTROL. (B)(6) 2023 (REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPIRED. THE PATIENT HAD EL

  Patient problems: Vascular Dissection

  MAUDE report 16368617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-0307-2017 · Oct 5, 2016 · Terminated
  Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
• Z-0309-2017 · Oct 5, 2016 · Terminated
  Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
• Z-0308-2017 · Oct 5, 2016 · Terminated
  Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
• Z-0120-2016 · Sep 4, 2015 · Terminated
  -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
• Z-1453-2014 · Apr 1, 2014 · Terminated
  Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
• Z-2045-2013 · Jul 19, 2013 · Terminated
  Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-neck