Pipeline TM Flex Embolization Device with Shield Technology TM PED2-250-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000448684), received between Jan 22, 2026 and Mar 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM LOCATED AT A RIGHT-SIDED ANTERIOR BIFURCATION OF THE MIDDLE CEREBRAL ARTERY, POSITIONED ON THE SIDE OF THE VESSEL, WITH THE APEX POINTING DOWNWARD. THE MAXIMUM ANEURYSM DIAMETER MEASURED 2.2 MM; WITH A NECK DIAMETER OF 2.1 MM. THE LANDING ZONE ARTERY SIZE MEASURED 2.23 MM DISTALLY AND 2.4 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT A FLOW DIVERTER STENT IMPLANTATION WAS PERFORMED FOR A MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM. A PHENOM 27 MICROCATHETER WAS USED, AND A PED2-250-12 FLOW DIVERTER STENT WAS SELECTED. A 5F NAVIEN WAS USED AND A GUIDEWIRE WAS USED TO ADVANCE THE PHENOM 27 MICROCATHETER TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PLAN WAS TO DEPLOY THE STENT ANTERIOR TO M1 BIFURCATION OF THE MIDDLE CEREBRAL ARTERY, OPENING THE STENT IN THE INFERIOR BRANCH, THEN RETRACTING IT TO THE M1 BIFURCATION TO SERVE AS THE DISTAL ANCHORING POINT. AFTER OPENING THE STENT PACKAGING AND HYDRATING IT WITH TIROFIBAN, THE STENT WAS DELIVERED TO THE TARGET SITE. D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562860 ↗
• MalfunctionJan 22, 2026Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FISHMOUTH OPENING DURING DEPLOYMENT, DEFORMATION, AND RESISTANCE WAS DETERMINED TO BE DUE TO TORTUOUS ACCESS, RESULTING IN EXCESSIVE RESISTANCE DURING THE DELIVERY PROCESS AND STENT DEFORMATION. IT WAS CLARIFIED THAT THE RESISTANCE WAS ENCOUNTERED IN THE MID AND DISTAL SECTIONS OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE INCLUDED DEVICE RETRIEVED TWICE, MICROCATHETER AND INTERMEDIATE CATHETER USED FOR INCREASING AND DECREASING TENSION DEPLOYMENT, BUT STILL UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149773 ↗

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-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-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-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