PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000284077), received between Dec 9, 2024 and Nov 18, 2025 — classified as 3 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 16, 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.

• MalfunctionNov 18, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLOW DIVERTING STENT WAS DEPLOYED SMOOTHLY, WITH THE TIP RIVETED TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, AND THE PROXIMAL END RIVETED TO THE C6 SEGMENT. WHEN ADVANCING THE PHENOM 27 MICROCATHETER, RETRIEVING THE PTFE CUFF AT THE TIP OF THE PED STENT, THE CUFF REMAINED STUCK ON THE TIP OF THE MICROCATHETER, PREVENTING RETRACTION. AFTER MULTIPLE ATTEMPTS, RETRIEVAL WAS ABANDONED AND THE ENTIRE STENT WAS REMOVED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN INTERNAL CAROTID ARTERY C7 SEGMENT ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 8 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED 5F XINWEI INTERMEDIATE CATHETER, STRYKER MICROCATHETER, PIPELINE 3.25 X 16 MM FLOW DIVERSION STENT. ADDITIONAL INFORMATION WAS RECEIVED. THE ANEURYSM WAS A 4MM, FUSIFORM ANEURYSM IN THE MIDDLE CEREBRAL ARTERY. THE PIPELINE STENT WAS IMPLANTED. THERE WAS NO FRICTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582174 ↗
• MalfunctionAug 27, 2025Material Frayed; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF A PIPELINE FLEX SHIELD STENT WAS FRAYED AND DID NOT OPEN, AND THE DISTAL END OF THE PHENOM 27 MICROCATHETER WAS KINKED. THE PATIENT WAS UNDERGOING FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM OF THE RIGHT INTERNAL CAROTID POSTERIOR COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 4.8 MM AND A 4.3 MM NECK DIAMETER. THE LANDING ZONE ARTERY DIAMETER WAS 2.67 MM DISTALLY AND 3.23 MM PROXIMALLY. FEMORAL ARTERY VASCULAR ACCESS DIAMETER WAS 5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED; HOWEVER, THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS UNCHECKED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NOTED AS NORMAL BLOOD FLOW. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). AFTER THE PHENOM 27 MICROCATHETER WAS IN PLACE, THE STENT WAS POSITIONED AND DEPLOYMENT INITIATED. DURING DEPLOYMENT, IT WAS OBSERVED THAT THE TIP END OF THE STENT APPEARED FRAYED AND COULD NOT ADHERE SMOOTHLY T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908496 ↗
• MalfunctionDec 9, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR CEREBRAL ARTERY WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. THE LANDING ZONE WAS 3.3MM DISTALLY AND 3.0MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD RETENTION IN THE ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT WAS IN PLACE, THE TIP END WAS DEPLOYED, BUT THE TIP END COULD NOT OPEN. IT WAS RETRIEVED AND DEPLOYED AGAIN. AFTER THE TIP END OPENED, IT COULD NOT ADHERE TO THE WALL. IT WAS RETRIEVED AND DEPLOYED AGAIN, BUT STILL COULD NOT ADHERE TO THE WALL. THE TIP END OF THE STENT WAS SUCKING, SO THE STENT AND MICROCATHETER WERE WITHDRAWN FROM THE BODY, AND THE TIP END OF THE STENT WAS PUSHED OUT OF THE BODY. IT WAS FOUND THAT THE TIP END OF THE STENT WAS SUCKING, ROUGH, AND DAMAGED. A NEW STENT WAS USED AND RE-IMPLANTED, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED AS THE ANEURYSM LOCATION WAS NOT WITHIN THE INDICATION RANGE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877209 ↗

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-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-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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• 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-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-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-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