PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000284374), received between Feb 18, 2025 and Jan 13, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO OPEN, FRICTION, OR DAMAGE WAS NOT DETERMINED. RESISTANCE WAS REPORTED AT THE DISTAL END OF THE CATHETER, WITH SIGNIFICANT RESISTANCE FELT DURING BOTH STENT ADVANCEMENT AND RETRIEVAL. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE WAS OBSERVED ON THE PIPELINE PUSHWIRES. THE PROXIMAL SECTION OF THE PIPELINES DID NOT OPEN, AND THE DEVICES HAD BEEN PLACED IN A VESSEL BEND WHEN THIS OCCURRED. ADDITIONAL STEPS WERE ATTEMPTED, INCLUDING RETRIEVAL AND RE-DEPLOYMENT; HOWEVER, BECAUSE THE DISTAL END DID NOT FULLY OPEN, THE DEVICES WERE NOT FULLY DEPLOYED, AND NO GUIDEWIRE, CATHETER, OR BALLOON MANIPULATION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053639 ↗
• MalfunctionDec 10, 2025Retraction Problem; Unintended Movement; Activation Failure; Migration; Physical Resistance/Sticking; Retraction Problem; Unintended Movement; Activation Failure; Migration; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE WAS PERFORMED VIA A PERCUTANEOUS RADIAL ARTERY APPROACH. UNDER DSA FLUOROSCOPIC GUIDANCE, THE DELIVERY SYSTEM WAS ADVANCED ALONG THE GUIDEWIRE TO THE TARGET LESION, AND THE DEVICE WAS DELIVERED AND POSITIONED ACCORDING TO THE STANDARD STEPS OUTLINED IN THE PRODUCT¿S INSTRUCTIONS FOR USE. THE CAUSE ID THE DEPLOYMENT FAILURE WAS DETERMINED THAT THE ANGIOGRAPHY REVEALED THAT THE STENT HAD MIGRATED INTO THE ANEURYSM AND COULD NOT BE RETRIEVED. ANOTHER STENT WAS SUBSEQUENTLY PLACED, AND ANGIOGRAPHY SHOWED GOOD STENT APPOSITION AND NORMAL BLOOD FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774415 ↗
• MalfunctionSep 15, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE MET RESISTANCE IN THE MARKSMAN CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, FUSIFORM ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 8.1 MM AND A 5.8 MM NECK DIAMETER. THE LANDING ZONE WAS 8.1 MM DISTALLY AND 4.2 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 6.1 MM DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED STENT ADHESION AND CONTRAST AGENT RETENTION. IT WAS REPORTED THAT AFTER THOROUGH HYDRATION, THE PIPELINE STENT WAS PUSHED TO GO TO THE TARGET POSITION THROUGH THE MICROCATHETER. DUE TO THE SHORT LENGTH OF THE C7 SEGMENT, IT WAS PLANNED TO ANCHOR THE STENT¿S TIP END IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE SURGEON ENCOUNTERED CONSIDERABLE RESISTANCE WHILE PUSHING THE STENT. UPON REACHING THE STRAIGHT SECTION OF M1, THE TIP END OF THE STENT WAS DEPLOYED, DEPLOYING APPROXIMATELY 8 MM AT THE INTENDED SITE, AND THE TIP END OPENED SMOOTHLY. ATTEMPTS WERE MADE TO FURTHER PUSH THE STENT TO INCREASE TENSION, AND THE SURGEON REPOSITIONED BY PULLING BACK. AFTER CONFIRMING THE ANCHORING POSIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052950 ↗
• MalfunctionFeb 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING A PIPELINE EMBOLIZATION DEVICE, THE TIP OF THE STENT COULD NOT BE OPENED. THE ANEURYSM WAS LOCATED AT C5, UNRUPTURED, SACCULAR IN MORPHOLOGY, WITH A MAXIMUM DIAMETER OF 6MM AND A NECK DIAMETER OF 5MM. THE DISTAL LANDING ZONE WAS 4.1 MM AND PROXIMAL LANDING ZONE WAS 4.0 MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DESPITE MULTIPLE ATTEMPTS TO OPEN THE STENT TIP, IT REMAINED CLOSED. ANOTHER STENT WAS USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE INDICATED VASCULAR PATENCY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403314 ↗

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-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-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-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-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