Pipeline TM Flex Embolization Device with Shield Technology TM PED2-500-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000449575), received between Dec 5, 2025 and Sep 11, 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.

• MalfunctionSep 11, 2026Activation Failure

  Medtronic received a report of Pipeline failure to open in the middle section. The patient was undergoing surgery for treatment of a saccular, unruptured, tandem aneurysm in the C6 and C7 segments of the internal carotid artery. It had a max diameter of 5 mm and a 4 mm neck diameter. The landing zone was 3.2 mm distally and 5. 1 mm proximally. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (DAPT) was administered. The angiographic result post procedure showed flow-diverting stent implantation for internal carotid artery aneurysm It was reported that during treatment, a Pipeline PED2-500-25 was used. The tip of the stent was successfully opened and positioned in the middle cerebral artery. During continued deployment, when the stent had opened to the midsection, it failed to expand. Multiple attempts to push and manipulate the device were made, but the stent still did not open. Deployment was then continued, and it was also able to open near the terminal segment; however, the midsection still could not open. It was therefore replaced with a PED2-500-20. The Pipeline was not used for an indication that is not approved (off-label). The Pipeline an

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734992 ↗
• MalfunctionAug 26, 2026Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457073 ↗
• MalfunctionApr 24, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE ENCOUNTERED RESISTANCE AND FAILED TO OPEN THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED FLOW DIVERSION THERAPY ANEURYSM LOCATED ON THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 12MM AND A 7MM NECK DIAMETER. THE LANDING ZONE WAS 4.2MM DISTALLY AND 5.1MM PROXIMALLY. ACCESS VESSEL WAS THE FEMORAL ARTERY AND IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED DURING THE PROCEDURE. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT THERE WAS OBVIOUS CONTRAST RETENTION WITHIN THE ANEURYSM, WITH NO VESSEL LOSS. IT WAS REPORTED THAT THE SPECIFIC SITUATION WAS THAT THE ANEURYSM WAS RELATIVELY LARGE AND THE VESSEL WAS HIGHLY TORTUOUS, SO THE CUSTOMER SPENT A LONG TIME ESTABLISHING ACCESS. AFTER THE MICROCATHETER WAS POSITIONED, IT REACHED TO THE M1-M2 BEND, AND STENT DELIVERY WAS INITIATED. THE INITIALLY SELECTED STENT WAS A PED2-500-20. THE CUSTOMER STARTED STENT DELIVERY, AND REPORTED SIGNIFICANT RESISTANCE DURING DELIVERY. AFTER SUCCESSFUL POSITIONING, STENT DEPLOYMENT WAS STARTED. WITH THE STENT LOCATED IN THE STRAIGHT SEGMENT OF M1, THE CUSTOMER BEGAN WITHDR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982224 ↗
• MalfunctionDec 5, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO RESISTANCE DURING DELIVERY OR POSITIONING OF THE PIPELINE. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728521 ↗

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-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-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-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-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