Pipeline TM Flex Embolization Device with Shield Technology TM PED2-450-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000449360), received between Nov 13, 2025 and Aug 31, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521780 ↗
• MalfunctionAug 21, 2026Unintended Ejection; Retraction Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50371242 ↗
• MalfunctionApr 14, 2026Unintended Ejection; Material Separation; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING TREATMENT OF AN INTRACRANIAL ANEURYSM WITH A PIPELINE FLOW-DIVERTER STENT, A TON-BRIDGE MEDICAL ¿SILVER SNAKE¿ INTERMEDIATE CATHETER WAS USED, AND A PHENOM 27 MICROCATHETER WAS SELECTED. DURING THE PROCEDURE, THE DISTAL TIP END OF THE STENT FAILED TO OPEN. MULTIPLE ATTEMPTS AT RESHEATHING AND REDEPLOYMENT WERE PERFORMED, BUT THE STENT STILL COULD NOT BE OPENED. THE SYSTEM WAS THEN REPLACED WITH ANOTHER SET, AFTER WHICH THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE, WHEN THE SYSTEM WAS WITHDRAWN AND THE PUSH ROD WAS PULLED AGAIN, STENT DETACHMENT WAS OBSERVED. 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 AN AMORPHOUS, UNRUPTURED OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.4MM AND A 2.8MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.9MM AND PROXIMAL: 4.5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ANGIOGRAPHIC RESULT POST PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872388 ↗
• MalfunctionMar 20, 2026Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. THE LANDING ZONE WAS 4.2MM DISTALLY AND 4.8MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD STASIS WITHIN THE ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT DELIVERY CATHETER WAS POSITIONED, THE STENT WAS DELIVERED. ONCE THE STENT WAS IN POSITION, DEPLOYMENT WAS INITIATED, BUT THE TIP END OF THE STENT COULD NOT BE OPENED. AFTER REPEATED ATTEMPTS AT RETRIEVAL AND REDEPLOYMENT, FLUOROSCOPY REVEALED FRAYING AT THE TIP END OF THE STENT. THE STENT WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THE PIPELINE WAS NOT POSITIONED IN A BEND AND LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647816 ↗
• MalfunctionNov 13, 2025Unintended Ejection; Activation Failure; Unintended Ejection; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO OPEN AND PREMATURE OPENING WAS NOT DETERMINED. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. NO DEVICE ISSUES WITH THE PHENOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543258 ↗

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-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-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-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-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