Pipeline TM Flex Embolization Device with Shield Technology TM PED2-475-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000449452), received between Jan 12, 2026 and Sep 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869853 ↗
• MalfunctionApr 15, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT TIP FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED INTERNAL CAROTID ARTERY C7 SEGMENT ANEURYSM. IT HAD A MAX DIAMETER OF 2.5 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE WAS 1.79 MM DISTALLY AND 5.39 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERYWITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. IT WAS REPORTED THAT THE SURGEON SUSPECTED THE ANEURYSM TO BE A BLISTER-LIKE, AND PLANNED TO PERFORM TREATMENT USING COIL EMBOLIZATION ASSISTED BY A DENSE-MESH STENT. THE SURGEON UTILIZED A NON-MEDTRONIC STENT MICROCATHETER TO DEPLOY THE STENT. AFTER POSITIONING THE STENT MICROCATHETER IN THE M2 SEGMENT AND THE ECHELON-14 MICROCATHETER IN PLACE, IT WAS DELIVERED AND EMBOLIZATION OF THE ANEURYSM WAS PERFORMED. A PIPELINE (PED 4.75-16) STENT WAS THEN DELIVERED TO THE STRAIGHT SEGMENT OF M1. WHEN WITHDRAWING THE MICROCATHETER, THE STENT'S TIP WAS EXPOSED APPROXIMATELY 5 MM; UPON ATTEMPTING TO ADVANCE THE DELIVERY ROD¿MOVING IT FORWARD BY ABOUT 15 MM¿THE STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885254 ↗
• MalfunctionMar 24, 2026Activation Failure

  ANY CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN DISTALLY ARE UNKNOWN. ANY CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN IN THE MIDDLE SECTION ARE ALSO UNKNOWN. MULTIPLE ATTEMPTS WERE MADE TO RESHEATH, BUT IT STILL COULD NOT FULLY OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680213 ↗
• MalfunctionJan 20, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE WAS UNDETERMINED. THE PHYSICIAN SUSPECTED ANATOMY AND RECAPTURE CONTRIBUTED TO THE DISTAL PORTION NOT OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123219 ↗
• MalfunctionJan 12, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2) WAS DEPLOYED AT THE LANDING ZONE, HOWEVER, THE DISTAL END WOULDN'T OPEN. THE STENT WAS RECAPTURED AND THE SYSTEM WAS ADVANCED UP MORE DISTALLY INTO THE M1 SEGMENT AND DEPLOYMENT WAS ATTEMPTED AGAIN BUT THE DEVICE WAS STILL NOT OPENING. THE DEVICE LOOKED IRREGULAR UNDER FLUOROSCOPIC IMAGING AND THE PHYSICIAN OPTED TO RESHEATH THE DEVICE AND REMOVE IT FROM THE PATIENT WITH THE MICROCATHETER. ONCE DEVICE WAS REMOVED AND LAID ON THE BACK TABLE, THE DEVICE LOOKED PINCHED ON THE DISTAL END. THE STENT WAS REPLACED WITH A DIFFERENT SIZE PED2 TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.37 MM DISTALLY AND 4.7 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SUCCESSFUL IMPLANT OF THE REPLACEMENT DEVICE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043523 ↗

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-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-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