PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000283926), received between Jul 23, 2025 and Dec 22, 2025 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. UPON EXPOSING APPROXIMATELY 7¿8 MM OF THE STENT¿S TIP AND WAITING FOR ABOUT 10 SECONDS, THE TIP FAILED TO OPEN. THE OPERATOR PROCEEDED TO DEPLOY THE STENT ABOUT 12 MM, BUT THE TIP REMAINED UNOPENED. ATTEMPTS WERE MADE TO RETRIEVE AND REDEPLOY THE STENT, INCLUDING MANEUVERS SUCH AS SHAKING AND PUSH-PULL; HOWEVER, THE TIP STILL DID NOT OPEN. FURTHER ADJUSTMENTS OF PHENOM 27 MICROCATHETER TENSION WERE PERFORMED, BUT THE TIP REMAINED UNOPENED. CONSEQUENTLY, THE STENT WAS REMOVED FROM THE BODY. THE STENT AND MICROCATHETER WERE REPLACED WITH MEDTRONIC PRODUCTS 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, LEFT MIDDLE CEREBRAL ARTERY A NEURYSM WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 2 MM DISTALLY AND 2.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 6 MM. DUAL ANTIPLATELET TRE ATMENT (DAPT) WAS ADM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863493 ↗
• MalfunctionJul 23, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WAS FRICTION OR RESISTANCE DURING DELIVERY OF THE PIPELINE. ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579233 ↗

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-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-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