Pipeline TM Flex Embolization Device with Shield Technology TM PED2-300-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000448813), received between Apr 10, 2026 and Sep 25, 2026 — 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.

• MalfunctionSep 25, 2026Material Deformation; Activation Failure

  Medtronic received information regarding a Pipeline that failed to open at the distal end and was damaged. The patient was undergoing a procedure for flow diversion treatment of a left middle cerebral artery (MCA) unruptured saccular aneurysm. The aneurysm max diameter was 5.4mm and the neck diameter was 4mm. The distal landing zone was 2mm; the proximal landing zone was 2.6mm. Patient's vessel tortuosity was normal. It was reported that the Pipeline and all accessory devices were prepared as indicated in the instructions for use (IFU). During dep loyment, the Pipeline stent tip failed to open. The Pipeline was resheathed, and deployment was reattempted. When the catheter was retracted to the middle of the Pipeline for deployment but the tip still failed to open. The stent was resheathed and removed. When removed, damage to the tip of the Pipeline stent was observed. The Pipeline was replaced with another of the same model which was delivery and deployed to successfully complete the procedure. The stent showed good wall apposition with stasis in the aneurysm. There was no harm or injury to the patient. Ancillary Devices: 6F long sheath, Navien 5F 125cm intermediate catheter, Phenom

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898283 ↗
• MalfunctionApr 10, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED INTRACRANIAL ANEURYSM LOCATED AT LEFT MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 4 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 2.5 MM DISTALLY AND 3 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE SURGEON SELECTED A PED SHIELD DENSE-MESH STENT. ONCE VASCULAR ACCESS WAS ESTABLISHED, THE STENT WAS ADVANCED TO THE IPSILATERAL M1 SEGMENT. AFTER EXPOSING APPROXIMATELY 7¿8 MM OF THE STENT'S TIP, WAITING FOR ABOUT 10 SECONDS; THE TIP FAILED TO OPEN. IT WAS CONTINUED TO DEPLOY AN ADDITIONAL 12 MM OF THE STENT, YET THE TIP REMAINED UNOPENED. THE SURGEON ATTEMPTED TO RETRIEVE AND THEN RE-DEPLOY IT; DESPITE MANEUVERS SUCH AS GENTLE AGITATION AND PUSHING AND PULLING, THE TIP STILL WOULD NOT OPEN. FURTHER ADJUSTMENTS TO THE TENSION OF THE MICROCATHETER ALSO FAILED TO OPEN IT. CONSEQUENTLY, THE STENT WAS WITHDRAWN FROM THE BODY; IT WAS FOUND THAT THE STENT'S TIP WAS UNABLE TO OPEN. THE STENT WAS THEN REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839165 ↗

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-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-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-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