PIPELINE PED-350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536015364), received between Nov 19, 2019 and Apr 21, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 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.

Recalls naming this device

1. Jul 13, 2021Open, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionApr 21, 2022Packaging Problem; Migration; Packaging Problem; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE PIPELINE OPENED SMOOTHLY. THE DEVICE WAS PULLED BACK TO THE ANCHOR POINT, AND THE MIDDLE AND PROXIMAL OF THE STENT WAS CONTINUED TO BE OPENED SMOOTHLY. AFTER BEING COMPLETELY DEPLOYED, THE ENTIRE STENT SUDDENLY SHIFTED TO THE DISTAL AND MOVED TO THE BIFURCATION OF THE END OF THE INTERNAL CAROTID ARTERY. THE SURGEON SUSPECTED THAT THE STENT WAS NOT THE 350-18 SIZE AS INDICATED ON THE PACKAGE. THE STENT WAS DEPLOYED AND COULD NOT BE REMOVED. THE PIPELINE WAS NOT USED OFF LABEL AND THE PIPELINE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. IT WAS UNKNOWN IF A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED FRONTAL AND LATERAL ANGIOGRAPHY SHOWING SMOOTH BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.2MM AND A 2.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168368 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S CONDITION WAS UNCHANGED. THEY REMAINED ALIVE AND UNCONSCIOUS IN THE ICU.

  Patient problems: Obstruction/Occlusion; Stroke/CVA; Unspecified Nervous System Problem

  MAUDE report 11806275 ↗
• InjuryMar 24, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT SURGICAL INTERVENTION WAS PERFORMED TO RESOLVE THE CEREBRAL HEMORRHAGE, AND THE PATIENT HAS RECOVERED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11562775 ↗
• MalfunctionNov 19, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THE DURING THE RELEASE PROCESS, THE TIP OF PIPELINE COULD NOT BE COMPLETELY OPENED. IT WAS RELEASED AGAIN AFTER WITHDRAWN, BUT IT STILL COULD NOT BE OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE PIPELINE WITH A NEW 350-20 PIPELINE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT INTERNAL CAROTID BED SEGMENT. THE ANEURYSM WAS UNRUPTURED, SACCULAR, THE MAX DIAMETER WAS 3.6MM WITH A NECK DIAMETER OF 2.6MM. THE DISTAL LANDING ZONE WAS 3MM AND THE PROXIMAL WAS 3.5MM. THE VESSEL ANATOMY WAS MINIMAL IN TORTUOSITY. NO PATIENT INJURY OCCURRED. THE PIPELINE WAS NOT PLACED IN A BEND, THE PIPELINE OPENED IN A STRAIGHT SECTION AND WAS PLACED IN A RELATIVELY FLAT, WITHOUT LARGE ARC BENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9341866 ↗

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-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-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-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