PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000283988), received between Mar 17, 2023 and Mar 4, 2026 — classified as 2 injuries.

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.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD THREE PIPELINE VANTAGE STENTS IMPLANTED TO TREAT A 2.8MM UNRUPTURED SACCULAR BASILAR ARTERY ANEURYSM 5 DAYS PRIOR. NO DEVICE MALFUNCTION WAS REPORTED ASSOCIATED WITH THIS EVENT. PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT AROUND 2000, THE PATIENT PRESENTED WITH DYSARTHRIA AND WEAKNESS IN ALL 4 EXTREMITIES. BY THE TIME NEUROLOGY HAD ASSESSED, THE PATIENT'S SYMPTOMS HAD ALMOST RESOLVED EXCEPT FOR SLIGHT DYSARTHRIA AND HAND PARESTHESIA. THE NEXT MORNING AT 0700, THE NEUROLOGICAL EXAM WAS NORMAL. HOWEVER, AROUND 0900, THE PATIENT AGAIN EXPERIENCED RIGHT UPPER EXTREMITY (RUE) WEAKNESS WITH ANARTHRIA AS WELL AS TREMORS IN LEFT UPPER EXTREMITY (LUE) AND JAW. BY 0930, THE PATIENT ALSO HAD MODERATE DYSARTHRIA WITHOUT APHASIA - COMPREHENSION AND NAMING WERE NORMAL. TREMORS DID NOT APPEAR CLONIC IN NATURE AND STOPPED WHEN HOLDING PATIENT'S HAND; SEIZURE SEEMED UNLIKELY. REPEAT COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WITH NO OBSERVATION OF STROKE OR HEMORRHAGE. BASED ON THE AVAILABLE INFORMATION THE CARE TEAM CONSIDERED THE PATIENT'S FLUCTUATING NEUROLOGICAL SYMPTOMS

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; Nervous System Injury; Obstruction/Occlusion; Paresis; Shaking/Tremors

  MAUDE report 24514137 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A PREVIOUSLY RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS COILED AND HAD A NECK REMNANT THAT HAD GROWN AND REQUIRED TREATMENT, AS WELL AS A POSTERIOR WALL COMPONENT THAT WAS UNPROTECTED BY PRIOR COILS. TH PHYSICIAN DECIDED THAT FLOW DIVERSION WAS MOST ADEQUATE TREATMENT FOR THIS CASE. HIS PLAN WAS TO PLACE THE PIPELINE DISTALLY IN IPSILATERAL (RIGHT) A2 INTO RIGHT A1. ACCESSING THE A2 WAS DIFFICULT, REQUIRING MULTIPLE ATTEMPTS WITH MULTIPLE TYPES OF WIRES. ONCE THE A2 WAS ACCESSED WITH THE WIRE, PHENOM27 WAS ADVANCED PAST THE TARGET TO BEGIN PIPELINE PLACEMENT. MEASUREMENTS WERE OBTAINED AND PED2-300-16 WAS CHOSEN BY THE PHYSICIAN TO BE OPTIMAL SIZE. THE DEVICE WAS LOADED INTO THE PHENOM27 AND DEPLOYED NORMALLY. FOLLOW UP IMAGING DISPLAYED ADEQUATE PLACEMENT AND PATENCY OF THE DEVICE. DURING RECOVERY OVERNIGHT THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE. 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). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMM

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16565552 ↗

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-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-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-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