PIPELINE PED-325-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536015067), received between Jan 5, 2021 and Aug 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• InjuryAug 9, 2021Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EMBOLIZATION DEVICE WAS IMPLANTED INTO THE LEFT PARACLINOID WITH FEW ISSUES. POST-PROCEDURE THERE WERE NO INITIAL ISSUES, BUT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AT 8:30 AM ON (B)(6) 2021. THE PATIENT COULD NOT COORDINATE THE THUMB AND PINKY, AND THEY WERE DIAGNOSED WITH A STROKE. THE PATIENT ALSO EXPERIENCED A SEIZURE AT 6:40 PM AND EXPERIENCED MEMORY ISSUES. THE PATIENT RETURNED HOME WITH IMPROVEMENT, BUT THEN HAD MULTIPLE RECURRENT STROKES. THE PATIENT WAS ADMITTED TO THE ICU WITH SPEECH AND WALKING DIFFICULTIES. THE PHYSICIAN GAVE 20 MG/DAY OF DEXAMETHASONE, AND THE VITALS WERE NORMAL. THE ICU NEUROLOGIST SAID THE STENT WAS LEACHING METAL INTO THE BRAIN, BUT ALSO SAID THEY WERE NOT SURE WHAT MATERIAL WOULD BE LEACHING BECAUSE THERE WERE SEVEN MATERIALS IN THE STENT. HOWEVER THE PHYSICIAN STATED THEY HAD NEVER HEARD OF A STENT LEACHING METAL, AND DECLARED THE OTHER PHYSICIAN WAS WRONG. THE PATIENT WAS DISCHARGED FROM THE ICA AND THE STEROIDS WERE REDUCED TO 18 MG/DAY WITH A PLAN TO TAPER TO 6 MG/DAY. THE PATIENT EXPERIENCED SUBSEQUENT PSYCHOSIS AND MEMORY-LOSS. CONCOMITANT MEDICAL PLAVIX, ASPIRIN, KEPPRA, DEXAMETHASONE, TY

  Patient problems: Convulsion/Seizure; Dyskinesia; Dysphasia; Emotional Changes; Ischemia; Memory Loss/Impairment; Nausea; Paresis; Syncope/Fainting; Unspecified Nervous System Problem

  MAUDE report 12294910 ↗
• MalfunctionJan 5, 2021Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DELIVERY WIRE FRACTURED JUST PROXIMAL TO THE RESHEATHING PAD. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE DISTAL ICA. THE MAX DIAMETER WAS 10 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED. THE LANDING ZONE WAS 3 MM DISTAL AND 3 MM PROXIMAL. IT WAS REPORTED THAT THE PHENOM 27 WAS ADVANCED THROUGH THE PIPELINE AFTER SUCCESSFUL DEPLOYMENT OF THE PIPELINE DEVICE AND UPON RETRIEVAL OF THE DELIVERY WIRE. WHILE ATTEMPTING TO CAPTURE THE DELIVERY SYSTEM AND PTFE SLEEVES, THE DELIVERY WIRE FRACTURED JUST PROXIMAL TO THE RESHEATHING PAD. THE DOCTOR FELT THIS HAPPEN, REMOVED THE PHENOM 027, AND WAS ABLE TO RETRIEVE THE DELIVERY WIRE AND FRACTURED DISTAL SEGMENT AS IT GOT LODGED IN THE PHENOM 027. ALL PARTS WERE SUCCESSFULLY REMOVED, AND THE PIPELINE WAS SUCCESSFULLY DEPLOYED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BENCHMARK SHEATH, SOFIA GUIDE CATHETER, AND PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11119364 ↗

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-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-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