PIPELINE PED-400-18 (UDI 00847536015906)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536015906), received between Jul 6, 2020 and Aug 19, 2021 — classified as 4 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 18, 2026.

Recalls naming this device

1. Jul 13, 2021Class IOpen, 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.

• MalfunctionAug 19, 2021Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT THE PIPELINE WAS DIFFICULT TO OPEN AND THE PUSHWIRE WAS NOTED TO BE SEPARATED AT THE PROXIMAL MARKER AFTER RESISTANCE OCCURRED IN THE PHENOM CATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICE WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHENOM CATHETER WAS IN PLACE AND THE PIPELINE WAS DELIVERED. THE TAIL END OF THE STENT WAS DIFFICULT TO OPEN BUT AFTER REPEATED ATTEMPTS, IT DID FINALLY OPEN. THE PHENOM WAS PUSHED FORWARD AND THE WIRE WAS RECOVERED BUT THE PROXIMAL MARKER WAS STUCK AT THE PHENOM TIP. AFTER PULLING BACK, THE PUSHWIRE WAS DISCONNECTED AT THE PROXIMAL MARKER AND THE DISTAL PART OF THE PROXIMAL MARKER REMAINED IN THE PATIENT'S BODY. ATTEMPTS WERE MADE TO COLLECT THE MARKER WITH A SOLITAIRE AB (SAB) WITHOUT SUCCESS SO THE SAB WAS DEPLOYED TO PREVENT MIGRATION OF THE DETACHED MARKER AND THE PROCEDURE WAS COMPLETE. THERE WERE N

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12343696 ↗
• MalfunctionNov 13, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10840616 ↗
• MalfunctionNov 4, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE EMBOLIZATION DEVICE (PED) THAT FAILED TO OPEN. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT OPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 3.4MM AND THE PROXIMAL LANDING ZONE WAS 3.7MM. PATIENT VESSEL TORTUOSITY WAS NORMAL. DUAL ANTI-PLATELET TREATMENT (DAPT) WAS ADMINISTERED. PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT THE PED WAS DELIVERED AND STARTED TO DEPLOY BUT THE TIP WOULD NOT OPEN. THE PED WAS ADJUSTED REPEATEDLY BUT IT STILL FAILED TO OPEN. THE SURGEON WITHDREW THE PED FROM THE PATIENT'S BODY AND REPLACED WITH A NEW PED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE HAD BEEN PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10787990 ↗
• MalfunctionJul 6, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO RESISTANCE WITH THE PIPELINE. THE DEVICE WAS REMOVED DUE TO A TWIST, AND ANOTHER ONE WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10236554 ↗

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-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-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-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