PIPELINE PED-350-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536015272), received between Jun 24, 2019 and Oct 12, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE THAT WAS THOUGHT TO HAVE SEPARATED. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT OF THE PIPELINE, THE PHYSICIAN FELT THAT THE PUSHWIRE DETACHED FROM THE DEVICE SO IT WAS DECIDED TO RECAPTURE THE PIPELINE AND START OVER. IT WAS NOTED THERE WAS NO FRICTION OR OTHER DIFFICULTY BUT THOUGHT THE PUSHWIRE MAY HAVE BEEN DAMAGED. ANOTHER PIPELINE WAS IMPLANTED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: PHENOM 27 MICROCATHETER ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO PUSHWIRE BREAK OR APPARENT DAMAGE. THE DEVICE SEEMED TO DISCONNECT FROM THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620589 ↗
• MalfunctionJun 21, 2021Break; Unintended Ejection; Break; Unintended Ejection

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO PUSHWIRE BREAK OR APPARENT DAMAGE. THE DEVICE SEEMED TO DISCONNECT FROM THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033797 ↗
• MalfunctionFeb 5, 2021Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11288947 ↗
• MalfunctionNov 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE DURING DELIVERY IN THE PHENOM MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN OFF-LABEL, FUSIFORM, BASILAR ARTERY DISSECTION WITH NORMAL VESSEL TORTUOSITY. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY PASSING THE PIPELINE THROUGH THE MIDPOINT OF THE PHENOM 27 MICROCATHETER. AN INTERMEDIATE CATHETER WAS NOT USED, ONLY A NEURON MAX 088 GUIDE. UPON REMOVING THE PHENOM, A KINK WAS OBSERVED. THE MANUFACTURING REPRESENTATIVE (REP) BELIEVED THE CATHETER KINKED WHEN THE ENTIRE SYSTEM PROLAPSED INTO THE AORTIC ARCH, BUT IT WAS PURELY THEORY AS IT WAS NOT VIEWED ON ANGIO. A CONTINUOUS FLUSH HAD BEEN USED, THE PHYSICIAN ATTEMPTED TO RELEASE THE LOAD IN THE SYSTEM TO RESOLVE THE ISSUE, BUT THE ISSUE DID NOT RESOLVE. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE OR PUSHWIRE. REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURE, AND POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THE TREATMENT WAS A SUCCESS. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10772529 ↗
• MalfunctionJun 24, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE EXPERIENCED RESISTANCE DURING ADVANCEMENT AND RETRIEVAL. THE DEVICE REPORTED TO HAVE SEPARATED DURING THIS DEVICE MANIPULATION BY THE USER. THE DEVICE WAS REMOVED VIA THE MICROCATHETER. A NEW PIPELINE WAS USED TO TREAT THE PATIENT. NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS USED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729566 ↗

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-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-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-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-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