PIPELINE PED-350-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536015395), received between May 7, 2019 and Jul 27, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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.

• MalfunctionJul 27, 2021Positioning Failure; Material Deformation; Activation Failure; Positioning Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL PART OF THE PIPELINE DID NOT OPEN. THE DOCTOR HAD TRIED TO "RECYCLE" AND REDEPLOY THE DEVICE TO TRY TO GET IT TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230238 ↗
• MalfunctionJan 6, 2021Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123354 ↗
• MalfunctionNov 19, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN, AND IT HAD BEEN PLACED IN A STRAIGHT SECTION OF THE BLOOD VESSEL AT THAT TIME. THE PIPELINE HAD BEEN RESHEATHED TWO TIMES, AND IT COULD NOT BE OPENED AFTER REPEATED PUSHES IN THE BLOOD VESSEL. IT WAS REPORTED THAT A PHENOM MICROCATHETER HAD BEEN USED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10868870 ↗
• MalfunctionMay 7, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE PIPELINE COULD NOT BE OPENED DURING RELEASE. IT WAS STATED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND AND MORE THAN 50% OF IT HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RE-SHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE WHICH INCLUDE WIRE/CATHETER. THE PIPELINE WAS REMOVED FROM THE PATIENT, BUT IT WAS NOT RE-SHEATHED AND REMOVED WITH THE MICROCATHETER. IT WAS PUSHED OUT FROM THE MICROCATHETER IN VITRO. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM AT THE LEFT CERVICAL CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 20MM AND A NECK DIAMETER OF 9MM. THE DISTAL LANDING ZONE WAS 2.9MM, AND THE PROXIMAL LANDING ZONE WAS 3.6MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MINIMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 0. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NOTED AS CONTRAST RETENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8588334 ↗

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-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-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-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