PIPELINE PED-400-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536015784), received between Dec 5, 2019 and May 17, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2021Positioning Failure; Unintended Movement; Physical Resistance/Sticking; Positioning Failure; Unintended Movement; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832558 ↗
• InjuryDec 20, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED ADDITIONAL DETAILS: CTA SHOWED THAT THE WIRE HAS NOT MIGRATED AND IT DOES NOT SHOW THAT BLOOD IS STILL LEAKING INTO THE VEIN. THE DEVICE WILL NOT BE RELEASE AT THIS TIME. THE PATIENT WAS REPORTED TO BE HOME AND DOING WELL. MEDWATCH#: (B)(4) PATIENT ID (B)(6), FEMALE, 65 YEARS, 136 POUNDS, WHITE. DESCRIPTION: SUCCESSFUL DEPLOYMENT OF 4.00 MM X 10 MM PIPELINE EMBOLIZATION DEVICE IN GOOD POSITION. UPON RELEASE OF THE DEVICE DEPLOYMENT SECTION OF THE PUSHWIRE SEPARATED FROM THE PUSHER ¿HYPO¿ TUBE. FRAGMENT WAS RETAINED.

  Patient problems: Fistula; Foreign Body In Patient

  MAUDE report 9503529 ↗
• MalfunctionDec 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX DEVICE DID NOT OPEN IN THE MIDDLE SECTION DURING THE PROCEDURE. THE PATIENT UNDERWENT COILING TREATMENT FOR AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT SUPRACLINOID INTERNAL CAROTID ARTERY. MEASURING 5.7MM, LANDING ZONE 3.8MM PROXIMAL 3.8MM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. IT WAS REPORTED THAT STANDARD DEPLOYMENT PREPARATION, MEDTRONIC CATHETER IS M1 WITH WIRE OUT TO M2. COULD NOT GET THE PIPELINE TO OPEN. UNSHEATHED IT AT LEAST MORE THAN 2 TIMES. THE PHYSICIAN WENT THROUGH ALL OF THE TROUBLESHOOTING TECHNIQUES AND A LOT OF CATHETER MANIPULATION WITHOUT SUCCESSFULLY DEPLOYING THE PIPELINE. THE PIPELINE MIDDLE AND DISTAL SECTION POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9419349 ↗

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-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-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-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