PIPELINE PED-250-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536014435), received between May 29, 2019 and Jun 29, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING RETRIEVING FROM THE PATIENT THE PUSHWIRE BROKEN AT THE MARKED POINT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN MIDDLE CEREBRAL ARTERY M1 SEGMENT, MEASURING 3.2MMX3.5MM, LANDING ZONE DISTAL 2.5MM, PROXIMAL 2.7MM. THE VESSEL WAS NORMAL TORTUOUS. IT WAS REPORTED THAT AFTER THE SUCCESSFUL DEPLOYMENT OF THE PED IMPLANT, WHEN THE SURGEON RETRIEVED THE DELIVERY GUIDEWIRE, THE PROTECTIVE SHEATH FAILED TO BE SUCCESSFULLY RETRIEVED INTO THE MICROCATHETER. THE DELIVERY PUSHWIRE AND THE MICROCATHETER WERE COMPLETELY WITHDRAWN FROM THE BODY, AND DURING THE WITHDRAWAL PROCESS, THE PROXIMAL END OF THE DELIVERY PUSHWIRE WAS BROKEN AT THE MARKED POINT. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. YES, DUAL ANTIPLATELET THERAPY ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWS SLOW BLOOD FLOW. NO PATIENT INJURY WAS REPORTED. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10209593 ↗
• MalfunctionMay 29, 2019Migration; Migration

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE WAS DISCOVERED TO HAVE MIGRATED APPROXIMATELY 15MM SIX MONTHS POST SUCCESSFUL EMBOLIZATION PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT AND THE PHYSICIAN IS CHOOSING NOT TO RETREAT THE PATIENT AT THIS TIME. IT WAS NOTED THAT THE DEVICE WAS SIZED APPROPRIATELY AT THE TIME OF THE INITIAL IMPLANT, EVEN THOUGH THE PROCEDURE WAS OFF LABEL (IMPLANTING IN ACOM). ALSO, SOME SIDE BRANCHES WERE COVERED BY THE PIPELINE IN THE A3 SEGMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED FUSIFORM ANEURYSM MEASURING 4MM X 4MM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY: A2-A3 JUNCTION. THE DISTAL AND PROXIMAL LANDING ZONE WERE UNKNOWN. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY. PATIENT WAS ON DUAL ANTIPLATELET THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8650126 ↗

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-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-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