PIPELINE PED-350-35 (UDI 00847536015487)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536015487), received between Mar 26, 2019 and Jun 28, 2021 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE MARKSMAN CATHETER AND PIPELINE STENT WERE IN PLACE, ANGIOGRAPHY FOUND BLEEDING. FINALLY, THE BLOOD VESSEL WAS CLOSED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED IN THE MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 13MM, AND THE NECK DIAMETER WAS 24MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL/NORMAL. THE LANDING ZONE WAS 3.4MM DISTAL AND 3.6MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 7MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS NOT ADMINISTERED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 12076117 ↗
• MalfunctionMar 26, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE MIDDLE SEGMENT OF THE PIPELINE WOULD NOT OPEN AFTER IT WAS DEPLOYED APPROXIMATELY LESS THAN 50%. ONLY THE DISTAL BRAID WAS OPENED AND APPOSED TO THE VESSEL WALL BUT THE MIDDLE SEGMENT WAS TWISTED. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES IN ATTEMPTS TO RESOLVE THE ISSUE, BUT WITHOUT SUCCESS. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 9MM X 6MM LOCATED IN THE INTERNAL CAROTID ARTERY. THE DISTAL AND PROXIMAL LANDING ZONE WAS 3.4MM X 3.6MM. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454511 ↗

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-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