PIPELINE PED-350-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536015241), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE THAT GOT STUCK IN A PHENOM27 MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR CEREBRAL ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED, AND THE CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS DELIVERED THROUGH THE PHENOM27 MICROCATHETER, AND SUCCESSFULLY DEPLOYED. THE DELIVERY WIRE WAS THEN, PULLED BACK INTO THE MICROCATHETER, BUT COULD NOT BE PULLED OUT. THE DELIVERY WIRE WAS RETAINED WITHIN THE MICROCATHETER, AND THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. ON A TABLE IN THE SURGICAL AREA, SURGICAL STAFF WORKED WITH THE DEVICES, AND WERE ABLE TO ADVANCE THE DELIVERY WIRE FORWARD OUT OF THE MICROCATHETER WITH EASE BUT AGAIN, BECAME STUCK PULLING BACK FOR RETRIEVAL, AND REMAINED STUCK IN THE MICROCATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER, AND NO DAMAGE TO THE PUSHWIRE OR CATHETER WAS OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10545087 ↗

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-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-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