Pipeline PED-375-35 (UDI 00836462015784)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015784), received between Aug 24, 2020 and Mar 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

12 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.

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.

• MalfunctionMar 24, 2021Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT WHILE THE PHYSICIAN TRIED TO ADVANCE THE PIPELINE INSIDE THE MICROCATHETER, THE PIPELINE GOT DEPLOYED INSIDE IT. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED AT THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 20MM AND A NECK DIAMETER OF 12MM. THE DISTAL LANDING ZONE WAS 3.2MM AND THE PROXIMAL LANDING ZONE WAS 4MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED INDICATED THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566655 ↗
• MalfunctionAug 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A MARKSMAN CATHETER AND PIPELINE THAT HAD RESISTANCE DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 11.77MM AND THE NECK DIAMETER WAS 9.21MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS RESISTANCE WITH A PIPELINE STENT IN THE DISTAL END OF THE MARKSMAN MICROCATHETER. THE SURGEON ATTEMPT TO REMOVED THE SLACK BUT THIS DID NOT RESOLVE THE ISSUE. THE DEVICES WERE REMOVED TOGETHER AND DAMAGE WAS OBSERVED TO THE CATHETER. THE DEVICES HAD BEEN PREPARED AND THE CATHETER CONTINUOUSLY FLUSHED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE. THERE WAS NO APPARENT DAMAGE TO THE PUSHWIRE. THE DEVICES WERE BOTH REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE DEVICE WAS PLACED IN A CURVE IN THE VESSEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446478 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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