PIPELINE PED-275-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536014640), received between Apr 29, 2020 and Jan 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING THE PROCEDURE, THE TIP OF THE PIPELINE STENT COULD NOT BE OPENED. THE PIPELINE WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS NOTED THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A PROCEDURE TO TREAT A RUPTURED AMORPHOUS RIGHT OPHTHALMIC ARTERY SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6.12MM AND THE NECK DIAMETER WAS 4.65MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. AFTER REPLACEMENT OF THE COMPLAINT PIPELINE, POST-PROCEDURE ANGIOGRAPHY SHOULD COMPLETED EMBOLIZATION AND CONTRAST RETENTION. ANCILLARY DEVICES: NAVIEN 6F 115CM CATHETER, MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366406 ↗
• MalfunctionAug 28, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX STENT THAT FAILED TO OPEN AT THE DISTAL END DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANERYSM OF THE MIDDLE CEREBRAL ARTERY. THE ANEURYSM MAX DIAMETER WAS 6.5MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE MICROCATHETER AND PIPELINE WERE IN PLACE AND THE PHYSICIAN BEGAN TO DEPLOY THE PIPELINE STENT. WHEN LESS THAN 50% OF THE STENT HAD BEEN DEPLOYED, IT WAS OBSERVED THAT THE DISTAL TIP COULD NOT BE OPENED. THE STENT WAS RESHEATHED AND REDEPLOYED MORE THAN 2 TIMES BUT STILL COULD NOT BE OPENED. NO OTHER STEPS WERE TAKE TO TRY OPENING THE PIPELINE. THE STENT WAS NOT POSITIONED IN A BED. FINALLY, THE STENT WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE CATHETER AND WAS REPLACED WITH A NEW PIPELINE THAT WAS DELIVERED AND DEPLOYED SUCCESSFULLY TO COMPLETE THE PROCEDURE. ALL DEVICES WERE PREPARED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. POST-PROCEDURE ANGIO SHOWED SLOWED BLOOD BLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10466302 ↗
• MalfunctionApr 29, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE GUIDEWIRE THAT BROKE DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF A COMMUNICATING ARTERY SEGMENT BETWEEN THE MIDDLE CEREBRAL ARTERY AND OPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 14MM AND NECK DIAMETER WAS 6MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE MANUFACTURER INSTRUCTIONS FOR USE. THERE WAS SOME MILD RESISTANCE OF NAVIGATION THROUGHOUT THE PROCEDURE RELATED TO THE PATIENT'S VESSEL TORTUOSITY BUT WAS ABLE TO REACH THE CORRECT LOCATION. AFTER THE PIPELINE WAS RELEASED, THE SURGEON PUSHED THE MARKSMAN CATHETER UP AGAIN TO DELIVER THE PIPELINE AND REMOVE THE PUSHWIRE. WHEN THE PUSHWIRE WAS PULLED BACK INTO THE CATHETER, THE SURGEON FOUND THAT IT HAD BROKEN AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. PUMP SUCTIONS WAS APPLIED TO THE CATHETER AND THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT TO AVOID ANY FRAGMENTS OF THE FRACTURED WIRE FROM BEING LEFT IN THE PATIENT'S VESSEL. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10009249 ↗

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-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-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-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-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-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-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