PIPELINE PED-300-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536014732), received between May 14, 2020 and May 12, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE TO THE PHENOM 27 CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812847 ↗
• MalfunctionDec 8, 2020Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE WAS DEFORMED DURING DELIVERY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT WHEN THE PIPELINE WAS ADVANCED THROUGH THE MICROCATHETER, THE DISTAL TIP WAS VISUALIZED FLUOROSCOPICALLY AND THE PHYSICIAN NOTED THAT THE WIRE APPEARED TO BE DEFORMED. WHEN THE DEVICE WAS REMOVED FROM THE MICROCATHETER, THE DISTAL TIP WAS NOT STRAIGHT. THE PUSHWIRE DID NOT APPEAR TO BE DAMAGED DURING PREPARATION AND DELIVERY; HOWEVER, IT APPEARED TO HAVE BEEN DAMAGED PRIOR TO DELIVERY. NO FRICTION AT ALL WAS NOTED. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A PHENOM PLUS, PHENOM 27, SYNCHRO II, TARGET NANO 2 COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972013 ↗
• InjuryMay 14, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE THAT BROKE AT THE PROXIMAL MARKER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF A POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 3MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ONE PIPELINE WAS PLACED BUT MISSED THE DISTAL LANDING ZONE SO A SECOND PIPELINE WAS USED. AFTER THE SECOND PIPELINE WAS DEPLOYED, THE SURGEON WAS PULLING OUT THE PUSHWIRE WHEN IT DETACHED AT THE PROXIMAL MARKER AND WAS LEFT IN THE PATIENT. THE SURGEON ATTEMPT TO USE A SNARE TO REMOVE THE PUSHWIRE FRAGMENT FOR AN HOUR BUT COULD NOT REMOVE IT. A STENT WAS PLACED TO TACK DOWN THE WIRE. THE WIRE REMAINS IN THE PATIENT BUT NO FURTHER RELATED SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: PHENOM MICROCATHETER, NAVIEN-058 INTRACRANIAL SUPPORT CATHETER, NON-MEDTRONIC STENT, SHEATH AND GUIDEWIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10058289 ↗

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-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-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-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