PIPELINE PED-300-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536014916), received between Aug 3, 2020 and Nov 2, 2022 — classified as 3 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, 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.

• MalfunctionNov 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX THAT HAD RESISTANCE AND WAS STUCK IN THE MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 10MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED FOR 7 DAYS PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. AFTER THE MARKSMAN MICROCATHETER WAS POSITIONED IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA). THE PIPELINE WAS THEN SELECTED. THERE WAS SEVERE RESISTANCE WHEN THE PIPELINE WAS DELIVERED THROUGH THE MARKSMAN AND IT WAS UNABLE TO BE PUSHED OUT. THE DEVICES WERE WITHDRAWN TOGETHER AND IT WAS FOUND THE PIPELINE WAS STUCK WITHIN THE MARKSMAN. THE PROXIMAL END OF THE MARKSMAN WAS NOTED TO HAVE ACCORDION DAMAGE. THE PIPELINE WAS NOT NOTED TO BE DAMAGE. A NEW MARKSMAN MICROCATHETER WAS THEN PLACED IN THE DISTAL MIDDLE CEREBRAL ARTERY AND A PIPELINE FLEX (MODEL:PED-325-25) WAS DELIVERED AND DEPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715520 ↗
• MalfunctionSep 27, 2021Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE TIP END OF THE GUIDE WIRE WAS BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM IN THE LEFT VERTEBRAL ARTERY WITH AN UNKNOWN MAX DIAMETER AND AN UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT AFTER THE PED WAS DEPLOYED, THE TIP END WAS NORMALLY OPENED, AND THE TIP END OF THE GUIDE WIRE WAS BROKEN DURING THE RECOVERY AND REPOSITIONING PROCESS. THE PUSHWIRE WAS BROKEN, AS THE TIP COIL WAS DETACHED. THE BROKEN SEGMENT WAS ABLE TO BE REMOVED FROM THE PATIENT WITH THE CATHETER. IT WAS UNKNOWN HOW MANY TIMES THE PUSHWIRE WAS ROTATED TO DEPLOY THE PIPELINE. NO FRICTION OR DIFFICULTY WAS NOTED. THE PIPLEINE WAS REMOVED FROM THE PATIENT. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A SLOWED DOWN BLOOD FLOW. THE ISSUE WAS RESOLVED WITH THE EXPLANT. ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533242 ↗
• MalfunctionAug 3, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CLINOID SEGMENT WITH A MAX DIAMETER OF 9.17MM AND A 6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT AFTER THE PIPELINE WAS DEPLOYED, IT NEEDED TO BE RELOCATED AND ADJUSTED, BUT COULDN'T BE RETRIEVED. THE PATIENT'S BLOOD VESSELS WERE THIN, AND THE BLOOD VESSELS AT THE NECK OF THE ANEURYSM WERE CURVED. THE CATHETER BECAME KINKED IN THE MIDDLE SECTION, AND WHEN TRYING TO RETRIEVE THE PUSHWIRE, THE DISTAL END BROKE OFF. 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. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED UNOBSTRUCTED BLOOD VESSELS AND DENSE EMBOLIZATION OF THE ANEURYSM. ANCILLARY DEVICES INCLUDE A LONG SHEATH 8F, 5F NAVIEN 115, MARKSMAN 150.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10358205 ↗

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-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-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