PIPELINE PED-425-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536016118), received between Nov 27, 2019 and Mar 10, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DUE TO THE PATIENT¿S SEVERE VESSEL TORTUOSITY, ANY MOVEMENT FROM THE PHYSICIAN¿S STANDPOINT TO DELIVER THE PIPELINE DEVICE (IE, PUSHING WIRE, LOADING/UNLOADING, ETC) DID NOT HAVE THE EXPECTED RESULTS DISTALLY AT ALL. THIS IS CONFIRMED BY THE MD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454806 ↗
• MalfunctionMar 2, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PIPELINE WAS OPENED IN THE M1 ACCORDING TO THE IFU. IT WAS BROUGHT BACK TO THE LANDING ZONE AND CONTINUED TO OPEN UNTIL PROXIMAL 1/3 OF THE PIPELINE. THE BRAID WOULD NOT RESPOND TO MULTIPLE TECHNIQUES TOOPEN INCLUDING LOADING, UNLOADING, AND RESHEATHING. THE MIDDLE PART OF THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN PROXIMALLY. THE PIPELINE HAD BEEN RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 25MM. THE DISTAL LANDING ZONE WAS 3.68MM, AND THE PROXIMAL LANDING ZONE WAS 4.23. IT WAS NOTED THE VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, AND THE PRU LEVEL WAS STATED AS PLATELET INHIBITION 81%. ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL PIPELINE DEPLOYMENT. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANXILLARY DEVICES: 088 NEUROMAX SHEATH, 058 115CM NAVIEN GUIDE CATHETER, PHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399112 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BLEEDING CEASED, BUT THE CAUSE OF THE BLEEDING WAS UNKNOWN.

  Patient problems: Intracranial Hemorrhage; Loss of Vision

  MAUDE report 11028467 ↗
• MalfunctionJun 22, 2020Break; Break

  MEDTRONIC RECEIVED REPORT OF PIPELINE PUSHWIRE SEPARATION AT THE DISTAL SECTION. IT WAS REPORTED THAT THE PIPELINE DEPLOYED AS EXPECTED, HOWEVER, UPON RECAPTURING THE DELIVERY WIRE BROKE OFF WITHIN THE PHENOM MICROCATHETER NEAR THE HUB OF THE PHENOM. THE PATIENT UNDERWENT TREATMENT OF A LEFT, UNRUPTURED, SACCULAR PCOM ANEURYSM. THE MAX DIAMETER WAS 6 MM AND THE NECK WAS 5 MM. THE DISTAL LANDING ZONE WAS 3.5 MM AND THE PROXIMAL WAS 4.2 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE(IFU). ANCILLARY DEVICES: CEREBASE DA GUIDE SHEATH, NAVIEN .058 (B022496), PHENOM 27 FG15160-0615-1S FE20-033, ARISTOTLE A18-200-002 (LOT 502009).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10182308 ↗
• MalfunctionFeb 11, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A 4.33X4.7MM LANDING ZONE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT AFTER DEPLOYMENT, THE DOCTOR ATTEMPTED TO CAPTURE THE DELIVERY SYSTEM, BUT IT FELT DIFFERENT. THE SYSTEM WAS REMOVED WITHOUT ANY ISSUES, AND THEN IT WAS NOTED THE PROXIMAL SEGMENT OF THE PUSHWIRE HAD BROKEN. THE BROKEN SEGMENT WAS REMOVED FROM THE PATIENT VIA THE MICROCATHETER, AND THERE WAS NO FRICTION OR DIFFICULTY NOTED. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694870 ↗
• MalfunctionNov 27, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX INCOMPLETE OPENING DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF A LEFT ICA, UNRUPTURED, SACCULAR ANEURYSM. THE DISTAL LANDING ZONE WAS 3.7MM AND THE PROXIMAL WAS 4.1MM. THE VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, A PIPELINE FLEX WAS ATTEMPTED TO BE PLACED AND DID NOT OPEN IN THE MIDDLE AND PROXIMAL SECTIONS. THE DEVICE WAS RESHEATHED WITH THE MICROCATHETER AND REMOVED. THERE WERE NO REPORTS OF INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9386397 ↗

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-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-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-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