PIPELINE PED-475-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536016712), received between Mar 14, 2019 and Dec 22, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY OF THE PIPELINE, THERE WAS RESISTANCE AT THE DISTAL END OF THE CATHETER. WHEN ADJUSTING, THE PHENOM LOST ACCESS AND COULD NOT BE PUT BACK IN PLACE. AN ATTEMPT WAS MADE TO PUSH THE PIPELINE INTO A NEW MICROCATHETER IN VITRO, BUT IT FAILED. IT WAS NOTED A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, THE PHYSICIAN RELEASED THE SLACK IN AN ATTEMPT TO RESOLVE THE ISSUE, AND THERE WAS NO DAMAGE REPORTED TO THE DEVICES. REPLACEMENT PRODUCTS WERE 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. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED UNOBSTRUCTED BLOOD VESSELS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. ANCILLARY DEVICES INCLUDE A 6F ENVOY DA SHEATH, PHENOM 27 MICROCATHETER. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063914 ↗
• MalfunctionDec 8, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATED THAT THE PUSH WIRE WAS NOT DAMAGED. HOWEVER, THE DISTAL TINES OF THE DEVICE WERE FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972654 ↗
• MalfunctionOct 26, 2020Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

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

  MAUDE report 10737481 ↗
• MalfunctionSep 30, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE INITIAL PIPELINE WAS PLACED SLIGHTLY DISTAL TO THE DESIRED LANDING ZONE LEADING TO IT BEING SHORT PROXIMALLY. A SECOND PIPELINE WAS SELECTED TO FORM A CONSTRUCT. WHEN THE REPORTED PIPELINE WAS ADVANCED IN THE OVERLAPPING SECTION, THE DISTAL END BECAME DISFIGURED/CRUSHED. THE DISTAL END FAILED TO OPEN. IT WAS BELIEVED THIS WAS DUE TO THE OPERATOR OVER PUSHING THE PIPELINE INTO A TURN WHICH POSITIONED THE MIDDLE SECTION OF THE DEVICE IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED, RESHEATHING WAS PERFORMED LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. A REPLACEMENT PIPELINE OF A DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE. POST-PROCEDURE ANGIOGRAPHY SHOWED A GOOD OUTCOME. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 18 MM AND A 21 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

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

  MAUDE report 10608011 ↗
• MalfunctionJul 18, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX DELIVERY WIRE FRACTURE. THE PATIENT WAS UNDERGOING PLACEMENT OF THE PIPELINE FLEX IN THE TREATMENT OF AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE LEFT, PARAOPH THALMIC INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS DESCRIBED AS SEVERE. DURING THE PROCEDURE, A CONTINUOUS FLUSH WAS MAINTAINED. THE PIPELINE FLEX WAS REPORTEDLY PLACED IN THE INTENDED LOCATION. AT RECAPTURE OF THE PIPELINE FLEX DELIVERY WIRE, RESISTANCE WAS EXPERIENCED IN THE MICROCATHETER. THE DELIVERY WIRE FRACTURED AT THE POINT OF THE SODDER JOINT JUST PROXIMAL TO THE PTFE SLEEVES. THE DELIVERY WIRE WAS ABLE TO BE CAPTURED IN THE MICRO CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804166 ↗
• MalfunctionJun 27, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL END OF PIPELINE WOULD NOT OPEN DURING DEPLOYMENT. AFTER EXECUTING MULTIPLE TROUBLE SHOOTING STEPS, IT WAS ABLE TO RE-CAPTURED, AND REMOVED THE PIPELINE PRIOR TO COMPLETE IMPLANTATION. A 4.75X14 PIPELINE WAS THEN SUCCESSFULLY IMPLANTED. THE REPORTED DEVICE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RE-SHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE MADE. THE TREATING VESSEL WAS THE RIGHT ICA. THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 7MM AND THE NECK WAS 4MM. THE DISTAL LANDING ZONE WAS 3.75MM AND THE PROXIMAL WAS 4.5MM. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741846 ↗
• MalfunctionMar 14, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX TIP CAME APART WHEN IT WAS DEPLOYED. THEY STOPPED USING THE DEVICE AND USED A NEW PRODUCT. IT WAS DISCOVERED THAT ONE WIRE AT THE TIP WAS ORIENTED TOWARD THE PROXIMAL SIDE UNDER ANGIOGRAPHY. PRIOR TO THE EVENT, THE PIPELINE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. BEFORE REMOVING THE PROTECTIVE SLEEVES, THE DISTAL END OF THE FLOW DIVERTER HAD BEGAN TO DEPLOY INSUFFICIENTLY AND IT WAS CONFIRMED THAT THE DISTAL END OF THE PIPELINE WAS FRAYED. ANOTHER ATTEMPT TO DEPLOY AFTER RESHEATHING WAS DONE BUT IT WOULD STILL NOT DEPLOY. IT WAS CONFIRMED THAT ONE WIRE STRAND AT THE DISTAL END OF THE PIPELINE FACED THE PROXIMAL SIDE AND THE PIPELINE COULD NOT BE DEPLOYED EVEN WHEN IT WAS UNSHEATHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED ANEURYSM MEASURING 7.7MM LOCATED IN THE IC-PARACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY. THE DISTAL AND PROXIMAL LANDING ZONE ARE 3.9MM AND 4.8MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422860 ↗

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-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-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-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