PIPELINE PED-375-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536015661), received between Dec 9, 2019 and Nov 21, 2021 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 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.

• MalfunctionNov 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM EMBOLIZATION BY FEMORAL ARTERY APPROACH AND IMPLANTED WITH PED. WHEN THE MICROCATHETER WAS IN PLACE, IT COULD NOT PUSH OUT THE MARKSMAN MICROCATHETER DURING PED DELIVERY, AND IT FAILED TO PASS THROUGH REPEATED ATTEMPTS. THERE WAS CATHETER RESISTANCE, IT WAS STUCK DURING DELIVERY, IN THE MIDDLE SECTION. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PHYSICIAN RELEASED THE LOAD IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE ISSUE DID NOT RESOLVE. IT WAS WITHDRAWN, THE CATHETER AND PED WERE REPLACED. THE SURGERY ENDED SMOOTHLY WITHOUT CAUSING INJURY TO THE PATIENT. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST PROCEDURAL ANGIOGRAPHIC RESULT SHOWED THE ANEURYSM COMPLETELY EMBOLIZED. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. THERE WAS NO PUSHWIRE DAMAGE. THE PATIENT WAS UNDERGOING SURGERY FOR AN UNRUPTURED AMORPHOUS ANEURYSM EMBOLIZATION. THE MAX DIAMETER WAS 5.6MM AND THE NECK DIAMETER WAS 5.11 MM. THE LANDING ZONE ARTERY HAD A DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850200 ↗
• MalfunctionJun 1, 2021Positioning Failure; Activation, Positioning or Separation Problem; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Activation, Positioning or Separation Problem; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO RESISTANCE DURING DELIVERY. THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND; IT WAS IN A HORIZONTAL SEGMENT OF THE M1. IT WAS ONLY ONE PIPELINE BEING USED WITH WAS MOVED WHEN WITHDRAWING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913562 ↗
• MalfunctionMay 14, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE LONG SHEATH, NAVIEN INTERMEDIATE CATHETER, AND PHENOM MICROCATHETER WERE ALL DELIVERED WITH NO ISSUES. UNDER FLUOROSCOPY, IT WAS SEEN THE STENT COULD NOT BE PUSHED OUT OF THE MICROCATHETER DURING THE PUSHING PROCESS DUE TO RESISTANCE IN THE MIDDLE SEGMENT. AFTER MANY FAILED ATTEMPTS, THE ENTIRE SYSTEM WAS WITHDRAWN FROM THE BODY. IT WAS THEN FOUND THE MIDDLE SECTION OF THE PHENOM MICROCATHETER WAS KINKED. A NEW PHENOM MICROCATHETER AND STENT WAS USED, AND IT WAS FOUND THE STENT COULD NOT BE PUSHED FORWARD DURING THE PUSHING PROCESS DUE TO RESISTANCE IN THE MIDDLE SEGMENT. IN THE END, THE ENTIRE SYSTEM WAS WITHDRAWN, AND THE PUSH ROD WAS FOUND TO BE BROKEN. THE DAMAGE WAS CLARIFIED TO BE KINKED IN THE PROXIMAL SEGMENT OF THE PUSHWIRE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE, AND REPLACEMENT PRODUCTS WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED/FLUSHED 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 TIGHT PACKING OF THE ANEURYSM, AND GOOD ADHESION OF THE STENT. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827379 ↗
• DeathSep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO DEPLOYING 3 PIPELINE DEVICES, 2 OTHER PIPELINE WERE ATTEMPTED TO BE DEPLOYED BUT ENCOUNTERED A LOT OF RESISTANCE AND HAD TO BE WITHDRAWN. THE DEVICES WERE REPLACED WITH LARGER SIZES. GIANT ANEURYSM WAS NOTED AS AN INCIDENTAL FINDING. THE PATIENT WAS TREATED SUCCESSFULLY WITH THE DEVICES, BUT EXPERIENCED A PERFORATOR STROKE 24 HOURS POST PROCEDURE, FOLLOWED BY A HEMORRHAGE AND DEATH. THE DEVICES WERE PREPARED PER THE IFU. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR LEFT MCA ANEURYSM WITH A MAX DIAMETER OF 15MM AND A NECK DIAMETER OF 8MM. ANCILLARY DEVICES INCLUDE A BENCHMARK GUIDE CATHETER, PHENOM 27 MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 10530967 ↗
• MalfunctionJul 29, 2020Break; Break

  MEDTRONIC RECEIVED SOME ADDITIONAL INFORMATION. THE VESSEL WAS NORMAL TORTUOUS. ANEURYSM LOCATED IN SUPRACLINOID INTERNAL CAROTID ARTERY. NO ADDITIONAL RESISTANCE PRIOR TO BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10338748 ↗
• MalfunctionJul 22, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE DISTAL WIRE BROKE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL RIGHT OPHTHALMIC ANEURYSM. THE VESSEL WAS MODERATELY TORTUOUS. NO PROCEDURE NEEDED TO REMOVE TIP IT FRACTURE AS IT CAME INTO MICRO CATHETER SO IT WAS TOTALLY HOUSED WITHIN THE MICROCATHETER. THE FRACTURE OCCURRED AFTER PED WAS DEPLOYED SUCCESSFULLY AS DELIVERY SYSTEM WAS BEING RECAPTURED WITHIN MICRO CATHETER. EVERYTHING IS TOTALLY FINE PATIENT IS DOING GREAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311629 ↗
• MalfunctionDec 9, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX (PED) FAILED TO OPEN AT THE DISTAL END. A WAIST WAS FORMED IN THE FAR SEGMENT. THE CUSTOMER RE-RETRIEVED THE DEVICE MANY TIMES AND RE-RELEASED, BUT THE SITUATION REMAINED THE SAME. UPON ASSESSMENT OF REMOVED PED, THE PED WAS STILL NOT OPENED. THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT, INTERNAL CAROTID CAVERNOUS SEGMENT. THE MAX DIAMETER WAS 11MM AND THE NECK WAS 8.2MM. THE DISTAL LANDING ZONE WAS 3MM AND THE PROXIMAL WAS 3.7MM. THE VESSEL TORTUOSITY WAS NORMAL. NO PATIENT INJURY OCCURRED. THE PIPELINE FAILED TO OPEN AT THE DISTAL SECTION AND DID NOT ACHIEVE WALL APPOSITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9440702 ↗

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-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-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-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