PIPELINE PED-275-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536014671), received between Nov 18, 2019 and Sep 14, 2023 — classified as 1 death, 4 malfunctions.

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

• MalfunctionSep 14, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED THAT AFTER ANGIOGRAPHY, AFTER PERFORMING 2D CALIBRATION OF THE NAVIEN TIP DIAMETER, THE BLOOD VESSELS WERE MEASURED. THE PROXIMAL DIAMETER OF THE DISTAL ANCHOR POINT M1 WAS 2.5MM, THE DIAMETER OF THE PROXIMAL LANDING POINT ANTERIOR TO THE OPHTHALMIC ARTERY WAS 2.9MM, AND THE LENGTH WAS 18MM. FOR SAFETY REASONS, CHOSE PED-275-20 DENSE MESH STENT FOR IMPLANTATION. THE ACCESS USED 6F-90 LONG SHEATH + 5F115NAVIEN. DELIVERED THE MARKSMAN STENT CATHETER TO THE M2 SEGMENT THROUGH THE GUIDE WIRE, AND WITHDREW THE GUIDE WIRE. UNPACKED THE STENT AND PERFORMED HIGH-PRESSURE INFUSION TO HYDRATE IT UNTIL 10 DROPS OF WATER WERE RELEASED. AFTER PRESSING THE DELIVERY SHEATH AGAINST THE MARKSMAN HUB PORT, DELIVERED THE STENT TO M2 SEGMENT. AFTER THE STENT CATHETER CAME OUT, OPENED THE TIP END OF THE STENT. THE TIP END OF THE STENT WAS OPENED BY ABOUT 6MM. THE OPENING WAS IN GOOD CONDITION. AFTER LOCKING THE Y VALVE, PULLED BACK AND ANCHORED. AFTER ANCHORING, DEPLOYED THE MIDDLE SECTION OF THE STENT UNDER FLUOROSCOPY. WHEN THE STENT WAS DEPLOYED TO THE NECK OPENING OF THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY, THE ADHESION OF THE STENT TO THE WALL WAS OBSERVED UND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17748810 ↗
• MalfunctionJul 19, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE, AND IT WAS RESHEATHED TWO TIMES. THERE WAS NO DAMAGE TO THE PIPELINE STENT, PUSHWIRE, OR CATHETER. THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY OF THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188752 ↗
• DeathMay 7, 2021Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT WAS DAMAGED/DEFORMED DURING IMPLANTATION AND THE PATIENT SUFFERED STROKE WI TH SUBSEQUENT ADVERSE SYMPTOMS. THE PATIENT UNDERWENT A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED 6.0 X 5.2 X 5.7 MM SACCULAR ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION WITH NECK MEASURING 3.1MM AND A SECOND ANEURYSM OF THE INTERNAL CAROTID M2 SEGMENT. IT WAS REPORTED THAT ON (B)(6) 2019, THE PIPELINE DEVICE WAS IMPLANTED USING THE DEVICE'S PROVIDED DELIVERY SYSTEM. AFTER THE RELEASE OF THE DEVICE, ANGIOGRAPHY SHOWED NO FLOW, AND LATER SLOW FLOW, AND THE WAS NOTED THAT THE PIPELINE HAD ¿TWISTED,¿ ¿PROLAPSED¿ OR ¿INVAGINATED¿ AFTER FULL DEPLOYMENT, LEADING TO A ¿NO FLOW¿ AND THEN A ¿LOW FLOW" IN THE INFERIOR PORTION OF THE PATIENT'S VESSEL. THE PHYSICIAN MADE REPEATED ATTEMPTS TO RETRIEVE THE PIPELINE DEVICE EMPLOYING TWO DIFFERENT BALLOONS, A NON-MEDTRONIC STENT RETRIEVER, AND A SOLITAIRE DEVICE BUT WITHOUT SUCCESS. POST-OPERATIVE EVALUATION LATER ON 1 MAY 2019 SHOWED THAT THE PATIENT HAD EXPERIENCED A STROKE INTRA-OPERATIVELY WITH POST-OPERATIVE ASSESSMENT OF NO CONTRACTION AND NO MOVEMENT IN THE LEFT LEG AND LEFT AR

  Patient problems: Cognitive Changes; Dysphagia/ Odynophagia; Dysphasia; Obstruction/Occlusion; Paralysis; Stroke/CVA

  MAUDE report 11791173 ↗
• MalfunctionOct 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE STENT AND MARKSMAN MICROCATHETER THAT HAD RESISTANCE DURING A PROCEDURE WHEN THE MARKSMAN WAS DAMAGED. THE PATIENT WAS BEING TREATED FOR A RIDE SIDE UNRUPTURED SACCULAR ANEURYSM OF THE MIDDLE CEREBRAL ARTERY WITH COILS FILLING AND STENT PLACEMENT FOR BLOOD FLOW DIVERSION. THE ANEURYSM MAX DIAMETER WAS 5.5MM AND THE NECK DIAMETER WAS 3.5MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE MARKSMAN CATHETER WAS IN PLACE IN THE DISTAL MIDDLE CEREBRAL ARTERY. THE PIPELINE STENT WAS ADVANCED THROUGH THE CATHETER BUT BECAME STUCK AT THE DISTAL END. BOTH DEVICES HAD TO BE WITHDRAWN TOGETHER FROM THE PATIENT'S BODY. UPON REMOVAL FROM THE PATIENT IT WAS DISCOVERED THAT THE DISTAL END OF THE CATHETER WAS FLATTENED. THERE WAS NO DAMAGE NOTED/REPORTED TO THE PIPELINE OR PIPELINE PUSHWIRE. THE CATHETER HAD BEEN FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE PER IFU. BOTH DEVICES WERE REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIO REVEALED PARTIAL CONTRAST AGENT RESIDUE REMAINED BUT NO PROCEDURE OR DEVICE ISSUE WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10673014 ↗
• MalfunctionNov 18, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PIPELINE WAS USED FOR AN INDICATION THAT WAS NOT APPROVED. THE DEVICE WAS TO BE PLACED FROM A1 TO CONTRALATERAL A2. WHILE THE PHYSICIAN WAS PLACING THE PIPELINE OVER THE ANEURYSM, IT WAS DETERMINED HALFWAY THROUGH THE DEPLOYMENT THAT IT WAS TOO LONG. WHEN REMOVING THE PIPELINE, THERE WAS SOME TENSION IN THE SYSTEM, AND IT BROKE WHILE FULLY INSIDE THE CATHETER AT THE PROXIMAL BUMPER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARAZINZED SALINE. IT WAS NOTED THAT THE PIPELINE BECAME STUCK IN THE DISTAL SECTION OF THE CATHETER AFTER RESHEATHING DURING THE REMOVAL OF THE DEVICE. THE PHYSICIAN REMOVED BOTH THE PIPELINE AND THE CATHETER. THERE WAS NO DAMAGE TO THE CATHETER; HOWEVER, THE PUSHWIRE WAS DAMAGED AT THE DISTAL SECTION SINCE IT BROKE AT THE PROXIMAL BUMPER DURING THE REMOVAL OF THE UNDEPLOYED PIPELINE. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE PATIENT WAS BEING TREATED FOR A SACCULAR, ACOM ANEURYSM THAT WAS PREVIOUSLY COILED WITH RESIDUAL NECK FILLING. THE DISTAL LANDING ZONE WAS 2MM, AND THE PROXIMAL LANDING ZONE WAS 2.6MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9338611 ↗

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-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-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