PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000284244), received between Jan 30, 2024 and Apr 28, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 reports).

12 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.

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.

• MalfunctionApr 28, 2026Positioning Failure; Retraction Problem; Malposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT HAD DIFFICULT DELIVERY, FAILURE TO RECAPTURE, AND DEPLOYED IN THE WRONG PLACE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE (ARTERY SIZE) WAS 3.25MM DISTAL AND 3.73MM PROXIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH THE PLATELET REACTIVITY UNITS (PRU) LEVEL OF, "THERAPEUTIC." NO IMAGES ARE AVAILABLE FOR REVIEW. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS, "PIPELINE WAS DEPLOYED, BUT IT WAS DEPLOYED FROM THE M1 DOWN INTO THE INTERNAL CAROTID ARTERY. THE PHYSICIANS PLAN WAS TO BRING THE DEVICE DOWN INTO THE ICA, BUT HE ENDED UP DEPLOYING IT FROM THE M1 DUE TO LOSING HIS ABILITY TO MANIPULATE THE ADVICE. BUT HIS SECOND OPTION IF HE WAS NOT ABLE TO GET A DEVICE TO SIT IN THE ICA APPROPRIATELY WAS TO START FROM THE ONE SO THIS WAS ACTUALLY HIS BACKUP PLAN. I THINK THE ONLY REASON WHY THIS INCIDENT DID NOT CREATE AN ISSUE FOR THE PATIENT." IT WAS REPORTED THAT "THE PIPELINE DEVICE WAS DEPLOYED, PARTIALLY AN M1,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021527 ↗
• MalfunctionJan 13, 2026Material Frayed; Retraction Problem; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY RICA ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE WAS 2.8MM DISTALLY AND 3.6MM PROXIMALLY.  IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.  DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS 154. IT WAS REPORTED THAT THE PED PIPELINE WAS BEING DEPLOYED IN ANEURYSM BUT BECAUSE OF DISTAL LOCATION IN THE ICA, THEY DECIDED TO PUT THE DISTAL END OF THE PED IN M1. IT STARTED TO COME BACK TOO PROXIMALLY IN DEPLOYMENT. THUS, THEY RE-SHEATHED TO REPOSITION MORE DISTAL. THE PROCEDURE TOOK LOTS OF MANEUVERING AND WHEN THEY STARTED DEPLOYING THE PIPELINE AGAIN, IT APPEARED EITHER COMPRESSED OR FRAYED. THEY TOOK IT OUT AND PUT A DIFFERENT ONE IN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GREAT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24061724 ↗
• MalfunctionNov 19, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER A FLAWLESS DEPLOYMENT OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT, THE PIPELINE DELIVERY SYSTEM COULD NOT BE RETRIEVED THROUGH THE PHENOM 27 MICROCATHETER. THERE WAS TOO MUCH TENSION TRYING TO BRING IT IN SO THE SYSTEM WAS PULLED OUT TOGETHER AS A UNIT WITHOUT INCIDENT. IT WAS NOTED THAT THIS HAS BEEN ENCOUNTERED SEVERAL TIMES. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR DENSE MESH FLOW DIVERSION TREATMENT OF A POSTERIOR COMMUNICATING ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED A DUDE 0.082¿ INTERMEDIATE CATHETER FROM RADICAL MEDICAL. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. RESISTANCE WAS ENCOUNTERED IN THE DISTAL TIP OF THE CATHETER. THE DELIVERY SYSTEM AND MICROCATHETER WERE REMOVED TOGETHER AS THE PIPELINE PUSHER WIRE WAS NOT ABLE TO BE PULLED INTO THE MICROCATHETER. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596521 ↗
• MalfunctionNov 17, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO BE RESHEATHED WITH THE PHENOM 27 MICROCATHETER DUE TO THE PTFE SLEEVES AND THE CATHETER WAS DAMAGED. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION PROCEDURE TO TREAT A POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS ALSO 4MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. DURING DEPLOYMENT, THE PIPELINE COULD NOT BE RESHEATHED. IT SEEMS THE PTFE SLEEVES WERE JAMMED AT THE DISTAL TIP OF THE MICROCATHETER. THE PHENOM 27 MICROCATHETER SUSTAINED ACCORDION DAMAGE DUE TO THE PIPELINE PTFE SLEEVES BEING JAMMED INTO THE CATHETER DISTAL TIP. THE PIPELINE PUSHWIRE WAS NOT DAMAGED. THE SYSTEM WAS REMOVED AND ANOTHER PIPELINE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS "LOOKED GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571216 ↗
• InjuryFeb 7, 2025Structural Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE STENT, RISTH CATHETER, PHENOM PLUS CATHETER, AND PHENOM 27 CATHETER HAD VISUAL DISTURBANCES. PATIENT REPORTS HAVING DOUBLE VISION/DIFFICULTY FOCUSING WHEN LOOKING FAR LEFT/RIGHT INTO THE DI STANCE. BRIGHT SQUIGGLES ACROSS VISION BILATERALLY. DISORIENTATION WHEN VISUALLY OVERSTIMULATED. NO ACTIONS WERE TAKEN. THE EVENT IS NOT RESOLVED. BASELINE ANEURYSM CHARACTERISTICS: SIDE (HEMISPHERE): RIGHT. SEGMENT OF INTERNAL CAROTID ARTERY (ICA): C6. LOCATION OF ANEURYSM IN VESSEL: SIDE BRANCH. ANEURYSM MORPHOLOGY: SACCULAR. MAXIMUM ANEURYSM DIAMETER: 3MM. ANEURYSM DOME HEIGHT: 3MM. ANEURYSM DOME WIDTH: 2MM. ANEURYSM NECK SIZE: 2MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3.7MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 3.2MM. SIGNIFICANT STASIS AT THE END OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED NO ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE VISUAL DISTURBANCES. THE SITE STATED THAT THE RELATIONSHIP WAS CAUSAL TO THE PROCEDURE. SOURCE STATES THAT AT ELECTASIS, THEY IDENTIFIED A SMALL DVAF FROM THE RIGHT MMA (POSSIBLY EVD RELATED) AND THEY SEALED IT OFF USING NBCA GLUE. A RIGHT FRONTAL DAVF,

  Patient problems: Blurred Vision; Confusion/ Disorientation; Diplopia/Double Vision; Fistula; Headache; Ischemia Stroke; Nausea; Visual Disturbances

  MAUDE report 21332431 ↗
• MalfunctionDec 10, 2024Positioning Failure; Unintended Ejection; Material Deformation; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Unintended Ejection; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WERE NO REPORTED ISSUES IDENTIFIED WITH THE CATHETER USED. SITE REPORTED COMPLETE WALL AP POSITION, NECK COVERAGE AT THE END OF PROCEDURE. R & R WAS CLASS 3. COMPLETE STASIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892742 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration

  ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF THE PIPELINE MIGRATION WAS NOT DETERMINED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18610802 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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-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