PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000284152), received between Sep 7, 2021 and Sep 25, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Retraction Problem

  Medtronic received a report that there was difficulty recapturing the pusher wire into the microcatheter. Pushwire stuck during retraction at the PTFE Sleeves was reported. The pushwire was not rotated during removal. The catheter and pushwire were not damaged. 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. The patient was undergoing surgery for treatment of a saccular, unruptured left paraopthalmic aneurysm with a max diameter of 3mm and a 3mm neck diameter. Landing zone: Distal: 2.8mm and Proximal: 3.7mm. It was noted the patient's vessel tortuosity was normal. DAPT (Dual antiplatelet treatment) was administered. PRU (Platelet Reaction Unit) level was 60. The angiographic result post procedure showed the stent deployed in the desired location. Ancillary devices include a Phenom 27 FG15150-0615-1S Microcatheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898168 ↗
• InjurySep 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT CORELAB REVIEW OF UNSCHEDULED DSA IMAGES TAKEN ON 06-SEP-2024 SHOWED 75-95% STENOSIS OF THE POSTERIOR CEREBRAL ARTERY AND SUPERIOR CEREBRAL ARTERY. ADDITIONALLY, CORE LAB REVIEW OF MRI ON (B)(6) 2024 AND NCCT ON (B)(6)2024 REPORTED POSTERIOR CIRCULATION INFARCTION.

  Patient problems: Hemorrhagic Stroke; Intracranial Hemorrhage; Stenosis; Thrombosis/Thrombus

  MAUDE report 20276292 ↗
• MalfunctionJan 5, 2024Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED REPORTED UPON RECAPTURING THE WIRE, THE PIPELINE WAS PUSHED INTO THE ANEURYSM. PHYSICIAN TRIED MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, BUT UPON RETRIEVAL ATTEMPTS THE DEVICE WAS FULLY PUSHED IN THE ANEURYSM. THE PHYSICIAN MADE THE DECISION TO LEAVE THE DEVICE IN THE ANEURYSM. NO DAMAGE TO THE PIPELINE OR PUSHWIRE WAS OBSERVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18451693 ↗
• MalfunctionOct 31, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PROXIMAL END OF THE PIPELINE WOULD NOT OPEN AFTER MULTIPLE TECHNIQUES. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE SECTION. THE PIPELINE WAS MORE THAN 50% DEPLOYED WHEN IT FAILED TO OPEN AND WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR RIGHT OPHTHALMIC ARTERY ANEURYSM. THE PROXIMAL LANDING ZONE ARTERY SIZE MEASUREMENT WAS 3.3MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.   ANCILLARY DEVICES INCLUDE AN INFINITY 6F SHEATH, SOFIA GUIDE CATHETER, AND A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039309 ↗
• MalfunctionMay 15, 2023Break; Unintended Ejection; Break; Unintended Ejection

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PREMATURELY OPENED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM IN THE PARAOPHTHALMIC. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL IS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED PIPELINE IN THE ICA. THE  DR. DID NOT THINK HIS INITIAL DEPLOYMENT WAS ALIGNED CORRECTLY AND WENT TO RESHEATH THE DEVICE INTO THE PHENOM 27 IN ACCORDANCE TO THE IFU. HOWEVER, DURING THIS PROCESS, IT APPEARED AS IF THE DEVICE FELL OFF OF THE RESHEATHING PAD. THE PHYSICIAN FELT AS IF THE SAFEST APPROACH WAS TO REMOVE THE PHENOM 27 WITH THE DEVICE PARTIALLY CAPTURED AND TO COMPLETE THE CASE WITH A NEW PHENOM 27 AS WELL AS A NEW PIPELINE SHIELD OF THE SAME SIZE. DEPLOYMENT WAS A TECHNICAL SUCCESS AND THE PATIENT IS DOING WELL. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE PIPELINE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930444 ↗
• MalfunctionFeb 15, 2023Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE BECOMING STUCK (LOCKED UP)/ RESISTANCE AT THE DISTAL SEGMENT OF THE CATHETER AND MOVEMENT DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT PARAOPHTHALMIC WITH A MAX DIAMETER OF 7 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE WAS 3.4 MM DISTALLY AND 3.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT IS UNKNOWN IF DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AN OPEN 3.5 MM X 16 MM PIPELINE DEVICE COVERING A PARAOPHTHLAMIC ANEURYSM WITH NO ISSUES. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY. THE FELLOW HAD A REALLY DIFFICULT TIME PUSHING DEVICE INTO MICROCATHETER. ONCE AT THE TIP OF THE MICROCATHETER, DEVICE WAS UNSHEATHED, PUSHED OUT ALLOWING THE DISTAL END TO OPEN. DEVICE WAS DRAGGED INTO PLACE AT THE LEVEL OF THE POSTERIOR COMMUNICATING ARTERY. DEVICE SLIPPED TOO PROXIMAL, IT WAS ATTEMPTED TO RESHEATH TO RELOCATE THE DISTAL END. THEY WERE NOT ABLE TO RESHEATH, AS THEY PULLED ON DELIVERY WIRE, THE DISTAL END OF THE DEVICE STAYED OPEN WHILE THE WIRE CAME BACK THROUGH THE DEVICE. THE TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378851 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT 2 DAYS POST PIPELINE FLEX WITH SHIELD IMPLANT, THE PATIENT DEVELOPED STROKE SYMPTOMS AND IT WAS OBSERVED THAT THE PIPELINE WAS THROMBOSED. THE PATIENT HAD THE PIPELINE IMPLANTED TO TREAT AN UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY (ICA) ANEURYSM. POST-PROCEDURE ANGIOGRAPHY SHOWED THE PIPELINE WAS FULLY OPEN AND WELL APPOSED BOTH DISTALLY AND PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED, HOWEVER, IT WAS NOTED THAT THE PATIENT HAD STOPPED TAKING PLAVIX DURING THE SAME TIME INTERVAL DURING WHICH THE EVENT OCCURRED.

  Patient problems: Thrombosis/Thrombus; Unspecified Nervous System Problem

  MAUDE report 15117057 ↗
• MalfunctionSep 7, 2021Retraction Problem; Migration; Retraction Problem; Migration

  ADDITIONAL INFORMATION WAS RECEIVED. THE VESSEL TORTUOSITY WAS NORMAL. A PHENOM 27 WAS USED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434755 ↗

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-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-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