PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000284626), received between Oct 4, 2022 and Mar 31, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN WERE NOT IDENTIFIED. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WAS NO DEVICE ISSUE WITH THE PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741681 ↗
• MalfunctionMar 2, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS FAILURE TO OPEN OF THE PIPELINE DEVICES. THE PATIENT WAS UNDERGOING SURGERY FOR ANEURYSM FLOW-DIVERTING STENT IMPLANTATION PROCEDURE AS TREATMENT OF A FUSIFORM, UNRUPTURED RIGHT C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.2 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.6 MM DISTALLY AND 4.9 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A VESSEL DIAMETER OF 5.6 MM. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS RIGHT C6 SEGMENT ANEURYSM. SINCE THE TARGET LESION WAS A RIGHT C6 ANEURYSM, UNDER NEURO GUIDEWIRE GUIDANCE, THE PHENOM 27 MICROCATHETER WAS ADVANCED ALONG THE GUIDEWIRE AND PLACED TOWARD THE DISTAL VESSELS OF THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. AFTER THE PHENOM 27 MICROCATHETER WAS POSITIONED IN THE MIDDLE CEREBRAL ARTERY, THE OPERATOR ADVANCED THE FLOW-DIVERTING STENT PED2-500-20 TO THE MIDDLE CEREBRAL ARTERY AND BEGAN DEPLOYMENT. AT THAT TIME, IT WAS NOTED THAT APPROXIMATELY TWO-THIRDS OF THE PED2-500-20 STENT HAD ALREADY BEEN DEPLOYED, AND THE TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484687 ↗
• MalfunctionNov 17, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A FLOW DIVERSION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM LOCATED AT THE OPHTHALMIC ARTERY, THE PIPELINE EMBOL DEVICE 4.75MM X 18MM STENT TIP DID NOT OPEN COMPLETELY. IT WAS REPORTED THAT THE STENT, USING A MARKSMAN STENT MICROCATHETER WENT UPPER TO THE M1 LEVEL. THEY WITHDREW THE CATHETER AND OPENED, BUT THE STENT TIP DID NOT OPEN COMPLETELY AFTER SEVERAL ATTEMPTS. IT WAS THEN PULLED TOWARDS THE DISTAL END OF THE INTERNAL CAROTID ARTERY, BUT THE STENT TIP STILL DID NOT OPEN IDEALLY, FAILING TO ADHERE TO THE WALL AND COULD NOT BE ANCHORED DISTAL TO THE ANEURYSM. FURTHERMORE, FLUOROSCOPIC EXAMINATION REVEALED AN IRREGULAR STENT TIP MORPHOLOGY. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 4 MM AND A NECK DIAMETER OF 5 MM, WITH MODERATE VESSEL TORTUOSITY AND LANDING ZONE ARTERY SIZES OF 3.3 MM DISTAL AND 4.8 MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE STENT WAS WITHDRAWN AND REPLACED, RESULTING IN SUCCESSFUL COMPLETION OF THE SURGERY WITH A NORMAL ANGIOGRAPHIC RESULT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569810 ↗
• MalfunctionOct 15, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DISTAL TIP FAILED TO OPEN, AND THERE WAS PHENOM 27 RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED INTRACRANIAL INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT A NEURYSM WITH A MAX DIAMETER OF 9.14 MM AND A 6.46 MM NECK DIAMETER. THE LANDING ZONE WAS 4.52 MM DISTALLY AND 4.71 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 8.38 MM DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THE PRU LEVEL WAS NORMAL, ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT A PIPELINE WAS SELECTED FOR IMPLANTATION. AFTER ADEQUATE HYDRATION, THE PIPELINE WAS DELIVERED TO THE STENT CATHETER. DURING DEPLOYMENT OF THE FLOW DIVERTER, THE DISTAL END OF THE STENT DID NOT OPEN PROPERLY. THE SURGEON ATTEMPTED MULTIPLE TIMES, INCLUDING PUSHING, PULLING, RETRIEVING, REPOSITIONING, AND REDEPLOYING, BUT THE STENT STILL DID NOT OPEN SATISFACTORILY. CONSIDERING THAT REPEATED ATTEMPTS MIGHT HAVE CAUSED INTIMAL INJURY TO THE PATIENT'S VESSEL AND BEING CONCERNED ABOUT POTENTIAL ISSUES WITH THE PHENOM 27 AS WELL, THE STENT WAS RETRIEVED AND REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278237 ↗
• MalfunctionAug 15, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DAMAGE TO THE PIPELINE WAS FIRST OBSERVED AFTER DEPLOYMENT WHEN THE ANGLE OF ANGIOGRAPHY WAS CHANGED. THE DEVICE WAS POORLY ADHERE TO THE VESSEL WALL IN THE INTERNAL CAROTID ARTERY (ICA)/DISTAL MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOTED THAT THE DISTAL END OF THE PIPELINE WAS COMPLETELY OPENED BUT POORLY ADHERED TO THE VESSEL WALL. THE DISTAL BRAIDED WIRE HAD BURRS AND SOME WIRES APPEARED INCORRECTLY SHAPED. THE PROXIMAL END OF THE PIPELINE FAILED TO OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN THE PIPELINE FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR DEVICES USED TO ATTEMPT TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813625 ↗
• MalfunctionMar 28, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING AN INTRACRANIAL ANEURYSM EMBOLIZATION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE (PED2-475-18), THE STENT TIP COULD NOT BE OPENED AFTER MULTIPLE ATTEMPTS. THE ANEURYSM WAS UNRUPTURED, SACCULAR, AND LOCATED AT C7 WITH A MAXIMUM DIAMETER OF 7 MILLIMETERS AND A NECK DIAMETER OF 6 MILLIMETERS. THE DISTAL LANDING ZONE WAS 4.5MM AND THE PROXIMAL LANDING ZONE WAS 5MM. THE PROCEDURE WAS INTENDED TO TREAT THE ANEURYSM ACCESSED VIA THE FEMORAL ARTERY. DESPITE THE CATHETER BEING IN PLACE AND THE BLOOD VESSEL DIAMETER MEASURED, THE STENT TIP REMAINED CLOSED, LEADING TO THE CANCELLATION OF THE PROCEDURE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE DEVICE WAS EXPLANTED, AND THE PRODUCT WAS TO BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724555 ↗
• MalfunctionMar 18, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT WAS UNDERGOING ANEURYSM C4 SURGERY, TREATMENT WITH A DENSE MESH STENT. THE TIP END WAS POORLY OPENED AND THE PROXIMAL END OF THE STENT WAS SLIGHTLY UNLOADED DURING DEPLOYMENT. AFTER THE WHOLE WAS DEPLOYED, THE PROXIMAL END WAS NOT OPENED. HEALTHCARE PROVIDER (HCP) USED A 6F SHEATH TO PUNCTURE THE OTHER SIDE, AND PUSHED IT TO GO UPPER WITH A GUIDE WIRE AND ECHELON, AND PASSED THE ANTERIOR COMMUNICATING ARTERY TO THE RIGHT INTERNAL CAROTID ARTERY. AFTER THE GUIDE WIRE MASSAGED, THE STENT WAS OPENED AND THE OPERATION WAS COMPLETED. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED C4 ANEURYSM WITH A MAX DIAMETER OF 6.2MM AND A 4.8MM NECK DIAMETER. THE LANDING ZONE WAS 3.7MM DISTALLY AND 4.88MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS 6F. ANGIOGRAPHIC RESULT POST PROCEDURE REVEALED SLOW BLOOD FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924836 ↗
• MalfunctionMar 15, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY. LANDING ZONE: DI STAL: 4.5 MM AND PROXIMAL: 4.9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED ANEURYSM RETENTION. IT WAS REPORTED THAT THE TIP END OF THE STENT WAS ABNORMAL AND COULDN'T BE OPENED NORMALLY. AFTER RECOVERING THE TIP END, IT STILL COULDN'T BE OPENED. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE REPORTED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914145 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS RESOLVED BY COILING THE RUPTURE AND THE PATIENT IS RECOVERING. THE PATIENT EXPERIENCED HEADACHE AND TROUBLE SPEAKING AND MOVING RELATED TO THE ANEURYSM/INTRACRANIAL HEMORRHAGE. THE PATIENT IS CURRENTLY ADMITTED TO A HOSPITAL FOR MONITORING AND FOLLOW-UP IMAGING.

  Patient problems: Dyskinesia; Dysphasia; Headache; Intracranial Hemorrhage; Rupture

  MAUDE report 16809117 ↗
• MalfunctionOct 4, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED SACCULAR OPHTHALMIC ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH ACCEPTABLE PRU LEVEL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN ATTEMPTED TO OPEN THE PIPELINE IN THE ANTERIOR CEREBRAL ARTERY (ACA) BUT THE DISTAL END DID NOT OPEN. THE PIPELINE WAS RESHEATHED TWICE AND IT STILL WOULD NOT OPEN. IT WAS NOTED THAT PIPELINE WAS NOT POSITIONED IN A VESSEL BEND. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN WAS OBSERVED. OTHER THAN RESHEATHING TWICE, NO OTHER STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINE. IT WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE DEVICE WAS REPLACED WITH A PIPELINE (MODEL: PED2-475-16) WHICH WAS SUCCESSFULLY DELIVERED AND DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: PHENO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537598 ↗

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