PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000284237), received between Oct 19, 2021 and Apr 3, 2026 — classified as 3 injuries, 8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Positioning Failure; Unintended Ejection; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AMORPHOUS, UNRUPTURED ANEURYSM LOCATED AT PARIOPTHALAMIC WITH A MAX DIAMETER OF 9 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 3.3 MM DISTALLY AND 3.6 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WITH UNKNOWN DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE PIPELINE DEPLOYED IN M1. THE SURGEON RESHEATHED AND TRIED TO FLIP THE SLEEVES, THEY COULD GET THE SLEEVES FLIPPED TO DEPLOY DISTAL 1/3 OF DEVICE. THEY PULLED BACK TO GET IN POSITION, BUT THEY NOTICED THAT THE PED TIP COIL JUMPED BACK INTO DEVICE. THEY PULLED THE TIP COIL BACK TO DISTAL TIP OF PHENOM AND REMOVED PHENOM AND PIPELINE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD RESULT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A D085419, RFX058-105-08 GUIDE CATHETER,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779412 ↗
• MalfunctionOct 20, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT MENTION ANY FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. RESISTANCE APPEARED TO BE PRESENT ONLY DURING RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343180 ↗
• MalfunctionAug 6, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.6MM DISTALLY AND 4.28MM PROXIMALLY.   IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE TWO PIPELINE PED IMPLANTED STENTS. THE POLYTETRAFLUOROETHYLENE (PTFE) WINGS WOULD NOT ALLOW FOR RECAPTURE. IT APPEARED THAT WINGS NEVER ACTUALLY FLIPPED AND WERE CORKED INSIDE THE MICROCATHETER. THE PUSHWIRE (CAPTURE COIL) GOT STUCK DURING RETRACTION AT THE TIP OF THE MICROCATHETER, AND IT WAS NOT ROTATED DURING REMOVAL. THE PUSHWIRE AND THE CATHETER WERE NOT DAMAGED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS GOOD. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725541 ↗
• MalfunctionJun 30, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A RE-TREATMENT OF AN UNRUPTURED, SACCULAR VERTEBRAL ANEURYSM LOCATED IN THE RIGHT VERTEBRA WITH A MAXIMUM DIAMETER OF 7 MM AND A NECK DIAMETER OF 4 MM, THE PIPELINE FLEX SHIELD 3.75MM X 12MM WAS USED. AFTER DEPLOYMENT, THE PIPELINE DELIVERY CATHETER WOULD NOT RE-ENTER THE PHENOM 27 CATHETER, AND THE PTFE SLEEVES WOULD NOT ENTER THE PHENOM 27, NECESSITATING REMOVAL OF THE SYSTEM AS A UNIT, WHICH WAS NOT THE PREFERRED METHOD. THE VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNIT LEVEL WAS MEASURED AT 220. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS REPORTED AS GOOD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365832 ↗
• MalfunctionMay 6, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING THE PIPELINE EMBOLIZATION DEVICE AND PIPELINE FLEX SHIELD, THE STENT HAD MIGRATED CAUDALLY, RESULTING IN INCOMPLETE COVERAGE OF THE NECK OF THE ANEURYSM LOCATED AT THE LEFT C7 TERMINUS. THE ANEURYSM WAS UNRUPTURED AND SACCULAR WITH A MAXIMUM DIAMETER OF 3.7 MILLIMETERS AND A NECK DIAMETER OF 2.5 MILLIMETERS. ANGIOGRAPHIC IMAGING AT A ONE-YEAR FOLLOW-UP SHOWED OCCLUSION OF THE ANTERIOR CEREBRAL ARTERY AND POSTERIOR COMMUNICATING ARTERY. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, ALTHOUGH THE PLATELET REACTIVITY UNIT LEVEL WAS NOT TAKEN. THE PATIENT HAD A MEDICAL HISTORY OF CIGARETTE SMOKING, TYPE 1 DIABETES, OBESITY, HEADACHES, ANEMIA, ANXIETY, AND ARTHRITIS.NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES: GUIDE CATHETER 7 FRENCH ARMADILLO, MICROCATHETER MEDTRONIC PHENOM 027, GUIDEWIRE BRAND, SIZE, AND LOT NUMBER ARE NOT COLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968160 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE INDEX PROCEDURE DISCHARGE NOTE STATE THAT THE PATIENT DID WELL POST-OP. PATIENT HAD SOME LEFT FACIAL NUMBNESS AND PAIN/HEADACHE TO RIGHT EYE. IMPROVED WITH STEROIDS AND FLUIDS. PAIN WAS CONTROLLED ON PO PAIN MEDICATIONS. IT WAS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT OR ANY MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. IT WAS UNKNOWN IF THERE WAS AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR. THERE WAS NO ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE CLINICAL EVENTS COMMITTEE (CEC).

  Patient problems: Eye Pain; Headache; Numbness

  MAUDE report 18897504 ↗
• MalfunctionFeb 13, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM ON THE RIGHT SIDE. LANDING ZONE: DISTAL: 4 MM AND PROXIMAL: 4 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT THE END OF THE PIPELINE DELIVERY SYSTEM BECAME UNRESPONSIVE. DELIVERY WIRE FRACTURE. IT WAS REPORTED THAT PUSHWIRE BREAK OCCURRED IN THE DISTAL SECTION. THE BROKEN SEGMENT OF THE PUSHWIRE WAS REMOVED FROM THE PATIENT. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY. THE PIPELINE WAS REMOVED FROM THE PATIENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE PIPELINE 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 18699419 ↗
• InjuryJan 18, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS PREPARED AS PER INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS DELIVERED AND IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY. UPON DELIVERY AND IMPLEMENTATION, THE PIPELINE WAS IMPLANTED AND THE DELIVERY WIRE SEPARATED AT THE LEVEL OF THE PROXIMAL BUMPER. THE MEDICAL DOCTOR (MD) TRIED TO RETRIEVE THE DISTAL END OF THE DEVICE WITH A 2MM TULIP STYLE ENSNARE. THE DISTAL END WAS NOT ABLE TO BE RETRIEVED, SO THE DISTAL TIP WAS STENTED INTO PLACE WITH (2) 4.5 X 30MM ATLAS STENTS. THERE WAS A PUSHWIRE BREAK, IT DETACHED AT THE HYPOTUBE PROXIMAL TO WIRE WELD. THE BROKEN SEGMENT OF THE PUSHWIRE WAS NOT REMOVED FROM THE PATIENT. THE BROKEN SEGMENT IS LOCATED IN THE ANTERIOR GENU. THERE WAS FRICTION OR DIFFICULTY DURING ADVANCEMENT OF MODERATE SEVERITY. THE PIPELINE WAS IMPLANTED IN THE PATIENT. THE PATIENT WOKE UP WITH NO ADDITIONAL NEUROLOGICAL DEFICITS. 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 ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY AT LEVEL OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4.0MM AND A 2.5MM NECK

  Patient problems: Foreign Body In Patient

  MAUDE report 18533956 ↗
• MalfunctionApr 13, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. DOCTOR THINKS IT WAS BECAUSE THE RIST CATHETER WAS NOT GIVING MUCH SUPPORT DUE TO ANATOMY (FEMORAL). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC LOCATION. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2.5MM. THE DISTAL LANDING ZONE WAS 3.3MM AND THE PROXIMAL LANDING ZONE WAS 3.7MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 166. ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED. (WATSON LABEL).  THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIES. THE PIPELINE WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107962 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT WHO WAS IMPLANTED WITH 3 PIPELINE DEVICES EXPERIENCED VISUAL SYMPTOMS, HEADACHE, AND MUSCLE WEAKNESS. THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, SIDE BRANCH ANEURYSM LOCATED IN THE C6 SEGMENT OF THE LEFT ICA. THE MAX DIAMETER WAS 6.5MM, THE DOME HEIGHT WAS 5.5MM, THE DOME WIDTH WAS 5.6MM, AND THE NECK SIZE WAS 3.7MM. ALL 3 PIPELINES WERE SUCCESSFULLY IMPLANTED WITH COMPLETE NECK COVERAGE AND WALL APPOSITION ACHIEVED, AND THERE WAS SIGNIFICANT STASIS IN THE ANEURYSM POST PROCEDURE. THE OPHTHALMIC SIDE BRANCH WAS COVERED BY THE DEVICES. IT WAS REPORTED THAT PATIENT EXPERIENCED BILATERAL BLURRY VISION IMMEDIATELY AFTER A PROCEDURE. THIS IMPROVED THE SAME NIGHT. THE PATIENT ALSO EXPERIENCED A SEVERE HEADACHE (RATED 6/10), WITH THROBBING LOCALIZED WITH THE LEFT FRONTAL REGION OCCURRING THE SAME DAY AS THE PROCEDURE IN THE SAME REGION AS THE TREATED ANEURYSM. THE HEADACHE WAS ASSOCIATED WITH PHOTO/PHONOPHOBIA, WHICH WAS MANAGED BY ORAL MEDICATION. THE NEXT DAY THEY EXPERIENCED VISUAL FIELD DEFICIT, WITH SOME BLURRINESS IN THE UPPER VISUAL FIELD OF THEIR LEFT EYE. THIS INVOLVED APPROXIMATELY 10% OF THE VISUAL FIELD WHICH REMAINED STABLE

  Patient problems: Blurred Vision; Headache; Hematoma; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 13912857 ↗
• MalfunctionOct 19, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT PARAOPHLAMIC ARTERY WITH A 4MM NECK DIAMETER. THE LANDING ZONE WAS 3.56MM AT THE DISTAL END AND 3.8MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE FIRST PIPELINE SHIELD ATTEMPTED TO DEPLOY WAS THE (B)(4). DEPLOYMENT WAS SUCCESSFUL UNTIL THE LAST 1/4TH OF DEVICE. THE PATIENT HAD A HIGH AND TIGHT POSTERIOR GENU. THE PHYSICIAN UNLOADED SYSTEM AND LOADED SYSTEM MULTIPLE TIMES TO TRY AND OPEN AROUND THE GENU. THE PROXIMAL SECTION OF THE DEVICE WOULD NOT OPEN. HE DECIDED TO USE A SHORTER DEVICE. HE WENT TO RESHEATH THE PIPELINE WITH THE CORRECT 80% WIRE PULL 20% CATHETER PUSH AND THE DEVICE CAME OFF THE DELIVERY SYSTEM. FORTUNATELY, HE WAS ABLE TO ADVANCE THE NAVIEN 058 OVER THE PIPELINE AND PULLED THE ENTIRE SYSTEM OUT. HE GOT ACCESS AGAIN, THIS TIME CHANGING THE INTERMEDIATE CATHETER TO A PHENOM PLUS. HE ENCOUNTERED THE SAME PROBLEM ATTEMPTING TO OPEN THE PROXIMAL PORTION OF THE (B)(4). HE HAS TO LOAD AND UNLOAD MULTIPLE TIMES TRYING TO OPEN THE PROXIMAL END OF THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657622 ↗

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-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-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