PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000284497), received between Jul 13, 2020 and Apr 20, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS ENCOUNTERED DIFFICULTIES WITH OPENING AND WERE KINKED. ADDITIONALLY, A PHENOM 27 MICROCATHETER WAS BENT. THE PATIENT WAS UNDERGOING STENT ASSISTED COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM IN THE SUPERIOR HYPOPHYSEAL SECTION WITH A MAX DIAMETER OF 3 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.4 MM DISTALLY AND 4.0 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ICA ACCESS VESSEL DIAMETER WAS 4.08 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS GOOD. IT WAS REPORTED THAT ACCESS CATHETERS WERE ADVANCED TO THE TARGET LESION. A PHENOM 27 WAS ADVANCED TO THE M2 SEGMENT, AND A 4.5×10 MM PIPELINE DEVICE WAS DEPLOYED TO INITIATE BRAID OPENING. THE DEVICE WAS OPENED IN A STRAIGHT SEGMENT AND DID NOT APPEAR TO BE DEPLOYED ACROSS A BEND; HOWEVER, THE BRAID WAS DIFFICULT TO OPEN AND DID NOT FULLY EXPAND. PARTIAL OPENING REVEALED A SIGNIFICANT KINK AT THE DISTAL END OF THE BRAID, APPROACHING A 90 DEGREE ANGULATION. THE DEVICE WAS THEREFORE REMOVED. A SECOND 4.5×10MM PIPELINE DEVICE (LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931645 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED INTERMITTENT LIGHTHEADEDNESS. THE PATIENT WAS BEING TREATED FOR A LEFT C6 ICA ANEURYSM AT THE HYDROPHYSEAL WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAXIMUM DIAMETER 3 MM, DOME HEIGHT 3 MM, DOME WIDTH 3 MM AND NECK SIZE 3 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 3.8 MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM WAS 4.7 MM. SIGNIFICANT STASIS WAS NOTED AT THE END OF THE PROCEDURE. COMPLETE NECK COVERAGE WAS NOTED AT THE END OF THE PROCEDURE. POST IMPLANT ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROCEDURE WAS CLASS 3. THE ACCESS VESSEL WAS THE FEMORAL RIGHT. RIST WAS NOT USED. NO HOSPITALIZED OR A PROLONGATION OF AN EXISTING HOSPITALIZATION WAS REPORTED. THE PATIENT RECOVERED/RESOLVED ON (B)(6) 2024. THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE SUBJECT PRESENTED TO PRIMARY CARE PHYSICIAN ON (B)(6) 2024 FOR ROUTINE FOLLOW-UP AND NOTED THAT THEY HAD BEEN HAVING INTERMITTENT LIGHTHEADEDNESS. NO INTERVENTION OR ADDITIONAL TREATMENT WAS PERFORMED. THE STUDY DEVICE WAS SUCCESSFULLY IMPLANTED IN THE SUBJECT. WALL APPOSITION WAS ACHIEVED. SIDE BRANCHES WERE COVERED BY THE PIPE

  Patient problems: Dizziness; Hyporesponsive to stimuli

  MAUDE report 24164339 ↗
• MalfunctionNov 4, 2025Material Frayed; Component or Accessory Incompatibility; Material Deformation; Activation Failure; Material Frayed; Component or Accessory Incompatibility; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO PIPELINE DAMAGE OBSERVED PRIOR TO THE FIRST INSERTION IN THE MICROCATHETER. THE DEVICE WAS NOT DETERMINED TO BE DAMAGED UNTIL AFTER MULTIPLE FAILED DEPLOYMENT ATTEMPTS AFTER THE SYSTEM HAD BEEN REMOVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466027 ↗
• MalfunctionJun 9, 2025Break; Retraction Problem; Physical Resistance/Sticking; Break; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PUSHWIRE BROKE IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED TERMINUS ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2.5MM NECK DIAMETER. THE LANDING ZONE WAS 3.0MM DISTALLY AND 4.4MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS 40. IT WAS REPORTED THAT THE DEVICE WAS BEING RESHEATHED THROUGH TORTUOUS ANATOMY AND THE PUSHWIRE BROKE PROXIMAL TO THE RESHEATHING PAD. SINCE 90% OF DEVICE WAS RECAPTURED, ONCE THE DOCTOR RECOGNIZED THE PROBLEM, THE WHOLE DEVICE WAS REMOVED FROM THE PATIENT WITH THE PHENOM 27 MICROCATHETER. THERE WAS SEVERE FRICTION OR DIFFICULTY DURING RETRIEVAL. A NEW DEVICE WAS INSERTED AND SUCCESSFULLY DEPLOYED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. 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. ANCILLARY DEVICES INCLUDE A NEURON MAX 088 SHEATH, NAVIEN 058 115CM GUIDE CATHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170643 ↗
• MalfunctionJan 17, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE SHIELD STENTS FROM DIFFERENT LOTS THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE TO TREAT A LEFT INTERNAL CAROTID ARTERY (ICA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 2.5MM AND THE NECK DIAMETER WAS 3MM. PATIENT VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE FIRST PIPELINE WAS DELIVERED TO THE M2 SEGMENT WITH THE PHENOM 27 CATHETER; THE CATHETER WAS BROUGHT BACK TO THE M1 AND THE PIPELINE WAS UNSHEATHED BUT THE DISTAL END OF THE BRAID DID NOT OPEN. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PHENOM CATHETER WAS THEN ADVANCE TO "PUSH THE SLEEVES FORWARD." THE DISTAL END OF THE PIPELINE THEN APPEARED TO BE RELEASED FROM THE PTFE SLEEVES BUT THE DISTAL END STILL DID NOT OPEN COMPLETELY. SEVERAL WAGGING AND LOADING MANEUVERS WERE TRIED BUT THE STENT COULD NOT BE OPENED. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. SINCE IT COULD NOT BE OPENED, THE PIPELINE WAS RESHEATHED, REMOVED WITH THE MICROCATHETER, AND REPLACED WITH ANOTHER PIPELINE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179724 ↗
• MalfunctionJan 17, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE FIRST DEVICE APPEARED FRAYED AFTER REMOVAL. THERE WAS NO DETERMINATION AS TO WHY THE DISTAL END DID NOT OPEN FOR THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179715 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEVELOPED A STROKE POST PIPELINE INSERTION.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOMM). THE LANDING ZONE WAS 3.8 MM DISTALLY AND 4.1 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A GOOD RESULT, GREAT PLACEMENT. IT WAS REPORTED THAT PLACEMENT WENT WELL. DEVICE WAS PLACED DISTALLY RIGHT AT THE CAROTID TERMINUS. THERE WAS MINIMAL MANIPULATION OF THE WIRE AND CATHETER AFTER PLACEMENT TO ENSURE OPTIMAL WALL APPOSITION. THE PATIENT DEVELOPED AN ANTERIOR CHOROIDAL STROKE. 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).

  Patient problems: Stroke/CVA

  MAUDE report 17009900 ↗
• MalfunctionMar 30, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA CAVERNOUS SEGMENT. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.1MM DISTAL AND 4.3MM PROXIMAL. IT WAS REPORTED THAT THE PIPELINE WAS DEPLOYED DISTALLY TO PRE-FLIP PTFE SLEEVES. THEY RESHEATHED AND DRAGGED DOWN TO THE DISTAL LANDING ZONE. ONCE DEPLOYED, THE PIPELINE WAS NOT OPENING AS USUAL. AFTER 2 RESHEATHING ATTEMPTS, THE PIPELINE WAS REMOVED FROM THE PATIENT AND INSPECTED TO HAVE FOUND THE PTFE SLEEVES BEING FIRMLY CLOSED ON THE DISTAL BRAIDS. THE PIPELINE WAS NOT POSITIONED IN A BEND AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. NO OTHER STEPS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE SUCCESSFUL WITH NO OCCLUSION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER, TRAXCESS 14 GUDIEWIRE, CEREBASE 6F + PHENOM PLUS GUIDE CATHETERS, AND A BALT ECLIPSE 6X12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644640 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT WAS DAMAGED AT THE DISTAL END AND THEN DETACHED WITHIN THE PHENOM MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS BEING TREATED WITH FLOW DIVERSION FOR AN UNRUPTURED SACCULAR ANEURYSM OF A PARAOPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 6MM. PATIENT VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS NAVIGATED TO THE M1. THE PIPELINE STENT WAS BEING DEPLOYED USING THE DRAG AND DROP TECHNIQUE. WHEN GOING THROUGH THE BIFURCATION INTO THE INTERIOR CAROTID ARTERY (ICA) THE PIPELINE CAME OUT TOO QUICKLY AND WAS TOO CLOSE TO THE DISTAL NECK OF THE ANEURYSM. THE SURGEON RESHEATHED THE STENT AND NAVIGATED BACK TO THE MIDDLE CEREBRAL ARTERY (MCA) TO REATTEMPT STENT DEPLOYMENT. HOWEVER, DURING THE SECOND ATTEMPT, THE DISTAL TIP OF THE STENT HAD A FOLDED SHAPE AS IF IT HAD FOLDED OVER ON ITSELF. UPON ADVISEMENT FROM THE MANUFACTURER REPRESENTATIVE (REP) THE SURGEON RESHEATHED THE STENT TO REMOVE AND REPLACE. WHEN RETRIEVING THE STENT BACK THROUGH THE MICROCATHETER, THE STENT DETACHED FROM THE P

  Patient problems: Embolus; Muscle Weakness/Atrophy; Stenosis

  MAUDE report 10264838 ↗

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-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-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