PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-16Recalls & reported problems
Micro Therapeutics, Inc. · STENT PED2-400-16 V06 E-IFU · Class 3 · Implant
All models of PipelineTM Flex Embolization Device with Shield TechnologyTM (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000284343), received between Mar 27, 2022 and Jan 30, 2026 — classified as 6 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking6
- Adverse Event Without Identified Device or Use Problem5
- Retraction Problem4
- Activation Failure3
- Activation, Positioning or Separation Problem2
- Break2
- Material Deformation2
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Headache4
- Blurred Vision1
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
- Muscle Weakness/Atrophy1
- Obstruction/Occlusion1
- Stroke/CVA1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Retraction Problem; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT AFTER THE MARKSMAN CATHETER WAS IN PLACE, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS DELIVERED, AND THE STENT DEPLOYMENT PROCESS WAS SMOOTH. HOWEVER, AFTER DEPLOYING THE STENT AND WHEN RETRACTING THE STENT DELIVERY ROD, THE DISTAL END OF THE DELIVERY ROD COULD NOT BE RETRACTED INTO THE DISTAL CATHETER, RESULTING IN THE DISTAL RADIOPAQUE MARKER AND PROTECTIVE SLEEVE BEING OUTSIDE THE CATHETER. AT THIS POINT, THE SURGEON COULD ONLY WITHDRAW BOTH THE CATHETER AND THE DELIVERY ROD TOGETHER. UPON REMOVAL FROM THE BODY, IT WAS FOUND THAT THE CATHETER WAS SEVERELY DEFORMED, AND THE STENT DELIVERY ROD WAS OUTSIDE THE CATHETER, AFFECTING INTRAOPERATIVE MANIPULATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTRACRANIAL ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. RIGHT FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7.2 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223824 ↗MalfunctionAug 25, 2025Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DISTAL SECTION FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM AT C6 WITH A MAX DIAMETER OF 4.3 MM AND A 2.1 MM NECK DIAMETER. THE LANDING ZONE WAS 3.2 MM DISTALLY AND 4.15 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SLOWED BLOOD FLOW. IT WAS REPORTED THAT DURING THE ANEURYSM SURGERY, AFTER THE PIPELINE STENT WAS IN PLACE, THE TIP COULD NOT BE OPENED. AFTER IT WAS RETRIEVED AND ADJUSTED, THE MICROCATHETER AND THE INTERMEDIATE CATHETER WERE ADJUSTED, BUT IT STILL COULD NOT BE OPENED. THE STENT WAS REPLACED AND THE SURGERY WENT SMOOTHLY. THE PIPELINE WAS NOT POSITIONED IN A BEND, LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS REMOVED FROM THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AND WERE NOT USED OFF-LABEL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883864 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD A PIPELINE FLEX WITH SHIELD IMPLANTED TO TREAT A LEFT INTERNAL CAROTID ARTERY (ICA) C4 SEGMENT SACCULAR ANEURYSM VIA RIGHT RADIAL ACCESS. THE ANEURYSM MAX DIAMETER WAS 19MM AND THE ANEURYSM NECK WAS 6MM. AFTER THE PIPELINE WAS IMPLANTED, RAYMOND AND ROY ANEURYSM OCCLUSION CLASS 3 WAS NOTED WITH SIGNIFICANT STASIS IN THE ANEURYSM OBSERVED. THERE WAS NOT REPORTED DEVICE MALFUNCTION OR DEFICIENCY. POST-OPERATIVELY, NEUROLOGICAL DETERIORATION WAS NOTED; THE PATIENT EXPERIENCED NEW HEMIANOPSIA/QUADRANTANOPSIA ON THE RIGHT WITH RIGHT DRIFT. MAGNETIC RESONANCE IMAGING (MRI) SHOWED SCATTERED ACUTE INFARCTS. THE PATIENT'S DEXAMETHASONE WAS REDUCED TO 2 EVERY 12 HOURS. NO ADDITIONAL TREATMENT/INTERVENTION WAS REPORTED. HOWEVER, THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY. THE PATIENT WAS NOTED TO BE RECOVERING. SITE ASSESSMENT CONCLUDED THE EVENTS WERE PROBABLY PROCEDURE RELATED AND POSSIBLY RELATED TO THE PIPELINE AND/OR DUAL ANTIPLATELET TREATMENT (DAPT). THE DEVICE WAS SUCCESSFULLY IMPLANTED. WALL APPOSITION WAS ACHIEVED. SITE BRANCHES (OPHTHALMIC)
Patient problems: Headache; Stroke/CVA; Visual Impairment
MAUDE report 22879872 ↗MalfunctionJul 31, 2025Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED. DURING DELIVERY OF THE PIPELINE DEVICE, FRICTION AND RESISTANCE WERE ENCOUNTERED. THE MIDDLE SECTION OF THE STENT FAILED TO OPEN DESPITE ATTEMPTS AT RETRIEVING ADJUSTMENT. THE DEVICE WAS NOT DEPLOYED IN A VESSEL BEND AT THE TIME OF THE EVENT. THE FAILURE WAS ATTRIBUTED TO A SLIGHT KINK IN THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679436 ↗InjuryJun 18, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED A REPORT THAT THERE WAS RIGHT-SIDED WEAKNESS WITH AN ONSET DATE OF 2023-02-28. THIS ADVERSE EVENT (AE) RESULTED IN NEW HOSPITALIZATION FROM (B)(6) 2023 TO (B)(6) 2023. THE OUTCOME STATUS IS RECOVERED/RESOLVED WITH OUTCOME DATE OF (B)(6) 2023. THIS AE DID NOT RESULT IN BLOOD TRANSFUSION, PERCUTANEOUS INTERVENTION, OR SURGICAL PROCEDURE. AE RESULTED IN TREATMENT. AE OCCURRED POST-PROCEDURE. AE POSSIBLY RELATED TO THE DISEASE UNDER STUDY. AE DID NOT RESULT IN A NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS. AE DID NOT RESULT FROM A DEVICE DEFICIENCY. THE PARTICIPANT PRESENTED TO THE EMERGENCY DEPARTMENT WITH RIGHT-SIDED WEAKNESS. PARTICIPANT UNDERWENT UNREMARKABLE VEEG, TREATED FOR A HEADACHE, PLACED ON STEROID TAPER, ASSESSED BY PHYSICAL THERAPIST AND DISCHARGED. THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, OR MEDICAL INTERVENTION, AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THE AW WAS PROBABLY RELATED TO THE ANTIPLATELET MEDICATION, STUDY DEVICE, AND STUDY PROCEDURE AND NOT RELATED TO THE RIST. THERE WAS A GUIDEWIRE TO IMPROVE APPOSITION ON (B)(6) 2022. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, SIDEWAL
Patient problems: Headache; Muscle Weakness/Atrophy; Visual Disturbances
MAUDE report 22286321 ↗InjuryMar 11, 2025Device Dislodged or Dislocated; Unintended Movement; Migration; Device Dislodged or Dislocated; Unintended Movement; Migration
MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS SUCCESSFULLY WORKING AFTER THE SURGERY. THE STENT DISPLACEMENT WAS IDENTIFIED BY THE DOCTOR A YEAR LATER DURING A FOLLOW UP EVALUATION. THERE WAS MIGRATION AFTER DEPLOYMENT. THE CAUSE OF THE MIGRATION IS UNKNOWN. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION. FULL WALL APPOSITION WAS ACHIEVED. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT. AFTER THE SURGICAL PROCESSES, THE ANGIOGRAPHIC RESULTS (XPERCITY EVALUATION) WERE FAVORABLE. THE ADVERSE RESULTS WERE IDENTIFIED ON THE FOLLOW UP EVALUATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21575380 ↗MalfunctionJan 23, 2025Unintended Ejection; Physical Resistance/Sticking; Unintended Ejection; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT CAUSE OF THE RESISTANCE AND PREMATURE OPENING WAS NOT DETERMINED. THE PUSHWIRE WAS ONLY PULLED BACK/RETRACTED DURING THE RECAPTURING OF THE PTFE SLEEVES PROCESS AFTER THE PED WAS FULLY DEPLOYED. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE OR CATHETER, THE CATHETER APPEARED TO BE INTACT, VISUALLY. THIS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21219470 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED. REGARDING THE CAUSE OF THE DEEP VEIN THROMBOSIS, SOURCE DOCUMENTATION FROM ED VISIT STATED, ¿EXAM WITH BILATERAL 2+ PITTING EDEMA TO APPROXIMATELY 4 IN BELOW HER PATELLA WITH NO SIGNS OF ACTIVE INFECTION NO INCREASED WARMTH. SHE HAS ACTIVE 2+ PULSES ON HER DORSAL PEDAL BILATERALLY. HER LUNG SOUNDS WERE CLEAR AND EQUAL. I SUSPECT THAT THIS IS LIKELY VENOUS INSUFFICIENCY GIVEN THAT THE SYMPTOMS IMPROVE WHEN SHE IS LYING DOWN AND SHE HAS NO HISTORY OF HEART DISEASE AND LUNG EXAM WAS NORMAL.¿.
Patient problems: Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 20262999 ↗MalfunctionJun 21, 2024Break; Retraction Problem; Material Separation; Physical Resistance/Sticking; Break; Retraction Problem; Material Separation; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE AND DELIVERY SYSTEM BREAK WAS UNABLE TO BE DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583961 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT INCLUDED IN A CLINICAL STUDY WHO HAD A PIPELINE FLEX WITH SHIELD IMPLANTED ON 17- NOV-2023. POST-OPERATIVELY, ON 27-NOV-2023, THE PATIENT EXPERIENCED WORSENING HEADACHE AND WAS TREATED WITH MEDICATION (GABAPENTIN) AND NERVE BLOCK. THE SITE ASSESSMENT OF THE EVENT CONCLUDED THE EVENT WAS NOT RELATED TO THE PROCEDURE OR THE PIPELINE DEVICE BUT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY OR AN UNDERLYING CONDITION. IT WAS NOTED THE PATIENT HAS A HISTORY OF MIGRAINE HEADACHES. THE EVENT DID NOT RESULT IN PATIENT DISABILITY OR HOSPITALIZATION. IT WAS NOTED THE EVENT WAS NOT RESOLVED. ADDITIONAL INFORMATION HAS BEEN RECEIVED REPORTING THE CLINICAL EVENTS COMMITTEE (CEC) ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE, DEVICE, AND DISEASE UNDER STUDY. NON SERIOUS ADVERSE EVENT. CEC COMMENT: HISTORY OF HEADACHES PRESENTED WITH HEADACHE AND HAD PERSISTENT HEADACHE POST-TREATMENT.
Patient problems: Headache
MAUDE report 19221346 ↗MalfunctionApr 26, 2024Retraction Problem; Malposition of Device; Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Retraction Problem; Malposition of Device; Activation, Positioning or Separation Problem; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER WAS MOVED DURING DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19196409 ↗InjuryJan 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT SURGERY FOR A SACCULAR ANEURYSM OF THE LEFT VERTEBRAL ARTERY. DOME HEIGHT 1.2MM, DOME WIDTH 3.0MM, NECK LENGTH 3.9MM, DOME TO NECK RATIO 0.8MM. THE PATIENT HAS NOT YET RECOVERED. THE PATIENT RECEIVED A NERVE BLOCK AND CHANGE IN MEDICATION. ACTIONS TAKE TO RESOLVE THE WORSENING MIGRANE AND BLURRED VISION INCLUDED AN INCREASE IN DOSAGE OF GABAPENTIN, NERVE BLOCK AND BOTOX. IT WAS NOTED THAT THE PATIENT HAS MEDICAL HISTORY OF MIGRAINE HEADACHES FOR SEVERAL YEARS. SITE ASSESSED HEADACHE AS UNRELATED TO THE INDEX PROCEDURE, STUDY DEVICE AND ANTIPLATELET THERAPY. PER SITE, THE EVENT IS POSSIBLY RELATED TO THE DISEASE UNDER STUDY.
Patient problems: Blurred Vision; Headache
MAUDE report 18593023 ↗MalfunctionOct 7, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 5MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.5MM DISTAL, AND 3.89MM PROXIMAL. IT WAS REPORTED THAT THE PIPELINE AS WAS BEING DEPLOYED AROUND THE GENU AND WOULD NOT OPEN. MORE THAN 50% OF THE DEVICE WAS FULLY OPEN AND APPOSED DISTALLY, AS THE PHYSICIAN WAS OPENING THE DEVICE AROUND THE GENU THE DEVICE WOULD NOT OPEN. THE PHYSICIAN PARTIALLY RESHEATHED THE DEVICE AND CONTINUED DEPLOYING AND THE DEVICE WOULD NOT OPEN. THEY RESHEATHED THE WHOLE DEVICE, AND THE PIPELINE CONTINUED TO NOT OPEN. THE PIPELINE WAS REMOVED, AND IT WAS OBSERVED THAT THE DEVICE WAS CRIMPED/DAMAGED. THE PIPELINE HAD BEEN RESHEATHED 2 OR LESS TIMES, AND WAS NOT POSITIONED IN A BEND 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 GOOD. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15567627 ↗MalfunctionMar 27, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT UPON ADVANCING THE PIPELINE INTO THE MICROCATHETER, THE DEVICE BECAME OCCLUDED IN THE PROXIMAL PORTION OF THE MICROCATHETER. THE OPERATOR STOPPED ADVANCEMENT AS SOON AS THE RESISTANCE WAS FELT. THE OPERATOR ATTEMPTED TO RETRACT THE PIPELINE WHERE UPON THE DISTAL PORTION SEPARATED FROM THE PROXIMAL PORTION. THE DISTAL PORTION BECAME STUCK IN THE HUB OF THE MICROCATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PHYSICIAN RELEASED THE LOAN (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, HOWEVER, THE ISSUE WAS UNRESOLVED. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. THE PUSH WIRE WAS DAMAGED AS THE STENT DETACHED AT THE DISTAL SECTION. THE PIPELINE WAS PREPARED AS INDICATED IN THE IFU AND IT WAS NOT USED OFF-LABEL. ANCILLARY DEVICES INCLUDE: PHENOM 27, 150CM MICROCATHETER AND A PHENOM PLUS GUIDE CATHETER.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion
MAUDE report 13925201 ↗
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, ClassifiedMedtronic 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, ClassifiedMedtronic 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-2403-2021 · Jul 13, 2021 · Open, ClassifiedEV3 Pipeline Flex Embolization Device with Flex Shield Technology
- Z-2402-2021 · Jul 13, 2021 · Open, ClassifiedPipeline Flex Embolization Device
- Z-1527-2020 · Feb 14, 2020 · Terminatedev3 Pipeline Flex Embolization Device. For neurological endovascular use.
- Z-0307-2017 · Oct 5, 2016 · TerminatedPipeline 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 · TerminatedAlligator 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 · TerminatedMarathon 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 · TerminatedX-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-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 · TerminatedPipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
- Z-2045-2013 · Jul 19, 2013 · TerminatedPipeline 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
Other Intracranial aneurysm flow diverter devices
- Pipeline TM Flex Embolization Device with Shield Technology TM PED2-300-12Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter2 recalls1 report
- PIPELINE PED-500-20Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall31 reports
- PIPELINE PED-500-35Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death29 reports
- PIPELINE PED-500-16Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall2 deaths27 reports
- PIPELINE PED-500-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death23 reports
- PIPELINE PED-500-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall21 reports
- PIPELINE PED-450-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall20 reports
- PIPELINE PED-475-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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