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PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-12Recalls & reported problems

Micro Therapeutics, Inc. · STENT PED2-425-12 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
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000284411), received between Oct 5, 2021 and Aug 31, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Activation Failure7
  • Adverse Event Without Identified Device or Use Problem3
  • Physical Resistance/Sticking3
  • Activation, Positioning or Separation Problem2
  • Lack of Effect2
  • Structural Problem2
  • Unintended Movement2
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9
  • Aneurysm2
  • Stroke/CVA2
  • Blurred Vision1
  • Bruise/Contusion1
  • Foreign Body In Patient1
  • Headache1
  • Hematoma1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2026Structural Problem

    Patient problems: Aneurysm

    MAUDE report 50531779 ↗
  • InjuryMay 30, 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

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT EXPERIENCED A PERCUTANEOUS KYPHOPLASTY. THIS ADVERSE EVENT (AE) DID NOT LEAD TO HOS PITALIZATION. THE OUTCOME STATUS IS RECOVERED/RESOLVED WITH AN OUTCOME DATE OF (B)(6) 2025 THE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE PATIENT UNDERWENT KYPHOPLASTY FOR A MODERATE SUBACUTE COMPRESSION FRACTURE AT T8 WITH A MILD SUBACUTE COMPRESSION FRACTURE AT L2. FRACTURES ARE CONSIDERED RELATED TO SEVERE OSTEOPOROSIS (PRE-EXISTING). THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION, PROCEDURE, OR DEVICE. THE SPONSOR ASSESSMENT WAS "RESULT: YES," THEY ADJUDICATED AS NON-SERIOUS.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Vertebral Fracture

    MAUDE report 22118406 ↗
  • InjuryMar 27, 2025Break; Detachment of Device or Device Component; Activation Failure; Break; Detachment of Device or Device Component; Activation Failure

    MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PUSHWIRE BROKE/DETACHED AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.5MM AND PROXIMAL: 4.25MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A PATENT ICA. IT WAS REPORTED THAT AFTER POSITIONING THE PHENOM 27 IN THE M1 LOCATION, THE PIPELINE WAS INTRODUCED AFTER PROPER PREPARATION. THE STENT WAS ADVANCED UNTIL THE DISTAL TIP COIL WAS EVEN WITH THE PHENOM DISTAL MARKER. THE DEVICE WAS THEN PUSHED OUT OF THE MICROCATHETER WITH PROPER OPENING OF THE DEVICE. THE DEVICE WAS DRAGGED BACK UNTIL THE DISTAL DEVICE WAS IN THE COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE OPERATOR THEN PROCEEDED TO PUSH OUT THE DEVICE AROUND THE OPHTHALMIC BEND AND UP TO THE POINT OF NO RETURN. THE STENT WAS MILDLY FLATTENED IN THE HORIZONTAL CAVERNOUS/HYPOTHOSEAL WHEN THE PHYSICIAN ATTEMPTED TO ¿FLUFF¿ THE DEVICE BY PUSHING FORWARD AND BACK ON THE PHENOM. AFTER TWO OR

    Patient problems: Foreign Body In Patient

    MAUDE report 21712181 ↗
  • MalfunctionJan 8, 2025Activation, Positioning or Separation Problem; Lack of Effect; Activation, Positioning or Separation Problem; Lack of Effect

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE INCOMPLETE COVERAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21102285 ↗
  • MalfunctionSep 5, 2024Activation Failure; Activation Failure

    MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE STENT FAILED TO OPEN IN THE PROXIMAL SECTION. THE HEALTHCARE PROVIDER (HCP) ADVANCED AND STARTED TO DEPLOY THE 4.25X12 PIPELINE. THE DEVICE OPENED WELL DISTALLY AND PULLED BACK INTO POSITION DISTALLY. THE DEVICE WAS THEN DEPLOYED MORE AND THE FELLOW PACKED A BIT TOO MUCH AT THE NECK OF THE ANEURYSM, WHICH WAS THE WIDEST AREA IN THE DEPLOYMENT ZONE. THE DEVICE NEVER OPENED WELL PROXIMALLY AFTER THAT. IT WAS RECAPTURED AND NOT PACKED ASMUCH AT THE NECK, BUT STILL FLATTENED PROXIMAL TO THE ANEURYSM. THE DEVICE WAS TAKEN OUT WITHOUT ISSUE AND A 4.25X14 WAS PLACED WITHOUT INCIDENT. THE DISCARDED 4.25X12 LOOKED NORMAL WHEN REMOVED. A STAFF MEMBER ACCIDENTALLY THREW IT AWAY AFTER THE PROCEDURE. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHEDMORE THAN 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 3.8M

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20154039 ↗
  • InjuryJan 25, 2024Structural Problem; Activation Failure; Lack of Effect; Structural Problem; Activation Failure

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT RELATEDNESS TO THE DISEASE UNDER STUDY WAS "PROBABLE". THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE OR PROCEDURE. DSA ON (B)(6) 2023 REPORTED PERSISTENT FILLING OF PREVIOUSLY FLOW DIVERTED LEFT ICA CLINOID SEGMENT ANEURYSM MEASURING 4.3X4X2.3MM.

    Patient problems: Aneurysm; Bruise/Contusion; Hemorrhage/Blood Loss/Bleeding; Numbness; Stenosis

    MAUDE report 18583600 ↗
  • MalfunctionAug 9, 2023Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

    ADDITIONAL INFORMATION WAS RECEIVED THAT MULTIPLE PIPELINE DEVICE WERE BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT, JUST NORMAL DEPLOYMENT MOVEMENTS. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17494153 ↗
  • MalfunctionMar 13, 2023Activation Failure; Activation Failure

    MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE THAT FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.75 MM DISTALLY AND 4.1 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 6. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SUCCESSFUL ANEURYSM EXCLUSION. IT WAS REPORTED THAT THE DOCTOR TOOK THE PIPELINE DEVICE AND SUCCESSFULLY OPENED IT IN THE M1. HE RECAPTURED THE DEVICE AND TOOK THE ENTIRE SYSTEM INTO THE ICA TO DEPLOY THE DEVICE TO COVER THE P-COMM ANEURYSM. TECHNIQUE WAS USED PER IFU. ONCE THE DEVICE WAS IN THE ICA, IT WOULD NOT DEPLOY. IT WAS REPORTED THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION THAT OCCURRED. THE PIPELINE WAS POSITIONED IN A DISTAL BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO OTHER ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PAT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16531104 ↗
  • InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A PROCEDURE FOR DISTAL LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION WITH COILS AND FLOW DIVERSION. THE ANEURYSM MAX DIAMETER WAS 17MM AND THE NECK DIAMETER WAS 10MM. BLOOD FLOW AND VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH PRU LEVEL OF 80 NOTED. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). TWO PIPELINE FLEX WITH SHIELD STENTS WERE IMPLANTED; THE SECOND PIPELINE WAS PLACED TO ENSURE ADEQUATE DISTAL COVERAGE. THROMBUS WAS NOTED IN THE DOME OF THE ANEURYSM PRIOR TO PROCEDURE. DEPLOYMENT WAS STRAIGHTFORWARD WITH THE EXCEPTION OF SEMI-LIMITED VISUALIZATION DUE TO SIZE OF ANEURYSM. PROPER PLACEMENT AND APPOSITION WAS CONFIRMED WITH VIRTUAL DILUTION 3DRA. ON WEDNESDAY 12/28, PATIENT PRESENTED WITH STROKE SYMPTOMS, SECONDARY TO THROMBOSIS WITHIN THE PIPELINE CONSTRUCT. VESSEL WAS REVASCULARIZED WITH ASPIRATION THERAPY AND PATIENT WAS ADMITTED TO ICU WITH AN NIHSS OF 23, INTUBATED, AND PARALYZED.

    Patient problems: Paralysis; Stroke/CVA; Thrombosis/Thrombus; Unspecified Nervous System Problem

    MAUDE report 16092054 ↗
  • MalfunctionAug 11, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD THAT FAILED TO OPEN AT THE DISTAL END AND THEN FAILED TO RESHEATH IN THE PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 9MM AND THE NECK DIAMETER WAS 6MM. THE DISTAL LANDING ZONE WAS 3.5MM AND THE PROXIMAL LANDING ZONE WAS 4.3MM. VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH PRU LEVEL 143. IT WAS REPORTED THAT THE DEVICES WERE NOT PREPARED PER THE INSTRUCTIONS FOR USE (IFU); THE SURGEON BACK-FLUSHED THE PIPELINE ON THE TABLE BY INSERTING THE TIP INTO THE RHV AND INJECTION SALINE WITH A SYRINGE THROUGH THE SIDE PORT. THE MANUFACTURER REPRESENTATIVE (REP) THOUGHT IT WAS LIKELY THAT THE PIPELINE BRAID WAS WITHIN THE RHV DURING THIS PROCESS AND THAT THE RHV VALVE WAS TIGHTENED DOWN ON THE BRAID. DURING DEPLOYMENT, THE DISTAL END OF THE PIPELINE BRAID COULD NOT BE OPENED. RESHEATHING WAS ATTEMPTED AND THE PHENOM 27 MICROCATHETER COULD NOT BE ADVANCED TO RESHEATH. LESS THAN 50% OF THE BRAID WAS DEPLOYED WHEN THE FAILURE TO OPEN OCCURRE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15212441 ↗
  • MalfunctionJul 27, 2022Unintended Movement; Unintended Movement

    MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE HAD MOVEMENT DURING PLACEMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ICA. THE MAX DIAMETER WAS 7MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.1MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AT A THERAPEUTIC DOSE. IT WAS REPORTED THAT THE PIPELINE OPENED WELL DISTALLY. WHEN ATTEMPTING TO MOVE THE PIPELINE MORE PROXIMAL INTO THE ICA TO THE LANDING ZONE, THE PIPELINE MOVED TOO FAR DOWN AND WAS NOW NOT COVERING THE ANEURYSM NECK. THE PIPELINE WAS NOT ABLE TO TRACK MORE DISTAL, SO THE PHYSICIAN REMOVED THE DEVICE AND IMPLANTED A NEW PIPELINE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE PIPELINE MISSED THE LANDING ZONE AND JUMPED DURING DEPLOYMENT. THE CATHETER TIP WAS NOT MOVED DURING DEPLOYMENT, AND NO ADDITIONAL STEPS WERE REQUIRED TO REMOVE THE PIPELINE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED FULL VESSEL APPOSITION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUD

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15117408 ↗
  • MalfunctionApr 15, 2022Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION THAT UPON RETRIEVAL OF THE PIPELINE WIRE AND PHENOM 27 MICROCATHETER EXPERIENCED SIGNIFICANT RESISTANCE AND WAS UNABLE TO SAFELY RECAPTURE THE DELIVER WIRE. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION. PREVIOUSLY RUPTURED ANEURYSM TREATED IN (B)(6) 2021 COIL EMBOLIZATION EMERGENTLY. THE LOCATION WAS THE INTERNAL CAROTID ARTERY (ICA) IN THE RIGHT PCOM. IT WAS AMORPHOUS WITH A STATUS OF UNRUPTURED. THE MAS DIAMETER WAS 6 X 7MM AND A NECK OF 5MM. THE DISTAL LANDING ZONE WAS 4.1MM AND THE PROXIMAL WAS 4.3MM. VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT ICA WITH A DIAMETER OF 4.1MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. PRU LEVEL WAS 8. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS EXCELLENT ANEURYSM EMBOLIZATION. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU).  THE DOCTOR SUCCESSFULLY ADVANCED THE PIPELINE SHIELD DEVICE AND RECAPTURE ONE TIME TO ADJUST POSITION; SUCCESSFULLY DEPLOYED THE DEVICE. HOWEVER, UPON RETRIEVAL OF WIRE AND MICROCATHETER EXPERIENCED SIGNIFICANT RESISTANCE AND WAS UNABLE TO SAFELY RECAPTURE THE DELIVER WIRE. PULLED EVERYTHING OUT AS A SINGLE UNIT. NO SYMPTOMS WERE REPORTED. ANCILLA

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14118784 ↗
  • 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 13912863 ↗
  • MalfunctionOct 5, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE SLEEVE WAS FLIPPED IN A BOWL OF SALINE ON THE BACK TABLE PRIOR TO INSERTION INTO DELIVERY MICROCATHETER. THE DISTAL END OF THE BRAID THEREFORE WAS NOT PROTECTED AND COULD NOT HAVE GOTTEN DAMAGED, THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12577358 ↗

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-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-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-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-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-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-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

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Sources and updates

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