PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000284329), received between Nov 16, 2021 and Mar 2, 2026 — classified as 1 death, 8 injuries, 12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE ENCOUNTERED RESISTANCE DURING RESHEATHING. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A BLISTER, UNRUPTURED LEFT ANTERIOR CHOROIDAL SEGMENT ANEURYSM WITH A MAX DIAMETER OF 2 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE WAS 2.96 MM DISTALLY AND 4.19 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS A SUCCESSFUL OUTCOME. IT WAS REPORTED THAT THE TIP COIL WAS BENT WHILE TRYING TO PULL THE DEVICE BACK TO TERMINUS LANDING ZONE. THE PHYSICIAN WAS NERVOUS THE TIP COIL MAY HAVE FALLEN OFF AND DECIDED TO PULL DEVICE AND REPLACE IT WITH A NEW ONE. THE TIP COIL WAS THOUGHT TO BE SEVERED WHILE RESHEATHING. THE PHYSICIAN DESCRIBED UNUSUAL RESISTANCE DURING RESHEATH MOVEMENTS. THERE WAS STUCK (LOCKED UP IN CATHETER OR RESISTANCE IN CATHETER. THE RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PIPELINE DID NOT BECOME STUCK. THE CATHETER WAS NOT DAMAGED. THE PUSHWIRE WAS NOT DAMAGED. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED(OFF-LABEL). THE PIPELINE AND ACCESSORY DEVICES WERE PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488342 ↗
• MalfunctionJan 9, 2026Structural Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT FOLLOW-UP IMAGING DAY 180 DSU IT WAS REPORTED THAT THE SUBJECT HAD AN ANTERIOR CEREBRAL ARTERY (ACA) BRANCH ARTERY STENOSIS OF 5-25%, HOWEVER, POSTERIOR COMMUNICATING ARTERY (PCOM) BRANCH WAS REPORTED TO BE ANGIOGRAPHICALLY OCCLUDED. SITE DID NOT REPORT ANY AES. SITE DID NOT REPORT ANY BRANCH ARTERY STENOSIS. THERE WAS NO ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR, SPONSOR, OR CLINICAL EVENTS COMMITTEE. THERE WAS NO IMPACT TO PATIENT REPORTED. THE SITE DID NOT REPORT ANY MEDICAL INTERVENTIONS. MEDTRONIC RECEIVED A REPORT THAT AT 1 YEAR POST-IMPLANTATION OF THE PIPELINE THE CORE LAB REPORTED AN ANEURYSM OCCLUSION RESIDUAL NECK. BRANCHES ARISING FROM THE PARENT ARTERY WITH A DEGREE OF STENOSIS INCLUDE THE ANTERIOR CEREBRAL ARTERY WHICH HAD 51-75% OCCLUSION AND THE POSTERIOR COMMUNICATING ARTERY WHICH WAS ANGIOGRAPHICALLY OCCLUDED. THERE WERE NO KNOWN PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE STENOSIS WAS NOT DETERMINED; HOWEVER, THE SITE REPORTED THAT COMPLETE NECK COVERAGE WAS ACHIEVED. THE PRINCIPAL INVESTIGATOR INDICATED THAT THE ANEURYSM WA

  Patient problems: Obstruction/Occlusion; Stenosis; Vasoconstriction

  MAUDE report 24027510 ↗
• MalfunctionAug 18, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE PUSHWIRE COULD NOT BE PULLED BACK INTO THE PHENOM 27 MICROCATHETER FOR RETRIEVAL AFTER PIPELINE DEPLOYMENT. IT WAS NOTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SYSTEM (MICROCATHETER AND PUSHWIRE) WAS REMOVED TOGETHER AND INSPECTED AND IT WAS CONFIRMED IN VITRO THAT THE PIPELINE PUSHWIRE COULD NOT BE PULLED INTO THE PHENOM 27. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO UNDERWENT SUCCESSFUL FLOW DIVERTER STENT IMPLANTATION TO TREAT AN INTERNAL CAROTID ARTERY (ICA) UNRUPTURED BLISTER ANEURYSM. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET (DAPT) WAS ADMINISTERED. ANCILLARY DEVICE: NAVIEN 072 115CM CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829162 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A STROKE. THIS ADVERSE EVENT (AE) LED TO A NEW HOSPITALIZATION FROM (B)(6) 2025. THIS AE RESULTED IN THE PATIENT BEING GIVEN THROMBOLYTIC MEDICATION. THIS AE DID NOT RESULT IN TREATMENT WITH A BLOOD TRANSFUSION, PERCUTANEOUS INTERVENTION, OR SURGICAL PROCEDURE. THE OUTCOME STATUS IS RECOVERED/RESOLVED WITH AN OUTCOME DATE OF (B)(6) 2025. AE DID NOT RESULT IN DIAGNOSTIC PROCEDURE OR TESTS BEING PERFORMED. THE EVENT OCCURRED POST-PROCEDURE AND WAS NOT RELATED TO THE DISEASE UNDER STUDY. THIS EVENT DID NOT RESULT IN A NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS AND DID NOT RESULT FROM A DEVICE DEFICIENCY. THE PATIENT WAS ADMITTED TO OSH (OUTSIDE HOSPITAL) FOR STROKE LIKE SYMPTOMS. THE SITE ASSESSED THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION, PROCEDURE, OR DEVICE. THE SPONSOR ASSESSMENT WAS "RESULT: YES" SOURCE DOCUMENTS HAVE BEEN REQUESTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, LEFT INTERNAL CAROTID ARTERY (ICA) C7 SIDEWALL ANEURYSM WIT

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784910 ↗
• MalfunctionAug 7, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY (ICA) PARAOPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF3.5 MM AND A 3.0MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.3MM DISTALLY AND 3.9MM PROXIMALLY. THE ACCESS VESSEL WAS GROIN, WITH 4-6MM DIAMETER. IT WAS REPORTED THAT AFTER DEPLOYING THE PIPELINE PED, THE PHYSICIAN WAS UNABLE TO PULL THE SLEEVES INTO THE PHENOM 027 CATHETER AND ENCOUNTERED RESISTANCE AT THE DISTAL SECTION. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A GOOD RESULT; THE DEVICE WAS WELL APPOSED. THE PIPELINE DID NOT GET STUCK, AND THE CATHETER AND PUSHWIRE WERE NOT DAMAGED. 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 SYNCHRO 014 GUIDEWIRE, PHENOM 27 MICROCATHETER, SOPHIA EX 6FR GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738515 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WAS NO TREATMENT DONE TO RESOLVE THE NUMBNESS/INFARCTION. SPONSOR HAS ASSESSED AS POSSIBLY RELATED TO DEVICE, DISEASE UNDER STUDY AND ANTIPLATELET MEDICATION. THE CAUSE OF THE NUMBNESS/INFARCTION WAS NOT DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT CORE LAB HAS REPORTED AT 1 YEAR IMAGING ON (B)(6) 2025 THAT BRANCHES ARISING FROM THE PARENT ARTERY HAVE A DEGREE OF STENOSIS: POSTERIOR COMMUNICATING (PCOM) ARTERY, ANGIOGRAPHICALLY OCCLUDED. IT WAS UNKNOWN IF ANY IMPACT TO THE PATIENT OR ANY IF ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. THE PATIENT'S MEDICAL HISTORY INCLUDES: MEDICAL / SURGICAL CONDITION: MIGRAINE; START DATE UNK REPAIR OF ANKLE FRACTURE; START DATE UNK LITHOTRIPSY X2; START DATE UNK SELECTIVE CATHETERIZATION EA 1ST ORDER THORACIC/BRCH/CPHLC; START DATE (B)(6) 2024 ARTHROSCOPY HIP W/LABRAL REPAIR RIGHT; START DATE UNK KIDNEY STONE REMOVAL; START DATE UNK SELECTIVE CATHETER CAROTID/INNOMINATE ART ANGIO; START DATE (B)(6) 2024 SELECTIVE CATHETER INTRNL CARTOID ART ANTIO; START DATE (B)(6) 2024 SELECTIVE CATHETER VERTEBRAL ART ANGIO; START DATE (B)(6) 20

  Patient problems: Blurred Vision; Diplopia/Double Vision; Fatigue; Headache; Ischemia Stroke; Nervous System Injury; Numbness; Obstruction/Occlusion; Pain; Stenosis; Visual Disturbances

  MAUDE report 22329459 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT EXPERIENCED HEMIPARESIS IN THEIR RIGHT ARM A WEEK AFTER THEY WERE IMPLANTED WITH A PIPELINE AND 12X30MM AXIUM FRAME COIL. THE PIPELINE HAD BEEN DEPLOYED WITH NO ISSUES. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT OPHTHALMIC SEGMENT. THE MAX DIAMETER WAS 15X17MM, AND THE NECK DIAMETER WAS 5MM. THE LANDING ZONE WAS 2.23MM DISTAL AND 3.67MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED.   ANCILLARY DEVICES INCLUDE A COOK 7F SHUTTLE GUIDE CATHETER, PHENOM 27 MICROCATHETER, ECHELON 10 MICROCATHETER, AND SYNCHRO STANDARD GUIDEWIRE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEMIPARESIS WAS CAUSED BY A PARENCHYMAL HEMORRHAGE ON THE IPSILATERAL SIDE. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE HEMORRHAGE. THE PATIENT CONDITION WAS THE SAME AS WAS PREVIOUSLY REPORTED.

  Patient problems: Intracranial Hemorrhage; Paresis

  MAUDE report 21973311 ↗
• InjuryAug 22, 2024Collapse; Material Deformation; Adverse Event Without Identified Device or Use Problem; Collapse; Material Deformation; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED ANCILLARY DEVICES USED RIST RADIAL ACCESS 079; OTHER: RIST RADIAL ACCESS SIM2. PRIMARY INTRACRANIAL SUPPORT CATHETER: NAVIEN 058. THE PATIENT WAS BEING TREATED FOR A SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) C6 TERMINUS.

  Patient problems: Dizziness; Visual Disturbances

  MAUDE report 20032056 ↗
• MalfunctionJul 22, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE LESION CHARACTERISTICS WERE MEDIUM INTERNAL CAROTID ARTERY (ICA) ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO PATIENT INJURY, JUST THE DEVICE TOOK AWHILE TO FINALLY OPEN AND DID EVENTUALLY OPEN. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS WELL OPPOSED AFTER IT OPENED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. PHYSICIAN WAS WELL BEYOND THE PROXIMAL BUMPER AND YET DEVICE FAILED TO OPEN. HE THEN WAGGED THE WIRE REPEATEDLY AND STARTED TO OPEN BUT BARELY. WHEN HE WENT TO RECAPTURE THE WIRE, DEVICE WAS PUSHED FORWARD AND THEN BECAME OPPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791206 ↗
• InjuryMar 22, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Lack of Effect; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS ADMINISTERED 75 MG OF NURTEC DUE TO WORSENING OF ADVERSE EVENT ON (B)(6) 2024. RIGHT SIDED NUMBNESS ONE MONTH POST PROCEDURE. CONSERVATIVELY ASSESSED AS RELATED TO PROCEDURE/DEVICE/THERAPY. CEC ASSESSED AS UNRELATED TO DEVICE, PROCEDURE OR APPOINTMENT. SIMILAR TO SYMPTOMS PRE-PROCEDURE.

  Patient problems: Numbness

  MAUDE report 18963556 ↗
• MalfunctionOct 4, 2023No Apparent Adverse Event; Activation Failure; Migration; No Apparent Adverse Event; Activation Failure; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO MIGRATION OF THE PIPELINE DEVICE AND THE PIPELINE DID NOT FAIL TO OPEN. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE PIPELINE DEVICE BUT RATHER IT WAS THE SURGEON'S CHOICE TO REMOVE THE SYSTEM AND RECATHETERIZE. AS THERE WAS NO DEVICE MALFUNCTION AND NO PATIENT INJURY, THE EVENT DOES NOT MEET THE DEFINITION OF A COMPLAINT. ***THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE.***

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872764 ↗
• InjurySep 8, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE PIPELINE DELIVERY WIRE SEPARATED AT THE POINT OF THE PROXIMAL BUMPER IN THE MIDDLE SECTION. DURING THE DEPLOYMENT, APPROXIMATELY HALF OF THE PIPELINE WAS OPEN WHEN THE PHYSICIAN FELT A CHANGE IN THE RESISTANCE OF THE PUSHER WIRE. UNDER FLURO, THE PHYSICIAN NOTICED THE PUSHER WIRE HAD FRACTURED AT THE POINT OF THE PROXIMAL BUMPER. THE PIPELINE WAS NOT DEPLOYED BUT THE PIPELINE WAS FULLY REMOVED ALONG WITH THE PHENOM 27 CATHETER. THE BROKEN SEGMENT WAS RETRIEVED BY A CATHETER. THE PHYSICIAN WAS ABLE REMOVE ALL OF THE PIECES OF THE DELIVERY SYSTEM. A SECOND DEVICE WAS OPENED AND SUCCESSFULLY IMPLANTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED THAT THE BROKEN PUSHER WIRE WAS REMOVED WITH GOOD RESULTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17715537 ↗
• MalfunctionDec 7, 2022Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932028 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED ACUTE INFARCT OF THE LEFT PERIVENTRICULAR REGION AND LEFT BASAL GANGLIA WITH RIGHT SIDED WEAKNESS AND ATAXIA. SAFETY ASSESSED STROKE. IT WAS NOTED THAT THE PATIENT WAS TREATED WITH ANTIPLATELET THERAPY WITH ASPIRIN AND PLAVIX. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION AND STUDY DEVICE, AND RELATEDNESS TO THE STUDY PROCEDURE AS PROBABLE. THE OUTCOME STATUS WAS RECOVERED/RESOLVED ON (B)(6) 2022.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA; Unspecified Nervous System Problem

  MAUDE report 15883461 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD SEVERE, INTERMITTENT LEFT-SIDED HEADACHE 8/10 WITH ASSOCIATED NAUSEA, VOMITING AND LIGHTHEADEDNESS. THE ADVERSE EVENT RESULTED IN TREATMENT. THE CT SCAN WAS UNREMARKABLE. PER PI, THE HEADACHE WAS RELATED TO RECURRENT HERPES LABEALIS AS SYMPTOMS IMPROVED BY TAKING ACYCLOVIR. OUTCOME STATUS IS RECOVERED/RESOLVED.

  Patient problems: Dizziness; Headache; Nausea; Vomiting

  MAUDE report 15663353 ↗
• MalfunctionSep 16, 2022Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. PIPELINE SHIELD DEVICE PREPARED PER INSTRUCTIONS FOR USE (IFU). DURING THE DEPLOYMENT, THE TIP COIL WOULD NOT ADVANCE PAST THE M2 BIFURCATION IN ORDER TO GET ENOUGH DEVICE OUT AND THAN SUBSEQUENTLY DRAG/DROP PROXIMAL TO RIGHT ANTERIOR TEMPORAL ARTERY (IN M1). WE NEEDED MORE DISTAL COVERAGE AND JAIL THE A1 JUST BASED ON WHERE THE ANEURYSM WAS LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). WE PUSHED DELIVERY WIRE BUT IT WOULDN¿T TRAVEL DISTALLY. THE SYSTEM CAME BACK TOO FAR (INTO ICA-TERMINUS) BEFORE FULLY APPOSING SO TRIED TO RECAPTURE AND ADVANCE (SAVING THE DEVICE). DURING REDEPLOYMENT, THE DEVICE APPEARED TO HAVE INVAGINATED THE DISTAL WIRE AND WOULDN¿T PROPERLY OPEN SO WE RECAPTURED AND WENT WITH A NEW DEVICE. WE ALSO ADDED A PHENOM PLUS FOR ADDITIONAL SUPPORT. ALL WENT WELL WITH THE SECOND DEVICE. THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. MULTIPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15435258 ↗
• MalfunctionJun 15, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO DEPLOY IN THE CATHETER AND BEGAN TO DROP INTO THE SEVERE TURNS. THE PIPELINE WOULD NOT PUSH OUT OF THE CATHETER. AFTER ATTEMPTING TO DEPLOY, THE PHENOM27 AN DEVICE WERE REMOVED. OUTSIDE OF THE PATIENT'S BODY, THE PIPELINE COULD NOT BE REMOVED FROM THE CATHETER. THE PIPELINE WAS STUCK AT THE DISTAL END. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE ISSUE DID NOT RESOLVE. THE CATHETER NOR THE PUSHWIRE WERE DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 9MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. A DAPT WAS ADMINISTERED AND THE PRU LEVEL WAS 120. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED GOOD RESULTS WITH THE NEW DEVICE IMPLANTED. ANCILLARY DEVICES INCLUDE 6FR SHUTTLE SHEATH, NAVIEN 058 AND PHENOM PLUS GUIDE CATHETERS, PHENOM 27 MICROCATHETER, AND FATHOM GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706414 ↗
• MalfunctionJun 6, 2022Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT UPON OBTAINING ACCESS INTO THE RIGHT ICA WITH A TRIAXIAL APPROACH OF THE PHENOM 27 MICROCATHETER IN THE RIGHT MCA, THE PHENOM PLUS POSITIONED DISTALLY TO THE HORIZONTAL PETRUS AND THE 7FR RIST AT THE LEVEL OF THE HORIZONTAL PETRUS (RIGHT ICA), THE PIPELINE SHIELD WAS PREPPED PER FDA INSTRUCTIONS AND DELIVERED INTO THE PHENOM 27 MICROCATHETER WITH MODERATE TORTUOSITY. THE PIPELINE WAS SLIGHTLY OPENED IN THE RIGHT MCA THEN DRAGGED INTO POSITION OF THE RIGHT SUPRACLINOID ANEURYSM JUST DISTAL TO THE RIGHT PCOMM BUT DURING DELIVERY THE PIPELINE SLIPPED OUT OF POSITION. THE PHYSICIAN CORRECTLY TRIED TO RESHEATH THE PIPELINE TO REPOSITION MORE DISTALLY BUT THE PIPELINE CAME OFF THE DISTAL BUMPER AND THEY LOST CONTROL OF RESHEATHING THE PIPELINE AND WITH ABOUT 60% OF THE PIPELINE STILL INSIDE THE PHENOM 27, THEY WERE ABLE TO COMPLETELY REMOVE THE PIPELINE BY REMOVING THE PHENOM 27 WITH NO COMPLICATIONS TO THE PATIENT. A NEW PHENOM 27 AND PIPELINE WERE PREPPED PER FDA INSTRUCTIONS WITH THE SAME SCENARIO AS BEFORE OCCURRING, THE PIPELINE MISPOSITIONED OVER THE ANEURYSM AND THE PIPELINE CAME OFF THE BUMPER WHILE ATTEMPTING TO RESHEATH. A THIRD PHENOM 27 AND PI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606067 ↗
• MalfunctionJun 6, 2022Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT UPON OBTAINING ACCESS INTO THE RIGHT ICA WITH A TRIAXIAL APPROACH OF THE PHENOM 27 MICROCATHETER IN THE RIGHT MCA, THE PHENOM PLUS POSITIONED DISTALLY TO THE HORIZONTAL PETRUS AND THE 7FR RIST AT THE LEVEL OF THE HORIZONTAL PETRUS (RIGHT ICA), THE PIPELINE SHIELD WAS PREPPED PER FDA INSTRUCTIONS AND DELIVERED INTO THE PHENOM 27 MICROCATHETER WITH MODERATE TORTUOSITY. THE PIPELINE WAS SLIGHTLY OPENED IN THE RIGHT MCA THEN DRAGGED INTO POSITION OF THE RIGHT SUPRACLINOID ANEURYSM JUST DISTAL TO THE RIGHT PCOMM BUT DURING DELIVERY THE PIPELINE SLIPPED OUT OF POSITION. THE PHYSICIAN CORRECTLY TRIED TO RESHEATH THE PIPELINE TO REPOSITION MORE DISTALLY BUT THE PIPELINE CAME OFF THE DISTAL BUMPER AND THEY LOST CONTROL OF RESHEATHING THE PIPELINE AND WITH ABOUT 60% OF THE PIPELINE STILL INSIDE THE PHENOM 27, THEY WERE ABLE TO COMPLETELY REMOVE THE PIPELINE BY REMOVING THE PHENOM 27 WITH NO COMPLICATIONS TO THE PATIENT. A NEW PHENOM 27 AND PIPELINE WERE PREPPED PER FDA INSTRUCTIONS WITH THE SAME SCENARIO AS BEFORE OCCURRING, THE PIPELINE MISPOSITIONED OVER THE ANEURYSM AND THE PIPELINE CAME OFF THE BUMPER WHILE ATTEMPTING TO RESHEATH. A THIRD PHENOM 27 AND PI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606022 ↗
• MalfunctionDec 7, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE HAD RESISTANCE AND BECAME STUCK IN THE DISTAL SECTION OF TA PHENOM CATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RIGHT PARACLINOID SACCULAR ANEURISM. THE MAX DIAMETER WAS 7 MM AND THE NECK DIAMETER WAS 3.5 MM. THE DISTAL LANDING ZONE WAS 3.2 MM AND THE PROXIMAL WAS 3.8. VESSEL TORTUOSITY WAS NORMAL. ACCESS VESSEL WAS THE RIGHT CAROTID. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS STASIS IN THE ANEURYSM. WHILE PUSHING THE PIPELINE HAD SOME RESISTANCE AND ONCE THE DEVICE GOT TO THE DISTAL PHENOM THE DEVICE WOULD NOT ADVANCE AND THE PIPELINE SHIELD AND PHENOM WERE PULLED OUT TOGETHER. THE PIPELINE BECAME STUCK AND LOCKED UP. CONTINUOUS FLUSH WITH HEPARINIZED SALINE WAS USED. THE PHYSICIAN RELEASED THE LOAD IN AN ATTEMPT TO RESOLVE THE ISSUE. IT DID NOT RESOLVE THE ISSUE. THE PROXIMAL SECTION OF THE PIPELINE WAS DAMAGED AS IT WAS SLIGHTLY BENT.  NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: SHEATH, NAVIEN 058 GUIDE CATHETER, SYNCHRO 014

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957791 ↗
• DeathNov 16, 2021Activation, 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 RECEIVED REPORTED THAT A BALLOON WAS USED TO COMPLETELY OPEN THE DEVICE DURING THE PROCEDURE. DEPLOYMENT WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED HOME THE NEXT DAY.

  Patient problems: Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 12821058 ↗

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, 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-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-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-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-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