PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000284527), received between Jul 19, 2021 and Feb 16, 2026 — classified as 1 death, 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT OPHTHALMIC SEGMENT. THE LANDING ZONE (ARTERY SIZE) WAS 4.0MM DISTALLY AND 4.4MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 170. THE ANGIOGRAPHIC POST PROCEDURE RESULT WAS RETENTION OF CONTRAST AGENT WITHIN THE ANEURYSM, WHILE BLOOD FLOW IN THE PARENT ARTERY AND DISTAL VESSELS WAS NORMAL. IT WAS REPORTED THAT THE PHENOM27 SHAPABLE MICROCATHETER WAS PLACED TO THE LEFT M2 SEGMENT. BASED ON THE VESSEL DIAMETER AT THE ANEURYSM SITE, A 4.5-16 STENT WAS SELECTED; BOTH THE INNER AND OUTER PACKAGING WERE INTACT. THE FLOW-DIVERTING MESH STENT WAS HYDRATED AND THEN WAS DELIVERED THROUGH THE PHENOM27. AFTER POSITIONING THE STENT, MULTIPLE ATTEMPTS WERE MADE TO DEPLOY THE STENT, BUT THE STENT TIP COULD NOT BE OPENED AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS THEN REMOVED AND REPLACED WITH A 4.5-14 STENT, WHICH WAS DEPLOYED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343967 ↗
• MalfunctionJan 26, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER CATHETERIZATION, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2) WAS REMOVED FROM PACKAGING ACCORDING TO STANDARD PROCEDURE, FULLY HYDRATED, AND DELIVERED TO THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY. ATTEMPTS WERE MADE TO OPEN THE PED2 BY RETRACTING THE PHENOM 27 MICROCATHETER; THE PHENOM 27 WAS RETRACTED AND PED2 WAS DEPLOYED, BUT IT WAS FOUND THAT THE TIP OF THE PED2 DID NOT OPEN. AFTER CONTINUED DEPLOYMENT AND REPEATED PUSHING AND PULLING, THE TIP STILL DID NOT OPEN. THE ENTIRE SYSTEM WAS THEN RETRACTED BACK INTO THE PHENOM 27, AND REPOSITIONED TO THE ORIGINAL SITE AT THE PROXIMAL END OF THE POSTERIOR COMMUNICATING ARTERY AND DEPLOYED. THE DELIVERY WIRE WAS PUSHED, BUT THE TIP OF THE PED2 STILL DID NOT OPEN. THE ENTIRE PED2 AND PHENOM 27 SYSTEM WAS WITHDRAWN FROM THE BODY. THE PRODUCTS WERE REPLACED WITH A NEW PHENOM 27 AND PIPELINE STENT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, INTERNAL CAROTID ARTERY (ICA) C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.2 MM AND A 4.6 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179438 ↗
• MalfunctionAug 21, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX STENT FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM IN THE RIGHT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE WAS 4.01 MM DISTALLY AND 4.49 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT ) WAS ADMINISTERED AND THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS 92. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE SUCCESSFUL DEPLOYMENT OF THE REPLACEMENT PIPELINE STENT. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE MIDDLE SECTION OF THE 4.5X16 PIPELINE STENT DID NOT OPEN WHEN THE MIDDLE SECTION WAS POSITIONED IN A BEND AND DEPLOYED MORE THAN 50%. THE DEVICE HAD A KINK RIGHT AROUND THE TURN OF THE ANTERIOR GENU. THE STENT WAS LOADED AND UNLOADED AND ATTEMPTED TO RECAPTURE AND REDUCE THE LOAD OF THE PHENOM 27 MICROCATHETER TO DEPLOY THE STENT WITHIN THE INNER CURVE OF THE ANTERIOR GENU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864312 ↗
• MalfunctionJul 22, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE TIP END WAS NOT OPENED, AND THE CUSTOMER DARED NOT TO PERFORM POST-PROCESSING. IT WAS CLARIFIED THAT THE ROUGH TIP OF THE STENT WAS OBSERVED AFTER RETRIEVING, SAW IT UNDER PERSPECTIVE. IT WAS UNKNOWN IF ANY RESISTANCE WAS FELT DURING THE INITIAL DELIVERY OR RE-RETRIEVAL ATTEMPTS. THE MICROCATHETER DID NOT APPEAR DAMAGED, KINKED, OR OBSTRUCTED AFTER THE PROCEDURE. THE CATHETER WAS A PHENOM27, LOT NUMBER WAS UNKNOWN. THE STENT WAS FLUSHED AND HYDRATED ACCORDING TO THE IFU BEFORE USE. THERE WAS NO DAMAGE TO THE INTRODUCER SHEATH OR DELIVERY SYSTEM, BUT THE DELIVERY SYSTEM WAS DISCARDED, LEAVING ONLY A STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566354 ↗
• MalfunctionDec 6, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING A PIPELINE EMBOLIZATION DEVICE, THERE WERE SEVERAL ISSUES. THE PROCEDURE INVOLVED TREATING AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY WITH A MAXIMUM DIAMETER OF 6 MILLIMETERS AND A NECK DIAMETER OF 4 MILLIMETERS. LANDING ZONE: DISTAL: 4.5 MM AND PROXIMAL: 4.2 MM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY. THE DEVICE WAS DELIVERED THROUGH A PHENOM 27 CATHETER. AFTER THE STENT WAS PUSHED OUT OF THE CATHETER, THE TIP END COULD NOT BE OPENED, EVEN AFTER REPEATED RETRIEVAL ATTEMPTS. SUBSEQUENTLY, THE STENT WAS RETRIEVED AND REMOVED FROM THE BODY, BUT IT BECAME STUCK AT THE PROXIMAL END OF THE CATHETER AND COULD NOT BE REMOVED. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ACCESS VESSEL WAS THE FEMORAL ARTERY. THE VESSEL TORTUOSITY WAS MODERATE. A NEW SYSTEM AND CATHETER WERE USED TO COMPLETE THE OPERATION. THE ANGIOGRAPHIC RESULT POST-PROCEDURE INDICATED BLOOD RETENTION IN THE ANEURYSM. THE INITIAL SYSTEM WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867295 ↗
• DeathOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ADVERSE EVENT WAS NOT THE RESULT OF A DEVICE DEFICIENCY. THE SITE ASSESSED THE EVENT AS NOT RELATED TO A RETREATMENT PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Ischemia Stroke; Numbness; Syncope/Fainting; Thrombosis/Thrombus

  MAUDE report 20575611 ↗
• InjuryOct 1, 2024Activation, 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 THE PATIENT EXPERIENCED FLU-LIKE SYMPTOMS AND DIZZINESS STARTING (B)(6) 2025. THE PATIENT HAD A FALL AND STRUCK HER HEAD DUE TO THESE SYMPTOMS AND WENT TO THE HOSPITAL EMERGENCY DEPARTMENT WHERE SHE RECEIVED IV BOLUS FLUIDS, MORPHINE, AND ZOFRAN WITH STATUS/OUTCOME REPORTED AS "RECOVERING/RESOLVING"; THERE WAS NO INDICATING THATTHE PATIENT WAS ADMITTED AS THE REPORT INDICATED SHE WAS NOT HOSPITALIZED. THE EVENT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY OR ADDITIONAL INTERVENTION. IT SHOULD BE NOTED THAT THE PATIENT HAD SYMPTOMS OF DIZZINESS AND HEADACHE AT BASELINE. THE SITE ASSESSMENT CONCLUDED THE EVENT WAS NOT RELATED TO THE PROCEDURE OR DEVICES. THE EVENT WAS REPORTED BY THE STUDY TEAM CONSERVATIVELY.

  Patient problems: Chest Pain; Diplopia/Double Vision; Dizziness; Headache; Ischemia Stroke; Paresthesia; Tachycardia

  MAUDE report 20347614 ↗
• MalfunctionSep 26, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C6 SEGMENT WITH A MAX DIAMETER OF 5.8 MM AND A 4.2 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.3 MM AND PROXIMAL: 4.6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED VASCULAR PATENCY. IT WAS REPORTED THAT WHEN USING DENSE MESH STENT TO TREAT ANEURYSM, CHOSE A PED2-450-16 STENT, BUT FOUND THAT THE TIP END COULD NOT BE OPENED. AFTER MULTIPLE ATTEMPTS, THE STENT STILL COULD NOT BE OPENED. REPLACED IT WITH A PED2-450-18 STENT, WHICH OPENED WELL AND THE OPERATION WENT SMOOTHLY. THE PIPELINE WAS NOT USED FOR AN INDICATED THAT IS OFF-LABEL. THE REPORTED DEVICE 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 20310545 ↗
• MalfunctionApr 23, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE STENT FAILED TO OPEN IN THE DISTAL SECTION. THE PHYSICIAN WENT TO DEPLOY THE DEVICE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND COULD NOT GET THE DEVICE TO OPEN AFTER SEVERAL MANEUVERS TO FACILITY OPENING. THEIR WAS AN ACUTE TURN AT THE ORIGIN OF THE COMMON CAROTID ARTERY AS WELL AS TONSULAR LOOP IN THE INTERNAL CAROTID ARTERY (ICA). THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM 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 SACCUALR ANEURYSM IN THE LEFT ICA. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL LANDING ZONE WAS 4.5MM. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: TERUMO 8 F SHEATH, BALLAST AND PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169835 ↗
• MalfunctionMar 14, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE STENT COULD NOT BE OPENED DISTALLY. THE PIPELINE WAS NOT IN THE CURVED SECTION OF THE VESSEL, BUT IN THE STRAIGHT SECTION WHEN IT FAILED TO OPEN. THERE WAS NO NEED FOR ANY ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902780 ↗
• MalfunctionDec 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT A KINK WAS OBSERVED AFTER THE PUSH GUIDEWIRE WAS TAKEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268951 ↗
• MalfunctionOct 30, 2023Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT UPON INITIAL DELIVERY, THE PED WAS NOTICED TO HAVE A NARROWING AT THE DISTAL 1/3. MULTIPLE ATTEMPTS WERE MADE TO RE-CAPTURE AND RESOLVE, BUT WITHOUT SUCCESS. THE DEVICE WAS REMOVED AND ANOTHER PED (SAME SIZE) WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS FAILURE TO OPEN IN THE DISTAL PORTION. THE MIDDLE PORTION OF THE PIPELINE WAS POSITIONED IN A DISTAL BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINE WAS USED FOR AN APPROVED 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX D IAMETER OF 7MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 4MM DISTALLY AND 4.3MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031015 ↗
• MalfunctionMay 1, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. THE LANDING ZONE WAS 3.14MM DISTALLY AND 4.54MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, PRU LEVEL WAS 85. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE DOCTOR HAD A PIPELINE DEVICE THAT FAILED TO OPEN ON THE DISTAL END DURING A PROCEDURE. THE PATIENT WAS PREPPED AND RIGHT RADIAL ARTERY ACCESSED WITH WAHOO CATHETER. WAHOO ADVANCED INTO RIGHT INTERNAL CAROTID ARTERY. THE PHENOM 027 WAS THEN ADVANCED INTO THE RIGHT MCA OVER AN ARISTOTLE 018 WIRE. THE PIPELINE WAS FLUSHED AND PREPPED PER IFU. THE PIPELINE WAS ADVANCED INTO THE PHENOM UNTIL THE DEVICE WAS IN THE DISTAL CATHETER. THE PHENOM WAS THEN PULLED BACK INTO THE RIGHT ICA AND THE DEVICE ADVANCED AND DEPLOYMENT WAS ATTEMPTED. DURING DEPLOYMENT, THE DISTAL BRAID OF THE DEVICE WOULD NOT OPEN. THE MID SEGMENT OF THE PIPELINE OPENED APPROPRIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844220 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED LESION CHARACTERISTICS: TERMINUS, LOBULATED, 12MM, RIGHT C7. THE PATIENT WAS DISCHARGED TO HOME, ALERT, FULLY ORIENTED X3, HAS A FOLLOW-UP IN A FEW WEEKS. THE PATIENT WAS GIVEN IVF, WORKED WITH PHYSICAL THERAPY, AND GIVEN SCRIPT FOR OUTPATIENT THERAPY.

  Patient problems: Headache; Muscle Weakness/Atrophy; Stroke/CVA; Thromboembolism; Transient Ischemic Attack; Unspecified Nervous System Problem

  MAUDE report 16553130 ↗
• MalfunctionDec 1, 2022Positioning Failure; Unintended Ejection; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Unintended Ejection; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT RESISTANCE OCCURRED AS THE DOCTOR WAS ATTEMPTING TO RECAPTURE THE PIPELINE DEVICE, IT DID NOT OCCUR AS HE WAS INITIALLY ATTEMPTING TO DEPLOY THE DEVICE. THE DISTAL END OF THE PIPELINE STENT APPEARED TO BE FRAYED AND NOT OPENING APPROPRIATELY. NEITHER THE PUSHWIRE OR CATHETER APPEARED TO BE KINKED OR STRETCHED. THE PUSHWIRE WAS NOT ROTATED AT ANY POINT DURING THE DEPLOYMENT OR RECAPTURE ATTEMPT. THE PUSHWIRE WAS PULLED BACK DURING THE ATTEMPT TO RESHEATH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895899 ↗
• MalfunctionJul 27, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE PARA OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.3MM DISTAL AND 4.5MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 65. IT WAS REPORTED THAT THE DOCTOR OBTAINED ACCESS INTO THE RIGHT CAROTID ARTERY WITH A BENCHMARK GUIDE CATHETER. THEY THEN ACCESSED THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH THE PHENOM 027 MICROCATHETER IN PREPARATION FOR PIPELINE DEPLOYMENT. THE DEVICE WAS ADVANCE TO THE DISTAL END OF THE MICROCATHETER, AND THEY PULLED THE PHENOM BACK INTO THE DISTAL INTERNAL CAROTID. THE DOCTOR BEGAN DEPLOYING THE DEVICE. AND DURING DEPLOYMENT THE DISTAL END OF THE PIPELINE OPENED ABOUT 25-30 PERCENT. THEY CONTINUED DEPLOYING THE DEVICE AND THE MIDDLE PORTION OF THE PIPELINE OPENED AND FULLY APPOSED THE VESSEL WALL. THEY HAD HOPED THE DISTAL END WOULD OPEN FULLY AS THEY CONTINUED WITH DEVICE DEPLOYMENT. THIS DID NOT OCCUR, SO THE DEVICE WAS RE-SHEATHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117738 ↗
• MalfunctionMay 24, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES FAILED TO OPEN DISTALLY. THE PHYSICIAN HAD ATTEMPTED TO DEPLOY MULTIPLE DEVICES, BUT THE DEVICES WOULD NOT OPEN DISTALLY DESPITE MULTIPLE ATTEMPTS OF PUSHING THE DEVICE, UNSHEATHING THE DEVICE, AND COMBINATIONS THEREOF. THE MIDDLE OF THE PIPELINES HAD BEEN POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN THE FAILED TO OPEN. THE PATIENT'S HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PATIENT RECEIVED STENT-ASSISTED COILING, AND DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. 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 ICA. THE MAX DIAMETER AND NECK DIAMETER WERE ~6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 10MM DISTAL AND 10MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489597 ↗
• MalfunctionAug 10, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES WOULD NOT OPEN FULLY AT THE DISTAL SEGMENT. THE PIPELINES WERE NOT POSITIONED IN A BEND, AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED 2 OR LESS TIMES, AND NO OTHER STEPS WERE TAKEN TO OPEN THE DEVICE. A THIRD PIPELINE WAS PLACED SUCCESSFULLY, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. 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 CAVERNOUS ICA. THE MAX DIAMETER WAS 15MM, AND THE NECK DIAMETER WAS 5MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.5MM DISTAL AND 4.3MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. ANCILLARY DEVICES INCLUDE A FUBUKI 6F GUIDE CATHETER AND A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302030 ↗
• MalfunctionJul 19, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE FAILURE TO OPEN AND SUSPECTED IT TO BE A DEVICE ISSUE AS THE SAME TECHNIQUE WAS USED WITH THE REPLACEMENT PIPELINE WHICH OPENED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189755 ↗

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-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-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