PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00763000284541), received between Aug 10, 2021 and Jan 30, 2026 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (26 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD EMBOLIZATION DEVICE STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) C4 SEGMENT UNRUPTURED AMORPHOUS ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 6.3MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AND DELIVERED TO THE MIDDLE CEREBRAL ARTERY (MCA) STRAIGHT SEGMENT. DURING DEPLOYMENT, IT WAS OBSERVED THAT THE DISTAL END OF THE PIPELINE STENT DID NOT OPEN. FURTHER ATTEMPT TO REDEPLOY, PUSH AND PULL, WERE UNSUCCESSFUL AS THE DISTAL END REMAINED UNOPENED. THE PIPELINE WAS REMOVED AND DAMAGE TO THE DISTAL END MESH WAS OBSERVED. THEREFORE THE PIPELINE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: 8F GUIDING SHEATH, NAVIEN 6F 115CM CATHETER, STRYKER XT-27 MICROCATHETER, STRYKER SYNCHRO GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221496 ↗
• MalfunctionDec 23, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE PIPELINE'S FAILURE TO OPEN AND PHENOM CATHETER DAMAGE WAS ASKED BUT UNKNOWN. THE SECTION OF THE PIPELINE THAT DID NOT OPEN WAS THE DISTAL TIP. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE INCLUDED MULTIPLE ATTEMPTS TO RETRIEVE AND REDEPLOY IS STILL COULD NOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879298 ↗
• MalfunctionDec 15, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS DETERMINED TO BE RESISTANCE, WHICH OCCURRED IN THE DISTAL SECTION OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE, SUCH AS KINKING, STRETCHING, OR SEPARATION, WAS OBSERVED ON THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805048 ↗
• MalfunctionOct 24, 2025Positioning Failure; Retraction Problem; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Retraction Problem; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE DIFFICULTIES IN STENT POSITIONING, FAILURE TO OPEN, AND RESISTANCE AT THE HUB WERE NOT DETERMINED. ONLY ONE PIPELINE WAS BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. OTHER THAN BEING STUCK AT HUB, THERE WAS NO RESISTANCE DURING RESHEATHING OR RETRIEVAL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE DEPLOYMENT PROCESS INVOLVED WITHDRAWING THE MICROCATHETER, WITH THE TIP OF THE MICROCATHETER REMAINING IN A DYNAMIC POSITION THROUGHOUT. IT WAS STATED THE SURGERY WAS ULTIMATELY DELAYED, AND ONLY THE CONTRALATERAL ANEURYSM WAS TREATED IN THIS INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386160 ↗
• MalfunctionOct 15, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM OF THE OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. NEUROIN TERVENTION WAS PERFORMED WITH IMPLANTATION OF A DENSE MESH FLOW-DIVERTING STENT. FEMORAL ARTERY PUNCTURE WAS PERFORMED, AND A 6F LONG SHEATH WAS SUCCESSFULLY ADVANCED TO THE COMMON CAROTID ARTERY WITH THE ASSISTANCE OF A 0.035-INCH LOACH GUIDEWIRE AND A 125 CM MUL TIFUNCTIONAL ANGIOGRAPHIC CATHETER. THE INTERMEDIATE CATHETER WAS THEN ADVANCED TO THE CAVERNOUS SEGMENT, AND THE PHENOM27, GUIDED BY A 0.014-INCH SYNCHRO, WAS SMOOTHLY NAVIGATED TO THE IPSILATERAL M1 SEGMENT. BASED ON 3D MEASUREMENTS, A PED SHIELD-450-20 MODEL STENT WAS SELECTED. AFTER ADEQUATE HYDRATION WITH HIGH-PRESSURE NORMAL SALINE, THE STENT WAS SMOOTHLY DELIVERED TO THE IPSILATERAL M1 SEGMENT. THE STENT TIP WAS DEPLOYED, BUT IT COULD NOT BE OPENED IN THE MIDDLE CEREBRAL ARTERY; EVEN AFTER ABOUT 15 CM HAD BEEN DEPLOYED, IT STILL COULD NOT OPEN. THE STENT WAS THEN RETRIEVED AND PULLED BACK TO THE INTERNAL CAROTID ARTERY, WHERE THE PED SHIELD TIP OPENED SLIGHTLY, BUT NOT FULLY. MORE OF THE STENT WAS RELEASED, AND A SERIES OF STANDARD MANEUVERS SUCH AS SLIGHT MANIPULATION WERE PERFORMED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302751 ↗
• MalfunctionSep 12, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043979 ↗
• MalfunctionAug 4, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED A TOTAL OF TWO PIPELINES AND TWO MARKSMAN 150S FAILED TO OPEN. THE THIRD ONE DID NOT EXPERIENCE ISSUES AND WAS DEPLOYED NORMALLY. THE THIRD ONE USED A PHENOM 27 MICROCATHETER. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709969 ↗
• MalfunctionJul 22, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED, SUSPECTED THAT IT WAS STENT TIP END DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564889 ↗
• MalfunctionMay 23, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE STENT IS STUCK IN THE CATHETER AND CANNOT BE SEPARATED, SO THERE WERE SENT BACK TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079909 ↗
• MalfunctionApr 28, 2025Structural Problem; Material Twisted/Bent; Activation Failure; Structural Problem; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 4 PIPELINES WOULD NOT OPEN DURING DEPLOYMENT. THERE WERE MULTIPLE TIMES THE DISTAL END WOULD NOT BE OPEN. THEN THE OPERATOR WAS ABLE TO GET THE DISTAL END OPEN BUT THE MIDDLE AND PROXIMAL SEGMENTS WERE RIBBONED AND NOT OPEN. EVENTUALLY THE PHYSICIAN ABORTED THE PROCEDURE AND NO DEVICE WAS IMPLANTED. THE PIPELINES WERE POSITIONED IN A BEND IN THE PROXIMAL, MIDDLE AND DISTAL SECTIONS. MORE THAN 50% OF THE 4 PIPELINES HAD BEEN DEPLOYED WHEN THEY FAILED TO OPEN. THE PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINES. THE DEVICES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINES WERE USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT CAVERNOUS ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.7MM AND PROXIMAL: 4.5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921094 ↗
• MalfunctionApr 2, 2025Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MARKSMAN CATHETER AND PHENOM CATHETER ENCOUNTERED RESISTANCE WITH A STENT AND WERE BOTH FOUND DAMAGED. THE PATIENT WAS UNDERGOING ANEURYSM TREATMENT. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 10 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE BLOOD VESSELS WERE TORTUOUS, AND WHEN THE MARKSMAN WAS RAISED, A LOT OF RESISTANCE WAS FELT, MAKING IT DIFFICULT TO DELIVER THE STENT FORWARD. AFTER TORQUE CONTROL, CONTINUED TO DELIVER IT UPWARD. IT WAS FELT THAT THE MARKSMAN WAS FLACCID AND COULD NOT BE PUSHED FORWARD. WHEN WITHDRAWING IT, IT WAS FOUND THAT THE FRONT END OF THE CATHETER WAS DAMAGED. AFTER CHANGING TO P27, IT WAS SMOOTHLY IN PLACE. THE STENT WAS DIFFICULT TO OPEN WHEN DEPLOYED. AFTER RETRIEVING IT, IT WAS PUT IN PLACE AGAIN TO DEPLOY THE STENT. THE STENT FELL OFF TWICE DUE TO INSUFFICIENT ANCHORING. AFTER REPEATED RETRIEVING TWICE, OBVIOUSLY FELT THAT THE SUPPORT FORCE OF THE CATHETER WAS INSUFFICIENT. IT WAS SUSPECTED THAT THE FRONT END OF THE CATHETER WAS DAMAGED, SO IT WAS WITHDRAWN AND THE FRONT END WAS FOUND TO BE KINKED. THE PROBLEM WAS SOLVED AFTER REPLACING IT WITH A NEW P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758638 ↗
• MalfunctionMar 14, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE PIPELINE FAILING TO OPEN WAS NOT DETERMINED. THE PIPELINE HAD BEEN PLACED IN A STRAIGHT SECTION WHEN IT FAILED TO OPEN. THE PIPELINE WAS RETRIEVED AND DEPLOYED AGAIN TO ATTEMPT TO OPEN. THERE ANY ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE. THERE WERE NO ISSUES WITH THE PHENOM CATHETER BESIDES THE PIPELINE FAILURE TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609495 ↗
• MalfunctionDec 30, 2024Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036424 ↗
• MalfunctionDec 26, 2024Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PUSHWIRE LOOKED "ROUGH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021740 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO ADDITIONAL TREATMENT OR INTERVENTION REQUIRED FOR THE REPORTED BRUISING AND HAIR LOSS. IT WAS NOTED THAT REGARDING THE PATIENT REPORTED HAIR LOSS, "PER SOURCE DOCUMENT STATES THAT IT CAN BE FROM RADIATION DURING ANGIO." ADDITIONALLY, BRUISING MAY BE ASSOCIATED WITH ANTIPLATELET MEDICATIONS. HAIR LOSS AND BRUISING WAS NOT CONFIRMED FOR THIS PATIENT.

  Patient problems: Blurred Vision; Bruise/Contusion; Flashers; Hair Loss; Headache; Loss of Vision; Paresthesia; Vitreous Floaters

  MAUDE report 20578968 ↗
• MalfunctionOct 24, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM27 CATHETER WAS GUIDED OVER THE NERVE GUIDEWIRE AND THE HEALTHCARE PROVIDER (HCP) PUSHED IT TO GO UPPER TO THE MIDDLE CEREBRAL ARTERY M1. AFTER THE PED2-45-20 DENSE MESH STENT WAS FULLY HYDRATED, DELIVERY VIA PHENOM27 BEGAN. WHEN THE STENT JUST ENTERED THE PHENOM27, THE SURGEON REPORTED THAT THE RESISTANCE WAS LARGE. THE CATHETER REDUCED TENSION AND SLOWLY DELIVERED THE IT TO PLACE. STABILIZED THE STENT AND PUSHED THE GUIDEWIRE, AND WITHDREW THE CATHETER AND STARTED DEPLOYING THE STENT TIP. WHEN THE STENT WAS EXPOSED FOR ABOUT 8 MM, THE TIP END WAS STILL NOT OPENED, AND THE WHOLE STENT WAS WITHDRAWN TO THE INTERNAL CAROTID ARTERY, WHICH STILL COULD NOT SOLVE THE PROBLEM. THEN, PUSHED THE  INTERMEDIATE CATHETER TO GO UPPER AND THE STENT WAS RETRIEVED. THE STENT TIP WAS DEPLOYED AGAIN, AND PUSHED, PULLED, AND SWUNG. THE STENT TIP STILL DID NOT OPEN PROPERLY AND COULD NOT BE DEPLOYED FURTHER, SO IT WAS WITHDRAWN FROM THE BODY AS A WHOLE. THE OPERATION WAS SUCCESSFULLY COMPLETED BY REPLACING WITH THE NEW PHENOM27 CATHETER AND PED2-450-18 STENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523585 ↗
• MalfunctionJul 24, 2024Unintended Ejection; Device Dislodged or Dislocated; Physical Resistance/Sticking; Unintended Ejection; Device Dislodged or Dislocated; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SURGERY WAS CHANGED TO ORDINARY STENT EMBOLIZATION, WHICH INCREASED THE SURGICAL RISK MORE THAN PLANNED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THERE WAS NO FRICTION/RESISTANCE DURING RESHEATHING OR RETRIEVAL OF THE PIPELINE.

  Patient problems: Failure of Implant

  MAUDE report 19817880 ↗
• InjuryJul 16, 2024Structural Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS DISCHARGED ON (B)(6) 2024. NCCT, CTA, AND MR TAKEN DURING THIS HOSPITALIZATION. IMAGING REPORTED IVH WITHIN THE RIGHT LATERAL VENTRICLE. THE VENTRICLES ARE NORMAL IN SIZE AND MORPHOLOGY WITHOUT HYDROCEPHALUS. NO MASS EFFECT OR MIDLINE SHIFT. PATENT FLOW CONTRAST THROUGHOUT THE DEVICE AND INTO THE RIGHT MCA. DEVICE WAS IMPLANTED. ADDITIONAL FINDINGS OF SEVERE STENT STENOSIS WITH PATENT FLOW.

  Patient problems: Headache; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Stenosis

  MAUDE report 19755002 ↗
• MalfunctionApr 11, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM 27 NAVIGATED INTO M1 WITH GREAT DIFFICULTY DUE TO SIZE OF ANEURYSM AND SEVERE TORTUOSITY. DEVICE WAS PREPPED AND TAKEN INTO THE M1 WHERE THE DOCTOR ATTEMPTED TO OPEN THE DISTAL DEVICE. RECAPTURE, DIFFERENT LOCATIONS AND HEAVY LOAD WERE ATTEMPTED TO OPEN THE DEVICE DISTALLY. IT REMAINED CONSTRAINED THROUGHOUT ALL EFFORTS IN THE DISTAL END. THE PIPELINE WAS NOT POSITIONED IN A BEND, MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, IT WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN. DEVICE RESHEATHED AND PHENOM WERE REMOVED FROM THE BODY. PIPELINE DEPLOYED ON BACKTABLE AND THE DISTAL END REMAINED CONSTRAINED OUTSIDE OF THE BODY. PHYSICIAN OPTED TO END THE PROCEDURE AND BRING PATIENT BACK TO USE VANTAGE FOR MORE RELIABLE DISTAL OPENING WHEN DEVICE APPROVED AT THIS FACILITY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTI

  Patient problems: Failure of Implant

  MAUDE report 19087184 ↗
• MalfunctionJan 9, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THERE SHOULD NOT BE MANY PROBLEMS WITH VISUAL INSPECTIONS OF THE PHENOM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475448 ↗
• MalfunctionOct 3, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS LAZY TO OPEN AROUND A TURN AT THE DISTAL END. MULTIPLE ATTEMPTS WERE MADE TO RESOLVE THE ISSUE WITHOUT SUCCESS. THE PIPELINE WAS REMOVED AND REPLACED WITH ANOTHER PIPELINE. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE PART. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (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 8MM AND A 4MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 4.0MM DISTALLY AND 4.2MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED GOOD APPOSITION AND SOME CONTRAST STAGNATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861351 ↗
• MalfunctionSep 29, 2023Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE SLIPPED BACK TOP PROXIMAL, HEALTHCARE PROVIDER (HCP) RESHEATHED THE DEVICE, THE TIP COIL WAS GETTING CAUGHT ON MIDDLE CEREBRAL ARTERY (MCA) PERFORATOR. HCP TRIED TO MANIPULATE THE MICROCATHETER AND THE TIP COIL TO GET AROUND PERFORATOR UNSUCCESSFULLY. THE DECISION WAS MADE TO REMOVE THE DEVICE. THERE WAS MOVEMENT DURING PLACEMENT (DIFFICULT PLACEMENT/POSITIONING.) MULTIPLE PIPELINE DEVICES WERE NOT BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION. THE PIPELINE MISSED THE LANDING ZONE. THERE WERE NO ADDITIONAL STEPS REQUIRED TO REMOVE OR SECURE THE PIPELINE. THE DEVICE JUMPED DURING DEPLOYMENT. THE PIPELINE WAS PLACED AT 3MM PAST THE ANEURYSM NECK ON EACH SIDE. NO SIDE BRANCHES WERE COVERED BY PIPELINE. THE TIP OF THE CATHETER MOVED DURING DEPLOYMENT. 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 OPTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848030 ↗
• MalfunctionJul 20, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE STENT WAS HALF DEPLOYED AND COULD NOT BE OPENED. THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PROXIMAL SECTION OF THE DEVICE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 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 INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED 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 C4 ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A 3MM NECK DIAMETER. THE LANDING ZONE WAS 4.0MM DISTALLY AND 4.6MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368148 ↗
• MalfunctionMay 22, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE'S FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 9 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.8 MM DISTALLY AND 4.3 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 125. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SUCCESSFUL FLOW DIVERSION. IT WAS REPORTED THAT THE PHYSICIAN DISCARDED 2 PIPELINES BECAUSE WASN'T COMFORTABLE DEPLOYING IN THAT LOCATION. PIPELINES FISH MOUTHED SLIGHTLY IN PATIENT BUT OPENED AS NORMAL ON BACK TABLE. PHYSICIAN REPLACED WITH 2 PIPELINES FROM MY TRUNK STOCK THAT DEPLOYED SUCCESSFULLY. IT WAS REPORTED BOTH OF THE PIPELINES FAILED TO OPEN IN THE DISTAL SECTION. 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 REMOVED FROM THE PATIENT BY RESHEATHING AND REMOVING WITH T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973918 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT A PATIENT HAD A DELAYED INTRACRANIAL HEMORRHAGE (ICH). NO OTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS STABLE AT THE TIME OF THE REPORT. THE PATIENT WAS BEING TREATED FOR A LARGE IRREGULAR ANEURYSM, BILOBED ON BOTH SIDES OF CAVERNOUS INTERNAL CAROTID ARTERY 13X9MM AND 6X5MM. THE VESSEL TORTUOSITY WAS SEVERE. THE PATIENT IS RECOVERING FROM THE PROCEDURE WELL. THE PATIENT EXPERIENCED A HEADACHE RELATED TO THE INTRACRANIAL HEMORRHAGE. THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THERE WAS NO DEVICE MALFUNCTION OR DEFICIENCY ASSOCIATED WITH THE EVENT.

  Patient problems: Headache; Intracranial Hemorrhage

  MAUDE report 16593041 ↗

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-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