PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00763000284701), received between Jan 27, 2021 and Apr 13, 2026 — classified as 4 deaths, 1 injury, 48 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (49 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT FAILED TO OPEN IN THE DISTAL SECTION OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT C6 SEGMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE (ARTERY SIZE) WAS 4.4MM DISTAL AND 4.9MM PROXIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WHICH HAD A PLATELET REACTIVITY UNITS (PRU) OF 100. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS, "BLOOD FLOW IN THE TUMOR-FEEDING ARTERY AND DISTAL VESSELS WAS PATENT." IT WAS REPORTED THAT A PED2 500 16 FLOW DIVERTER WAS SELECTED FOR IMPLANTATION. VASCULAR ACCESS WAS ESTABLISHED USING A 6F DELIVERY CATHETER COMBINED WITH A 5F 115 CM NAVIEN CATHETER. THE PHENOM 27 STENT CATHETER WAS ADVANCED OVER A GUIDEWIRE TO THE M1 SEGMENT. AFTER THE PROTECTIVE SHEATH WAS POSITIONED FLUSH AGAINST THE HUB OF THE PHENOM 27, THE STENT WAS ADVANCED TO THE M1 SEGMENT. AFTER THE STENT CATHETER CAME OUT, AN ATTEMPT WAS MADE TO DEPLOY THE DISTAL TIP END OF THE STENT. THE DISTAL TIP END OPENED APPROXIMATELY 5 MM BUT FAILED TO FULLY OPEN. FURTHER DEPLOYMENT WAS ATTEMPTED WITHOUT SUCCESSFUL OPENING. THE STENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858034 ↗
• MalfunctionMar 12, 2026Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE RESISTANCE WAS NOT VERY OBVIOUS. THE CATHETER WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE REPORTED STATEMENT OF "ROD-LIKE" WAS CLARIFIED THAT IT REFERS TO THE FAILURE TO OPEN. THE CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN WERE NOT IDENTIFIED. THE CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE WERE NOT IDENTIFIED. THE CAUSES OR CONTRIBUTING FACTORS FOR THE BRAID DAMAGE WERE NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579666 ↗
• DeathJan 9, 2026Positioning Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT ON (B)(6) 2025, STENT FAILURE TO OPEN AND INABILITY TO PUSH A STENT TO THE DESIRED LOCATION WERE ENCOUNTERED WITH 2 PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS. THE STENTS WERE REMOVED AND REPLACED WITH A NEW STENT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027337 ↗
• MalfunctionDec 19, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PIPELINE FAILED TO OPEN AT THE DISTAL SECTION, AND WAS NOT PLACED IN A VESSEL BEND. ATTEMPTS WERE MADE TO RETRIEVE AND MANIPULATE PUSH AND PULL THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849259 ↗
• MalfunctionDec 15, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN IN THE DISTAL SECTION AND WERE FOUND ROUGH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.6 MM AND PROXIMAL: 4.9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT AFTER THE SURGEON USED THE LAST STENT, THE STENT WAS DEPLOYED SMOOTHLY AND ADHERED WELL TO THE VESSEL WALL, WITH SIGNIFICANT RETENTION OF CONTRAST AGENT. IT WAS REPORTED THAT DURING PREOPERATIVE ASSESSMENT AND DEVICE MODEL SELECTION, THE FIRST STENT CHOSEN WAS A PIPELINE 500-18. THE STENT WAS UNPACKED, HYDRATED, AND THEN DELIVERED. THE STENT DELIVERY CATHETER WAS ADVANCED TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, AND THE STENT REACHED THE TARGET POSITION AS WELL. STENT DEPLOYMENT WAS INITIATED BY RETRACTING THE DELIVERY CATHETER; THE STENT WAS IN A STRAIGHT SEGMENT OF THE VESSEL AND WAS RETRACTED 10 MM. AFTER WAITING FOR A WHILE, THE TIP OF THE STENT STILL DID NOT OPEN. THE CUSTOMER TRIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803414 ↗
• MalfunctionDec 10, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT BOTH PIPELINE DEVICES DID EXPERIENCE RESISTANCE WITH THE PHENOM DURING DELIVERY/POSITIONING, HOWEVER, IT WAS REPORTED AS, NOTHING OUT OF THE ORDINARY." THE LOCATION OF THE RESISTANCE IN THE CATHETER WAS UNKNOWN. THERE WAS NO "VISIBLE" DAMAGE TO THE PHENOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774936 ↗
• MalfunctionNov 17, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM IN THE LEFT C6 SEGMENT. THE OPERATOR SELECTED A SHIELD 500-16 DENSE MESH FLOW-DIVERTING STENT. AFTER THE ACCESS WAS ESTABLISHED, THE STENT WAS DELIVERED TO THE IPSILATERAL M1. ABOUT 7¿8 MM OF THE STENT TIP WAS EXPOSED, BUT AFTER WAITING APPROXIMATELY 10 SECONDS, THE TIP DID NOT OPEN. THE OPERATOR CONTINUED TO DEPLOY THE STENT ABOUT 12 MM, BUT THE TIP STILL FAILED TO OPEN. ATTEMPTS WERE MADE TO RETRIEVE AND REDEPLOY THE STENT, INCLUDING SHAKING AND PUSH-PULL MANEUVERS, BUT THE TIP REMAINED UNOPENED. ADJUSTING THE TENSION OF THE MICROCATHETER ALSO DID NOT RESOLVE THE ISSUE, SO THE STENT WAS REMOVED FROM THE BODY. ON INSPECTION, THE TIP OF THE STENT WAS FOUND TO BE INTERTWINED. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH A SHIELD 500-18 STENT. DURING PREPARATION FOR A SECOND SURGERY, AFTER SUCCESSFUL MICROCATHETER PLACEMENT, DIFFICULTY WAS ENCOUNTERED IN DELIVERING THE GUIDEWIRE. AFTER REMOVAL, A CREASE WAS FOUND IN THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER REPLACING IT WITH ANOTHER CATHETER. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572530 ↗
• MalfunctionNov 4, 2025Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE AND THE CAUSE OF THE BROKEN PUSHWIRE WERE NOT DETERMINED. THERE WAS NO DAMAGE OBSERVED TO THE OTHER CATHETER OR TO THE PED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471757 ↗
• MalfunctionOct 23, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DEFORMATION OF THE GUIDE WIRE COATING WAS OBSERVED, BUT NO OTHER DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS NOTED. IN BOTH DEVICES, THE DISTAL END OF THE PIPELINE DID NOT OPEN, AND NEITHER STENT WAS PLACED IN A VESSEL BEND WHEN THE ISSUE OCCURRED. NO ADDITIONAL STEPS OR DEVICES WERE ATTEMPTED TO OPEN THE PIPELINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368132 ↗
• MalfunctionJun 18, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE 5.00 MM X 16 MM EMBOLIZATION DEVICE WOULD NOT OPEN FULLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR RIGHT INTERIOR CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE ARTERY WAS 3.43 MM DISTALLY AND 4.41 MM PROXIMALLY. IT WAS NOTED THE VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. 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 AS INDICATED. UPON MORE THAN 50% DEPLOYMENT, THE MIDDLE SECTION OF THE DEVICE WOULD NOT OPEN IN THE MIDDLE OF THE BEND IN THE ANTERIOR GENU DESPITE ALL "RESCUE" TECHNIQUES APPLIED. THEY TRIED TO OPEN MORE DISTALLY IN STRAIGHTER SEGMENT AND "PULL BACK" INTO DISTAL LANDING ZONE. THE DEVICE WAS RECAPTURED AND THEY TRIED TO REDEPLOY AND WAG AT THE RIBBONING WITH NO SUCCESS. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE DEVICE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER AND THEY SWITCHED TO A 5X14 DEVICE. RADIOGRAPHIC IMAGING POST PROCEDURE LOOKED SATISFACTORY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284931 ↗
• MalfunctionMay 2, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINE EMBOLIZATION DEVICES FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 1.6 MM AND UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4MM DISTALLY AND 5MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THEY DID NOT TAKE PRU TEST PRIOR TO PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THREE (3) DIFFERENT PIPELINE FLEX WITH SHIELD DEVICES (PED2-500-16, PED2-500-12, PED2-500-20), AND ALL 3 DEVICES FORMED A TRUMPET AT THE DISTAL END OF THE DEVICE AND WOULD NOT OPEN ALL OF THE WAY. THE PROXIMAL END OF ALL 3 DEVICES WOULD OPEN. THEY WERE NOT COMFORTABLE DEPLOYING ANY OF THE DEVICES BECAUSE THE DISTAL END OF THE DEVICE WOULD NOT FULLY OPEN PROPERLY. THEY DECIDED TO PULL ALL DEVICES OUT OF THE PATIENT AND BRING THE PATIENT BACK FOR A DIFFERENT DEVICE. THE PIPELINES WERE NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINES WERE DEPLOYED WHEN THEY FAILED TO OPEN AND THEY WERE RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953419 ↗
• MalfunctionApr 2, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT RELEASE FROM THE PHENOM 27 CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM ON THE LEFT SIDE. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A GOOD RESULT POST PLACEMENT OF NEW PIPELINE. IT WAS REPORTED THAT THE PIPELINE STENT WOULD NOT RELEASE, SO IT WAS REMOVED AND A NEW PIPELINE AS PLACED WITHOUT INCIDENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE CAUSE OF THE PIPELINE NOT RELEASING WAS NOT DETERMINED. FOR CLARIFICATION ON THE INITIAL REPORTED ISSUE, THE PIPELINE FAILED TO OPEN PROXIMALLY/WOULDN¿T RELEASE FROM CATHETER. NO RESISTANCE OCCURRED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN. ANCILLARY DEVICES INCLUDE AN UNKNOWN SHEATH AND PHENOM 27 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756095 ↗
• MalfunctionMar 11, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN MENTIONED THE EVENT OCCURRED AFTER THE DSA FU AT 1YEAR. THEY DID NOT SPECIFIED A DATE: DSA FU WERE PERFORMED BETWEEN (B)(6) 2024 / (B)(6) 2025. THE MORPHOLOGY OF EACH ANEURYSM WAS UNKNOWN AT THE TIME OF THE REPORT. B284636- SHIELD- SIHC- ENDOLEAK WAS NOT SEEN ON THE DAY OF THE IMPLANT PROCEDURE. NOT RESOLVED.

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575395 ↗
• MalfunctionJan 28, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, THE DEVICE'S DISTAL BRAID WOULD NOT OPEN. THE ANEURYSM WAS LOCATED IN THE INTERNAL CAROTID ARTERY, WAS UNRUPTURED, AND HAD A SACCULAR MORPHOLOGY. THE MAX DIAMETER WAS 2MM AND THE NECK DIAMETER WAS 2MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL LANDING ZONE WAS 4.8MM. VESSEL TORTUOSITY WAS MODERATE. THE DEVICE WAS POSITIONED IN A BEND AT THE PROXIMAL AND MIDDLE SECTIONS, AND MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. DESPITE ATTEMPTS TO OPEN THE DISTAL SECTION USING VARIOUS TECHNIQUES, THE DEVICE REMAINED CLOSED. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. THE PIPELINE WAS SUBSEQUENTLY RESHEATHED AND REMOVED FROM THE PATIENT WITHOUT BEING IMPLANTED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). A SECOND STENT WAS SUCCESSFULLY DEPLOYED, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES: RIST 079 SHEATH, APRO 55IC GUIDE CATHETER, PHENOM 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254102 ↗
• MalfunctionJan 15, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THE FIRST PIPELINE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157232 ↗
• MalfunctionJul 11, 2024Stretched; Material Deformation; Activation Failure; Stretched; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT SEVEN PIPELINES FAILED TO OPEN DISTALLY AND BECAME STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE LANDING ZONE WAS 4MM DISTAL AND 5MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS SAID TO BE 80. IT WAS REPORTED THAT THE PHYSICIAN TRIED WITH MULTIPLE PIPELINES IN VARIOUS SIZES, BUT THE SEVERE TORTUOSITY WAS CAUSING THE DEVICES TO STRETCH AND BE UNABLE TO DEPLOY TO THE PHYSICIAN'S STANDARD. THEY WERE FINALLY ABLE TO OPEN A PIPELINE DISTALLY AND DRAG IT INTO PLACE, ALLOWING FOR THE DEVICE TO OPEN AND TREAT THE PATIENT SUCCESSFULLY. THE ENTIRETY OF THE PIPELINES HAD BEEN PLACED IN A BEND WHEN THEY FAILED TO OPEN. THE PIPELINES HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICES. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THE LAST 4 PIPELINES FAILED TO OPEN. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE PATIENT WAS TREAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721803 ↗
• MalfunctionJun 19, 2024Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. MULTIPLE RETRIEVAL ATTEMPTS WERE MADE TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED 3 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568654 ↗
• MalfunctionMay 23, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DUE TO THE TORTUOSITY OF BLOOD VESSEL, IT WAS DIFFICULT TO OPEN THE PED DURING THE DELIVERY PROCESS. AFTER REPEATED PUSHING AND PULLING, THE TIP END WAS DAMAGED. IN ORDER TO ENSURE THE SAFETY OF THE PATIENT, IT WAS TAKEN OUT AND REPLACED. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION. THE MIDDLE PART OF THE PIPELINE WAS POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 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.  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 COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 2 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE WAS 3.5 MM DISTALLY AND 5.0 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S  VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382859 ↗
• MalfunctionApr 11, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DEPLOYMENT SHAPE OF THE TIP END OF THE STENT IN THE BODY WAS ABNORMAL, UNABLE TO BE OPENED, AND WAS IN THE SHAPE OF A BELL MOUTH. AFTER BEING WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE TIP END OF THE STENT WAS DAMAGED AND BURRS APPEARED. AFTER THE STENT WAS REPLACED, THE IMPLANTATION WAS SMOOTH. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. DAPT WAS ADMINISTERED. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE BLOOD FLOW WAS SMOOTH AND THE STENT ADHERED TO THE WALL WELL. THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). 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 WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. LANDING ZONE WAS 4.5MM DISTAL AND 5.2MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086930 ↗
• MalfunctionMar 13, 2024Collapse; Activation Failure; Physical Resistance/Sticking; Collapse; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WASN'T ANY RESISTANCE NOTED DURING DELIVERY OR BRINGING THE DEVICE UP TO POSITION. NO DAMAGE WAS SEEN ON THE PUSHER WIRE OR PHENOM 27 CATHETER. THE PROXIMAL END OF THE 1ST DEVICE WAS SLIGHTLY OPEN IN THE ICA BUT ONCE DEVICE WAS REMOVED IT WAS OPEN BUT LOOKED LIKE BRAID COLLAPSE. THE 2ND DEVICE THAT WAS USED AND DEPLOYED WAS A PIPELINE. THERE WAS NOT AN ISSUE WITH THE PHENOM 27 CATHETER THAT WAS SEEN BUT THE DOCTOR ASKED FOR A NEW PHENOM 27 JUST TO BE SAFE. THE SECOND STENT WAS DEPLOYED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896917 ↗
• MalfunctionDec 20, 2023Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369889 ↗
• InjuryDec 14, 2023Material Frayed; Activation Failure; Material Frayed; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINE DEVICES FAILED TO OPEN IN THE DISTAL SECTION. THE PROCEDURE WAS ULTIMATELY ABORTED DUE TO DIFFICULTY PLACING THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 4.5 MM DISTALLY AND 4.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESSED VESSEL WAS THE ICA. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NOT COMPLETED BECAUSE THE PROCEDURE WAS ABORTED DUE TO DIFFICULTIES PLACING THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO GET THE 500 X 18 PIPELINE SHIELD (PED2-500-18) TO OPEN ON THE DISTAL END. HE TRIED MULTIPLE TIMES TO OPEN THE DEVICE BUT THE DISTAL END WOULD NOT OPEN. THE MEDIAL SEGMENT DID OPEN. PHYSICIAN BECAME CONCERNED THAT THERE WAS SOMETHING WRONG WITH THE 5X18 PIPELINE SHIELD DEVICE AND ELECTED TO REMOVE THE SYSTEM AND TRY A DIFFERENT DEVICE. HE THEN LOADED A 5.00 X 16 PIPELINE SHIELD (PED2-500-16) INTO A NEW PHENOM 27 MICRO-CATHETER AND TRIED TO DELIVER THE PIPELINE BUT EXPERIE

  Patient problems: Failure of Implant

  MAUDE report 18326155 ↗
• MalfunctionNov 22, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT COMPLETELY OPEN AFTER RESHEATHING IT TWICE. THE MIDDLE OF THE PIPELINE WAS POSITIONED IN A BEND AND LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED PER 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 AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 10MM AND A 7MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 4.75MM PROXIMALLY AND DISTALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191030 ↗
• DeathNov 17, 2023Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEATH WAS NOT THOUGHT TO BE RELATED TO THE MEDTRONIC DEVICE/THERAPY.

  Patient problems: Ruptured Aneurysm

  MAUDE report 18164783 ↗
• MalfunctionNov 15, 2023No Apparent Adverse Event; Activation Failure; No Apparent Adverse Event; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT DID NOT OPEN AT THE DISTAL END. THE DEVICE FAILED. IT WAS REMOVED AND ANOTHER STENT WITH THE SAME DIMENSIONS WAS REQUIRED TO BE USED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING CEREBRAL ANGIOGRAM FOR LEFT INTERNAL CAROTID ARTERY ANEURYSM STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144607 ↗

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-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