PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000284718), received between Oct 15, 2021 and Feb 5, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (32 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Use of Device Problem; Patient-Device Incompatibility; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF TWO PIPELINE DEVICES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C7 SEGMENT WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. THE LANDING ZONE OR ARTERY SIZE WAS 4.7MM DISTAL AND 5.1MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS ANEURYSM SHOWED SIGNIFICANT CONTRAST AGENT RETENTION, WITH NO VASCULAR LOSS. IT WAS REPORTED THAT THERE WAS A SLIGHT ISSUE WITH THE SIZE OF THIS BATCH OF STENTS. SPECIFICALLY, THE OPERATOR PERFORMED BOTH 2D AND 3D MEASUREMENTS AND SELECTED A PED2-500-18 STENT. AFTER THE ASSISTANT PLACED IT IN POSITION, STENT DELIVERY BEGAN. THE PHENOM 27 REACHED THE M2 SEGMENT, STENT DELIVERY WAS STARTED, ONCE THE MAIN PART OF THE STENT REACHED THE STRAIGHT SEGMENT OF THE M1 MIDDLE CEREBRAL ARTERY, STENT DEPLOYMENT WAS INITIATED. THE MICROCATHETER WAS WITHDRAWN TO DEPLOY THE TIP OF THE STENT, WITH APPROXIMATELY 8 MM RETRACTION OF THE MICROCATHETER, BUT THE STENT DID NOT OPEN. THE OPERATOR REPORTED WAITING FOR ABOUT ONE MINUTE, BUT THE TIP OF THE STENT STI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269062 ↗
• MalfunctionJan 12, 2026Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PIPELINE DID NOT OPEN AT THE DISTAL SECTION. THE PIPELINE WAS NOT PLACED IN A BEND WHEN IT FAILED TO OPEN AND WAS RESHEATHED 0 TIMES. THERE WAS NOT ANY RESISTANCE DURING DELIVERY OR RETRIEVAL OF THE PIPELINE. THERE WAS NO REPORTED DAMAGE OR ISSUE WITH THE PHENOM 27 MICROCATHETER. CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE AS INDICATED BY THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037850 ↗
• 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 23803433 ↗
• MalfunctionNov 18, 2025Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO OPEN/PIPELINE DAMAGE WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED DURING DELIVERY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. 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. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE. FOR THE SECOND PIPELINE STENT, THE PUSHING AND PULLING WAS DONE BECAUSE THE DEVICE FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584169 ↗
• MalfunctionOct 22, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO RESISTANCE DURING DELIVERY OF THE PIPELINE. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360448 ↗
• MalfunctionSep 9, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DID NOT OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 5.37 MM AND A 4.42 MM NECK DIAMETER. THE LANDING ZONE WAS 4.47 MM DISTALLY AND 4.93 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHILE USING A PHENOM 27 MICROCATHETER GUIDED BY A 0.014 NEURO GUIDEWIRE, IT WAS PUSHED TO THE UPPER M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. A PIPELINE STENT WAS DELIVERED THROUGH THE PHENOM 27 TO THE STRAIGHT SEGMENT OF THE M1. UPON RETRIEVING THE MICROCATHETER IN SITU TO DEPLOY THE STENT TIP, IT WAS OBSERVED THAT THE STENT TIP DID NOT OPEN. ADDITIONAL LENGTH WAS DEPLOYED, BUT THE STENT STILL DID NOT FULLY OPEN. APPLYING TENSION DID NOT RESOLVE THE ISSUE. A DISTAL ACCESS CATHETER WAS PUSHED, AND THE STENT WAS RETRIEVED AND REDEPLOYED, BUT THE TIP STILL DID NOT FULLY OPEN. ATTEMPTS WERE MADE TO RETRIEVE THE ENTIRE STENT TO THE INTERNAL CAROTID ARTERY AND ADJUST THE TENSION LEVEL, BUT THE STENT TIP STILL DID NOT OPEN PROPERLY. THE STENT WAS SUBSEQUENTLY RETRIEVED ENTIRELY AND REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003248 ↗
• MalfunctionJul 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS BEING TREATED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO RESISTANCE IN THE CATHETER, AND THE STENT TIP COULD NOT OPEN AFTER THE STENT WAS PUSHED OUT OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR PIPELINE PUSHWIRE AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677838 ↗
• MalfunctionJul 29, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 5MM DISTALLY AND 4.5MM PROXIMALLY. THE ACCESS VESSEL WAS A FEMORAL ARTERY, WITH 6MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN.  IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON ENCOUNTERED AN ISSUE; THAT THE TIP OF THE FIRST PIPELINE PED STENT COULDN'T BE OPENED. IT WAS REPLACED WITH A SECOND STENT, WHICH STILL FAILED TO OPEN. . DURING THE PROCEDURE, ATTEMPTS SUCH AS PUSHING, PULLING, AND RETRIEVAL WERE MADE, BUT THE STENTS STILL COULD NOT BE OPENED. AFTER REPLACED IT WITH A THIRD STENT, THE PROCEDURE WAS COMPLETED. THE EXACT CAUSE OF THE STENT OPEN FAILURE REMAINED UNCLEAR. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS INTRACRANIAL ANEURYSM. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647076 ↗
• MalfunctionJul 28, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER MEASUREMENT, A 5-18 STENT WAS SELECTED. ONCE THE MICROCATHETER WAS IN PLACE, THE STENT WAS DELIVERED, AND THE TIP OF THE STENT WAS DEPLOYED. HOWEVER, THE TIP OF THE STENT FAILED TO OPEN. REPEATED ATTEMPTS TO RETRIEVE AND REDEPLOY IT WERE UNSUCCESSFUL, SO THE MICROCATHETER AND STENT WERE REMOVED. EXAMINATION OUTSIDE THE BODY REVEALED THAT THE TIP OF THE STENT WAS FRIZZY AND SLIGHTLY DAMAGED. A NEW MICROCATHETER AND STENT WERE SELECTED TO COMPLETE THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. 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 OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE DISTAL LANDING ZONE WAS 4.9 MM, THE PROXIMAL LANDING ZONE WAS 5.9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS BLOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631227 ↗
• MalfunctionJul 23, 2025Positioning Failure; Retraction Problem; Malposition of Device; Material Deformation; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Retraction Problem; Malposition of Device; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS GREAT RESISTANCE DURING DELIVERY OR POSITIONING IN THE DISTAL SECTION OF THE CATHETER. CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE OBSERVED TO THE CATHETER AFTER REMOVAL. THE PIPELINE PUSHWIRE WAS KINKED. MULTIPLE PIPELINES WERE NOT BEING USED WHEN THE MOVEMENT OCCURED. THE PIPELINE WAS NO IMPLANTED AT THE INTENDED LOCATION. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. IT WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. PUSHED MIDDLE CATHETER TO GO UPPER IN AN ATTEMPT TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580689 ↗
• MalfunctionJul 9, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT CAVERNOUS CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.8MM AND A 4.1MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.85MM AND PROXIMAL: 4.76MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. PATIENT WAS NOTED TO HAVE A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, CONVENTIONAL DUAL ANTIBODY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE SURGEON USED A DENSE MESH STENT TO TREAT THE ANEURYSM. AFTER THE STENT CATHETER WAS DELIVERED TO THE DISTAL END OF THE MIDDLE CEREBRAL ARTERY M1, THE STENT WAS DELIVERED AND IN PLACE, AND THE STENT WAS DEPLOYED FROM THE STRAIGHT SECTION OF M1. DURING THE STENT DEPLOYMENT PROCESS, THE TIP END FAILED TO OPEN SMOOTHLY. THE SURGEON THEN DEPLOYED THE STENT ABOUT 15 MM. THE MIDDLE SECTION OF THE STENT OPENED, BUT THE TIP END STILL FAILED TO OPEN. THE SURGEON TRIED TO WAIT AND STILL FAILED TO OPEN. THEN PARTIALLY RETRIEVED THE STENT AND PULLING THE STENT INTO THE INTERNAL CAROTID ARTERY, THE TIP END OF THE STENT S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458156 ↗
• MalfunctionApr 2, 2025Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE PROXIMAL AND DISTAL ENDS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED RIGHT CAROTID TERMINUS WITH A MAX DIAMETER OF 7MM. LANDING ZONE: DISTAL: 2.5MM AND PROXIMAL: 3.75MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED ADEQUATE PIPELINE DEPLOYMENT. IT WAS REPORTED THAT THE PROXIMAL END OF THE STENT FAILED TO OPEN ONCE DEPLOYED. THEN THERE WAS AN INABILITY TO ADVANCE THE PHENOM 27 THROUGH THE PIPELINE. THE PHENOM COULD NOT TRACK OVER THE PUSHWIRE TO RECAPTURE PTFE SLEEVES. THE PHYSICIAN WAS ALSO UNABLE TO REMOVE THE PUSHER WIRE FROM THE DEVICE AS IT GOT CAUGHT ON DISTAL END OF THE STENT. THE PHYSICIAN WAS ABLE TO GET A 014 WIRE INTO THE DEVICE BUT WERE UNABLE TO GET THE DISTAL END TO OPEN WITH THE 014 WIRE. AS THE PHYSICIAN WAS UNABLE TO ADVANCE THE PHENOM AND REMOVE THE PUSHER WIRE, THEY WERE UNABLE TO USE A BALLOON OR ANY OTHER DEVICE TO OPEN THE STENT. AN ATLAS STENT WAS PLACED ON THE DISTAL END OF THE PIPELINE TO KEEP IN PLACE AND THIS HAD TO BE PLACED RETROGRADE. THE PIPELINE'S PROXIMAL AND DISTAL ENDS HAD BEEN POSITIONED IN A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752683 ↗
• MalfunctionMar 31, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE PIPELINE HAD BEEN POSITIONED IN A STRAIGHT SEGMENT AND NOT A BEND WHEN IT FAILED TO OPEN. THEY RETRIEVED THE PIPELINE AND TRIED TO DEPLOY IT AGAIN IN ORDER TO OPEN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730036 ↗
• 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. B285302- SHIELD- JMF ¿ ENDOLEAK NOT RESOLVED. RT PETROUS CAVERNOUS ANEURYSM STILL FILLING WITH FLOW RESTRICTION THAT WAS NOT SEEN ON THE DAY OF THE IMPLANT.

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

  MAUDE report 21575495 ↗
• MalfunctionFeb 5, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PREMATURE DEPLOYMENT OCCURED WHEN ATTEMPTING TO RESHEATH THE DEVICE. THE PUSHWIRE ROTATED OR PULLED BACK IN ORDER TO RESHEATH. THREE DEVCIES WERE RETURNED. ONE REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318444 ↗
• MalfunctionJan 24, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE FLEX DEVICE, THE DISTAL END OF THE DEVICE APPEARED CRIMPED AND WOULD NOT OPEN. THE ANEURYSM WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY AT THE OPHTHALMIC ARTERY, WAS UNRUPTURED, AND HAD A SACCULAR MORPHOLOGY. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 5 MILLIMETERS AND A NECK DIAMETER OF 4 MILLIMETERS. THE DISTAL LANDING ZONE WAS 4.1 MILLIMETERS, AND THE PROXIMAL LANDING ZONE WAS 5 MILLIMETERS, WITH NORMAL VESSEL TORTUOSITY. THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE BY UNSHEATHING IT IN THE M1 SEGMENT, BUT THE DISTAL END REMAINED CRIMPED AND FAILED TO OPEN, ALTHOUGH THE MID PORTION DID OPEN. THE DEVICE WAS RESHEATHED AND REPOSITIONED AT THE TARGET LOCATION, BUT THE DISTAL END STILL DID NOT OPEN. THIS WAS THE THIRD DEVICE IN A CONSTRUCT, AND THE DECISION WAS MADE TO REMOVE THE DEVICE ENTIRELY. THIS WAS THE SECOND PIPELINE FLEX 5 X 18 DEVICE THAT WAS USED. THE FIRST DID THE EXACT SAME THING. IT WAS ALSO REMOVED AND DISCARDED. THE PIPELINE WAS NOT PLACED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228892 ↗
• MalfunctionJan 24, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED AFTER THE SECOND 5X18 PIPELINE DID NOT OPEN, THE PHYSICIAN REMOVED THE DEVICE AND ENDED THE CASE. THE PATIENT WAS LEFT WITH ONE 4.25X25 AND ONE 4.5X25 PIPELINE DEVICE. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228866 ↗
• MalfunctionOct 1, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN AND THE FIRST BECAME STUCK IN THE PHENOM 27 MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 4MM. THE LANDING ZONE WAS 5MM, DISTAL AND 4MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT THE TIP OF THE PIPELINE COULD NOT BE OPENED AFTER IT WAS PUSHED OUT OF THE CATHETER. IT STILL DID NOT OPEN AFTER REPEATED RETRIEVAL. THE STENT WAS THEN RETRIEVED AND REMOVED FROM THE BODY, BUT IT GOT STUCK AT THE PROXIMAL END OF THE CATHETER AND COULD NOT BE REMOVED. A NEW CATHETER AND PIPELINE WERE USED. THE STENT WAS PUSHED OUT OF THE CATHETER AFTER IT WAS IN PLACE, BUT THE STENT TIP STILL COULD NOT BE OPENED. REPEATED RETRIEVAL AND ADJUSTMENT OF THE DEPLOYMENT POSITION WERE INEFFECTIVE, SO THE STENT WAS REMOVED AND THE SURGERY WAS RESCHEDULED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED BLOOD RETENTION IN THE ANEURYSM. THE DEVICES WERE PREPARED AND FLUSHED ACCORD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349070 ↗
• 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 19721808 ↗
• MalfunctionJul 11, 2024Material Deformation; Activation Failure; Material Deformation; 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 IN THE LEFT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2.8 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.7 MM AND PROXIMAL: 5.1 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NO EFFECT. IT WAS REPORTED THAT AFTER THE STENT WAS DELIVERED, THE TIP END COULD NOT BE OPENED AFTER TENSION DEPLOYED, AND IT WAS IN A TRUMPET SHAPE. IT STILL COULD NOT BE OPENED AFTER RETRACTION AND GROWTH. THE STENT WAS REPLACED TO COMPLETE THE SURGERY. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 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 THE MICROCATHETER. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE REPORTED DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720655 ↗
• MalfunctionJun 3, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE ACCESS WAS ESTABLISHED, AFTER INTRAOPERATIVE MEASUREMENT AND CALIBRATION, THE PED2-5-18 STENT WAS SELECTED, THE STENT MICROCATHETER WAS PUSHED TO GO UPPER TO BEYOND M2, AND THEN THE STENT WAS DELIVERED. WHEN THE STENT TIP REACHED M2, THE STENT TIP WAS SLOWLY OPENED. HOWEVER, ONCE IT CAME OUT OF THE MICROCATHETER, THE STENT TIP WAS DAMAGED, SO THE STENT WAS REPLACED. PED2-5-20 WAS SELECTED, BUT THE STENT TIP STILL SHOWED THE SAME PROBLEM AS THE FIRST STENT. AS SOON AS IT CAME OUT OF THE MICROCATHETER, THE TIP WAS FOUND TO BE DAMAGED. AFTER RETRIEVING AND OTHER OPERATIONS, THE STENT TIP COULD NOT BE OPENED. FINALLY, PED2-475-20 WAS REPLACED, AND THE STENT TIP WAS SUCCESSFULLY OPENED AT ONE TIME, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED AND THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT SIDE, OPHTHALMIC ARTERY SEGMENT, CAVERNOUS SINUS SEGMENT WITH MULTIPLE ANEURYSMS. MAX DIAMETER WAS 3MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447818 ↗
• MalfunctionJun 3, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THEY TRIED OPENING DEVICE IN M1 AND WOULD NOT OPEN DISTALLY AFTER SEVERAL ATTEMPTS. BODY DID OPEN NICELY BUT DISTAL END CRIMPED. THE PIPELINE WAS NOT POSITIONED IN A BEND AND IT WAS NOT STUCK IN THE CAPTURE COIL. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT WAS RESHEATHED "LESS THAN OR EQUAL TO 2 TIMES." NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. IT GOT STUCK IN HUB OF PHENOM 27 UPON RESHEATHING AND REMOVING. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED AND 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 RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 8MM AND A 5MM NECK DIAMETER. LANDING ZONE WAS 4.2MM DISTAL AND 5.1MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, PRU LEVEL WAS 110. ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL.   ANCILLARY DEVICES INCLUDE A BMX GUIDE CATHETER AND A PHENOM 27 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447445 ↗
• 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 18326151 ↗
• MalfunctionOct 31, 2023Device Damaged by Another Device; Activation Failure; Device Damaged by Another Device; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CATHETER FG15150-0615-1S REACHED THE DISTAL END OF THE DISEASED BLOOD VESSEL, PUSHED PED2-500-25 AND BEGAN TO DEPLOY. AFTER MANY ATTEMPTS, THE TIP END COULD NOT BE FULLY OPENED AND ATTACHED TO THE WALL, SO IT WAS WITHDRAWN FROM THE BODY AND FOUND THAT THE TIP END OF THE STENT WAS DAMAGED AND HAD BURRS. SO REPLACED THE STENT PED2-500-18 AND DEPLOYED AGAIN. THE TIP END STILL COULD NOT BE FULLY OPENED AND ATTACHED TO THE WALL. AFTER THE WHOLE WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE TIP END OF THE STENT WAS STILL DAMAGED. THERE WERE BURRS, IT WAS SUSPECTED TO BE A PROBLEM WITH THE CATHETER FG15150-061501S. FINALLY, THE CATHETER FG15150-0615-1S AND THE STENT PED-500-20 WERE REPLACED AS A WHOLE AGAIN. THEY WERE DEPLOYED SMOOTHLY, THE STENT ADHERED WELL TO THE WALL, AND THE OPERATION ENDED SUCCESSFULLY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED C4 ANEURYSM W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038400 ↗
• MalfunctionSep 20, 2023Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED THAT THERE ARE NO IMAGES AVAILABLE. THERE WAS NO ISSUE WITH THE PHENOM CATHETER DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785295 ↗

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-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-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-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-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