PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000284459), received between Dec 22, 2021 and Jan 12, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Positioning Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE POSITION OF THE PIPELINE WAS UNSATISFACTORY AND THE STENT BECAME DETACHED. THE PATIENT WAS UNDERGOING ANEURYSM FLOW-DIVERTING STENT IMPLANTATION SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY, C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.6 MM DISTALLY AND 4.1 MM PROXIMALLY. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SLOWED BLOOD FLOW WITHIN THE ANEURYSM. IT WAS REPORTED THAT AN ANEURYSM AT THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY WAS TREATED WITH A FLOW-DIVERTING STENT IMPLANTATION. DURING THE PROCEDURE, THE PHENOM 27 MICROCATHETER WAS ADVANCED INTO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. A PED2-425-20 STENT WAS SELECTED AND DELIVERED TO THE LESION SITE. AFTER RETRACTING THE MICROCATHETER, THE STENT WAS DEPLOYED, AND THE TIP END OF THE STENT OPENED SMOOTHLY. WHEN THE STENT WAS PULLED BACK AND POSITIONED AT THE DISTAL NECK OF THE ANEURYSM, THE POSITION WAS UNSATISFACTORY. THE OPERATOR ATTEMPTED TO RETRIEVE AND REDEPLOY THE STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035597 ↗
• MalfunctionDec 19, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL STEPS ATTEMPTED TO OPEN THE DEVICE INCLUDED ATTEMPTS WERE MADE TO RETRIEVE AND MANIPULATE (PUSH AND PULL) THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849131 ↗
• MalfunctionDec 18, 2025Positioning Failure; Material Deformation; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSES OF THE RESISTANCE, STENT FAILURE TO OPEN, STENT DAMAGE/DEFECT, AND CATHETER DAMAGE/DEFECT WERE NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. DIFFICULTY WAS ENCOUNTERED DURING DELIVERY, AND THE PIPELINE WAS UNABLE TO OPEN AND WAS THEREFORE NOT IMPLANTED AT THE INTENDED LOCATION. THERE WAS NO DEVICE JUMPING OR CATHETER TIP MOVEMENT DURING DEPLOYMENT. THE SECTION OF THE PIPELINE THAT DID NOT OPEN WAS THE TIP. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR OTHER DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE, SUCH AS RESHEATHING OR USING A WIRE, CATHETER, OR BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839264 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED SITE NOTED PREVIOUS ENTRY FOR MRS2 AT 1-YEAR FOLLOW-UP WAS INCORRECT. THE PATIENT'S MRS AT 1-YEAR FOLLOW-UP HAS BEEN CORRECTED TO 0. REGARDING OBSERVED R OCCLUSION CLASS 2: THE PATIENT HAD NO ASSOCIATED SYMPTOMS. NO ACTIONS TAKEN OR PLANNED FOR OBSERVED INCOMPLETE OCCLUSION. THE EVENT DID NOT RESULT IN HOSPITALIZATION. BASED ON ADDITIONAL INFORMATION RECEIVED, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE THERE WAS NO SERIOUS PATIENT INJURY. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTING IS REQUIRED FOR THIS EVENT UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: Aneurysm; Nervous System Injury

  MAUDE report 23496975 ↗
• MalfunctionNov 3, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PREVIOUSLY RECEIVED INFORMATION INDICATING "TUBE DAMAGE" WAS REFERRING TO POSSIBLE CATHETER DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455231 ↗
• MalfunctionOct 31, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO DAMAGE TO THE BLOOD VESSELS CAUSED BY THE MEDTRONIC DEVICE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441647 ↗
• MalfunctionOct 15, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING; DEPLOYMENT WAS SMOOTH WITH NO ISSUES. HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE MICROCATHETER IN THE M1 SEGMENT WHEN RETRIEVING THE DELIVERY WIRE. THE CATHETER WAS FLUSHED ACCORDING TO THE IFU DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293364 ↗
• MalfunctionApr 18, 2025Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE PIPELINE FAILURE WAS NOT DETERMINED. ONE PIPELINE WAS BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY OR POSITIONING, AND THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER HAD BEEN MOVED DURING DEPLOYMENT. THE PIPELINE WAS PLACED IN A STRAIGHT PART OF THE VESSEL AND NOT A BEND WHEN IT FAILED TO OPEN. THEY HAD RETRIEVED AND DEPLOYED THE PIPELINE MULTIPLE TIMES TO TRY TO OPEN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865518 ↗
• MalfunctionApr 3, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE INTRACRANIAL ANEURYSM EMBOLIZATION WAS PERFORMED. AFTER THE CATHETER WAS IN PLACE, THE BLOOD VESSEL DIAMETER WAS MEASURED AND PED2-425-20 WAS SELECTED FOR DEPLOYMENT. THE STENT TIP COULD NOT BE OPENED. AFTER MULTIPLE ATTEMPTS, IT STILL COULD NOT BE OPENED. THE CATHETER WAS WITHDRAWN AND THE OPERATION WAS CANCELLED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 4.3 MM DISTAL AND 4.4 MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761621 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SOURCE STATED THE PATIENT WAS NOTED TO HAVE ACID REFLUX BY AN ENT PROVIDER WHICH WAS A NEW DIAGNOSIS. THEY WERE CONCERNED THAT THE CLOPIDOGREL COULD BE CAUSING THE ACID REFLUX.

  Patient problems: Dysphasia; Headache; Vasoconstriction

  MAUDE report 21686605 ↗
• MalfunctionFeb 18, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT MULTIPLE ANEURYSMS OCCURRED IN THE OPHTHALMIC ARTERY SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE FEMORAL ARTERY WAS PUNCTURED. THE 6F LONG SHEATH SUCCESSFULLY REACHED THE C1 SEGMENT OF THE INTERNAL CAROTID ARTERY UNDER THE GUIDANCE OF A 0.035-INCH LOACH GUIDEWIRE AND A MULTIFUNCTIONAL ANGIOGRAPHY TUBE. AT THE SAME TIME, TETHYS 6F SUCCESSFULLY REACHED THE CAVERNOUS SINUS SEGMENT WITH THE ASSISTANCE OF A GUIDEWIRE. 3D ROTATIONAL ANGIOGRAPHY WAS PERFORMED TO MEASURE THE SIZE OF BLOOD VESSELS AND ANEURYSMS, AND THE PED2-425-20 MODEL WAS FINALLY SELECTED. PHENOM27 SUCCESSFULLY REACHED THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY UNDER THE GUIDANCE OF THE SYCHRO 0.014-INCH GUIDEWIRE. THE STENT WAS FULLY HYDRATED AND FLUSHED, AND THE STENT WAS DELIVERED TO THE M1 HORIZONTAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PUSH ROD WAS HELD AND THE STENT CATHETER WAS PULLED BACK TO EXPOSE THE STENT TIP. HOWEVER, IT HAD BEEN DEPLOYED FOR 10 MM AND THE TIP STILL DID NOT OPEN COMPLETELY. SO, THE WHOLE THING WAS PULLED BACK TO THE INTERNAL CAROTID ARTERY, BUT IT STILL DID NOT OPEN COMPLETELY. THE WHOLE THING WAS PUSHED AND PULLED AND SWUNG SLIGHTLY BUT STILL DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395391 ↗
• MalfunctionOct 9, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN. PIPELINE WOULD NOT OPEN AT THE TURN ON THE DISTAL EDGE OF THE ANEURYSM NECK. IT FAILED TO OPEN IN THE MIDDLE SECTION. THE MIDDLE OF THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO OTHER ACTIONS WERE TAKEN TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICRO CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 3.78MM AND THE NECK DIAMETER WAS 5MM. THE DISTAL LANDING ZONE WAS 3.5MM AND THE PROXIMAL LANDING ZONE WAS 3.78MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: 90CM BALLAST SHEATH, 058 NAVIEN GUIDE CATHETER, PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413836 ↗
• MalfunctionAug 7, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE BREAK. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) C5 SEGMENT UNRUPTURED SACCULAR ANEURYSM VIA RIGHT FEMORAL ACCESS. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH PRU LEVEL 200 NOTED. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY BUT IT WAS THOUGHT THAT THE PIPELINE STENT UNLOADED PREMATURELY WITHIN THE CATHETER SO THE SYSTEM WAS REMOVED TOGETHER. IT WAS THEN OBSERVED THAT THE PIPELINE PUSHWIRE HAD BROKEN AT THE HYPOTUBE, PROXIMAL TO THE WIRE WELD. NO SEGMENT WAS LEFT IN THE PATIENT. BECAUSE THERE WAS NO IDENTICAL PIPELINE IN STOCK AT THE HOSPITAL, A DIFFERENT MODEL OF PIPELINE (4.25 X 18) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY SHOWED CONTRAST WAS RETAINED INT HE ANEURYSM AND THE ANEURYSM WAS WELL COVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929445 ↗
• MalfunctionDec 22, 2021Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE TIP WAS DAMAGED. IT WAS REPORTED THAT THE PHYSICIAN WANTED TO SHAPE THE TIP COIL. SO ON THE BACK TABLE THEY ATTEMPTED TO SHAPE THE TIP. DURING THE SHAPING THE TIP WAS DAMAGED. DEVICE WAS REMOVED FROM STERILE FIELD AND A NEW DEVICE WAS SELECTED AND IMPLANTED WITHOUT INCIDENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ANY ACCESSORY DEVICES WERE NOT PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064147 ↗

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-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-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-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