PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000284350), received between Apr 14, 2022 and Apr 24, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Unintended Ejection; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT CLINOID C5 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.3 MM AND A 3.0 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7.8MM DIAMETER. THE LANDING ZONE WAS 3.1MM DISTALLY AND 4.0MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT AFTER THE OPERATOR ESTABLISHED ACCESS, A PHENOM 27 MICROCATHETER WAS POSITIONED IN PLACE. A SHIELD PED400-18 DEVICE WAS UNPACKED AND HYDRATED. THE DISTAL END OF THE DEVICE WAS ADVANCED THROUGH THE Y-VALVE TO THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. WHILE THE ASSISTANT ADVANCED THE DELIVERY WIRE TO ITS FULL EXTENT, VERY LITTLE RESISTANCE WAS NOTED. THE DISTAL END OF THE DEVICE WAS UNABLE TO ENTER THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. THE OPERATOR THEN WITHDREW THE ENTIRE DEVICE ONTO THE TABLE AND ATTEMPTED TO ADVANCE THE DELIVERY WIRE BACK AND FORTH; HOWEVER, THE STENT REMAINED STATIONARY. IT WAS SUBSEQUENTLY NOTED THAT THE DEVICE HAD BECOME DETACHED (DEVICE DETACHMENT). THE OPERATOR THEN REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982534 ↗
• MalfunctionJan 12, 2026Retraction Problem; Unintended Movement; Migration; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN INTRACRANIAL ANEURYSM PROCEDURE TREATED WITH PIPELINE IMPLANTATION USING THE MARKSMAN CATHETER 150CM, CATHETER RESISTANCE WAS ENCOUNTERED AT THE DISTAL END. AFTER SUCCESSFUL STENT DEPLOYMENT, THE STENT PUSH ROD DISTAL END COULD NOT BE WITHDRAWN INTO THE CATHETER, RESULTING IN THE TIP RADIOPAQUE MARKER WIRE AND PROTECTIVE SLEEVE REMAINING OUTSIDE THE CATHETER. THE OPERATOR WAS REQUIRED TO REMOVE BOTH THE CATHETER AND PUSH ROD TOGETHER, AND BECAUSE THE PUSH ROD COULD NOT BE FULLY WITHDRAWN, ITS DISTAL PART REMAINED OUTSIDE THE CATHETER AND INTERFERED WITH THE STENT TIP DURING SYSTEM REMOVAL. THIS INTERFERENCE CAUSED THE STENT TIP TO SHIFT DOWNWARD BY APPROXIMATELY 3 MILLIMETERS. THE OPERATOR HAD ANCHORED THE STENT SUFFICIENTLY HIGH, SO AFTER THE SHIFT, THE STENT DISTAL END MAINTAINED A 4 MILLIMETER ANCHORING DISTANCE FROM THE ANEURYSM OUTFLOW TRACT. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7.6 MILLIMETERS, AND VESSEL TORTUOSITY WAS NORMAL. THE CATHETER AND ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. NO PATIENT COMPLICATIONS OR INJURIES HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037538 ↗
• MalfunctionOct 27, 2025Retraction Problem; Device Dislodged or Dislocated; Unintended Movement; Physical Resistance/Sticking; Retraction Problem; Device Dislodged or Dislocated; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE DISTAL SECTION OF THE PHENOM 27 CATHETER. THE PATIENT WAS UNDERGOING NEURO-INTERVENTIONAL MINIMALLY INVASIVE SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 6.4 MM AND A 4.3 MM NECK DIAMETER. THE LANDING ZONE WAS 2.9 MM DISTALLY AND 3.9 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 5.7 MM DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT A FEMORAL ARTERY PUNCTURE WAS PERFORMED, AND A 6F LONG SHEATH WAS SUCCESSFULLY PLACED IN THE COMMON CAROTID SINUS OVER A 0.035-INCH LOACH GUIDEWIRE AND A 125 MULTI-KINETIC ANGIOGRAPHY CATHETER. A 6F 115CM INTERMEDIATE CATHETER WAS THEN PLACED IN THE CAVERNOUS SINUS, AND A PHENOM 27 WAS SUCCESSFULLY PLACED IN THE M1 AND M2 POSITIONS OVER A NON-MEDTRONIC GUIDEWIRE. BASED ON 3D ANGIOGRAPHY, A PIPELINE WAS SELECTED. AFTER FULL HYDRATION WITH HIGH-PRESSURE SALINE, THE STENT WAS SUCCESSFULLY DELIVERED. THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23396268 ↗
• MalfunctionMar 6, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE PUSHWIRE BREAK WAS UNKNOWN. THERE WAS NO ISSUE WITH THE PHENOM CATHETER; FROM THE NAKED EYE OBSERVATION OF THE MORPHOLOGY AND USE, THE CUSTOMER DID NOT REPORT ANY PROBLEMS. THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE REACTIONS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536139 ↗
• MalfunctionJan 3, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PART OF THE DISTAL END CLOSE TO THE PROXIMAL END FAILED TO OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066286 ↗
• MalfunctionMay 24, 2024Malposition of Device; Malposition of Device

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN INTERNAL CAROTID ARTERY ANEURYSM, WHICH WAS ACCESSED THROUGH THE RIGHT RADIAL ARTERY. 6F105 DISTAL ACCESS CATHETER TO ESTABLISH ACCESS, ANEURYSM NECK WIDTH 4MM.  HEALTHCARE PROVIDER (HCP) USED A 3.5-16 BLOOD FLOW DIVERSION DENSE MESH STENT. AFTER THE PROXIMAL END OF THE STENT WAS ANCHORED AND OPENED, WHEN THE TAIL END OF THE STENT HAD NOT REACHED THE DETACHMENT POINT, THE STENT WAS DETACHED PREMATURELY. DSA ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS NOT COMPLETELY COVERED, BECAUSE THE SAME TYPE OF STENT WAS NOT AVAILABLE, AND THEN IT WAS BRIDGED AND IMPLANTED WITH A BLOOD FLOW DIVERSION DENSE MESH STENT 4-18. AFTER THE STENT WAS DEPLOYED, DSA ANGIOGRAPHY SHOWED RETENTION OF CONTRAST AGENT IN THE ANEURYSM AND THE ANEURYSM WAS WELL SEALED. 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 LEFT OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY AN EURYSM WITH A MAX DIAMETER OF 4.7 MM AND A 3.3 MM NECK DIAMETER

  Patient problems: Failure of Implant

  MAUDE report 19392194 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT DEVELOPED AN INTRACRANIAL HEMORRHAGE FOUR DAYS POST PIPELINE PLACEMENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A BILOBE, UNRUPTURED ANEURYSM IN THE M1/M2 BIFURCATION WITH A MAX DIAMETER OF 21 MM. THE LANDING ZONE WAS 1.4 MM DISTALLY AND 3.75 MM PROXIMALLY. TWO DEVICES WERE USED (DISTAL AND PROXIMAL). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PATIENT WAS ON BRILINTA. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS CLEAR. IT WAS REPORTED THAT THE PROCEDURE WENT WELL, PATIENT IN DISCHARGED WITHIN 24 HOURS, RETURNED 4 DAYS AFTER PROCEDURE WITH CONTRALATERAL INTRACRANIAL HEMORRHAGE. AT THE TIME OF THIS REPORT THE PATIENT IS ALIVE. THE PIPELINE WAS USED FOR AN INDICATION THAT IS OFF-LABEL, SPECIFICALLY A M1/M2 BIFURCATION ANEURYSM AROUND A PREVIOUSLY PLACED ANEURYSM CLIP. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A 6F BMX96 LEFT FEMORAL SHEATH, PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND SYNCHRO14 GUIDEWIRE.

  Patient problems: Cerebral Edema; Confusion/ Disorientation; Intracranial Hemorrhage; Muscle Weakness/Atrophy

  MAUDE report 18325531 ↗
• MalfunctionApr 14, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS GOING TO BE TOO LONG AFTER 2/3 OF THE DEVICE HAD BEEN DELIVERED. THE PIPELINE WAS SU CCESSFULLY REMOVED AND A SHORTER 400X16 PIPELINE WAS SUCCESSFULLY USED WITHOUT ISSUE. THE DEVICE WAS NOT USED OFF-LABEL AND WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A 4MM NECK DIAM ETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS 93. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED EXCELLENT APPOSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-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-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-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