Pipeline TM Flex Embolization Device with Shield Technology TM PED2-475-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000449469), received between Nov 14, 2025 and Sep 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733887 ↗
• MalfunctionApr 23, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER DEPLOYMENT OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY FLOW DIVERTING STENT, SEVERE KINKING WAS OBSERVED, AND THE STENT COULD NOT BE PROPERLY EXPANDED IN THE MIDDLE SECTION DESPITE MANUAL MANIPULATION. THE STENT WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE STENT WAS REPLACED WITH A NEW ONE OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.6 MM DISTALLY AND 4.9 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE PIPELINE WAS NOT POSITIONED IN A BEND, LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES, AND THERE WERE NO ADDITIONAL STEPS OR OT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966494 ↗
• MalfunctionMar 16, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, LEFT CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 4.2 MM DISTALLY AND 4.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AN INTRACRANIAL ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A LEFT INTERNAL CAROTID ARTERY ANEURYSM. THE OPERATOR SELECTED A PIPELINE SHIELD DENSE-MESH STENT. AFTER THE ACCESS WAS SUCCESSFULLY ESTABLISHED, THE STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. AFTER APPROXIMATELY 7¿8 MM OF THE DISTAL TIP END OF THE STENT WAS EXPOSED, A WAITING PERIOD OF ABOUT 10 SECONDS WAS OBSERVED; HOWEVER, THE DISTAL TIP END FAILED TO OPEN. THE STENT WAS THEN FURTHER DEPLOYED BY APPROXIMATELY 12 MM, BUT THE DISTAL TIP END STILL DID NOT OPEN. THE OPERATOR ATTEMPTED RESHEATHING AND REDEPLOYMENT. DESPITE MANEUVERS SUCH AS SHAKING, PUSHING, AND PULLING, THE DISTAL TIP END REMAINED UNOPENED. ADDITIONAL ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606170 ↗
• MalfunctionJan 7, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE FAILURE TO OPEN AND THE RESISTANCE WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988410 ↗
• MalfunctionDec 10, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE PROXIMAL MEASUREMENT IS 4.7 MM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PIPELINE DEVICE FAILED TO OPEN WHILE POSITIONED IN A VESSEL BEND. NO ADDITIONAL STEPS OR OTHER DEVICES (SUCH AS RESHEATHING, WIRE/CATHETER, OR BALLOON) WERE ATTEMPTED TO OPEN THE PIPELINE. NO ISSUES WERE REPORTED WITH EITHER THE NAVIEN CATHETER OR THE PHENOM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768230 ↗
• MalfunctionNov 14, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE ECHELON 10 TIP WAS KINKED AND NOT BROKEN. THE COIL LOOP DID NOT GO INGO THE PARENT VESSEL, MIGRATE POST DEPLOYMENT, HAVE POOR LAYUP OR FRAMING, OR ISSUES WITH THE SHAPE-LOOP-SIZE. THERE WAS NO CONCOMITANT DEVICE INVOLVED WITH THE MARKSMAN CATHETER RESISTANCE, THOUGH IT WAS NOTED THERE WAS RESISTANCE DURING DELIVERY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO EITHER PIPELINE PUSHWIRE OR CATHETER OBSERVED. THE PIPELINES HAD NOT BEEN POSITIONED IN A BEND WHEN THEY FAILED TO OPEN. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINES. THE CAUSE OF THE DAMAGE, RESISTANCE, NAVIGATION ISSUES, AND FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556940 ↗

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-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-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