PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000284565), received between Aug 15, 2023 and Dec 1, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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.

• MalfunctionDec 1, 2025Material Deformation; Material Twisted/Bent; Activation Failure; Physical Resistance/Sticking; Material Deformation; Material Twisted/Bent; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER ESTABLISHING ACCESS, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. AFTER EXPOSING APPROXIMATELY 7¿8 MM OF THE STENT TIP AND WAITING FOR ABOUT 10 SECONDS, THE TIP FAILED TO OPEN. THE STENT WAS DEPLOYED AN ADDITIONAL 12 MM, BUT THE TIP STILL DID NOT OPEN. ATTEMPTS WERE MADE TO RETRIEVE AND REDEPLOY THE STENT, AND VARIOUS MANEUVERS SUCH AS SHAKING AND PUSH-PULL TECHNIQUES WERE ALSO ATTEMPTED, HOWEVER, THE STENT TIP REMAINED UNOPENED. ADJUSTMENTS TO THE MICROCATHETER TENSION WERE ALSO INEFFECTIVE. THE STENT WAS WITHDRAWN FROM THE BODY, AND IT WAS FOUND THAT THE STENT TIP WAS ENTANGLED. THE STENT AND MICROCATHETER WERE REPLACED WITH MEDTRONIC PRODUCTS 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, SACCULAR, ANEURYSM OF THE LEFT CAROTID ARTERY WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 4.4 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. FEMORAL ARTERY ACCESS VESSEL DIAMET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686930 ↗
• MalfunctionOct 15, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT RESISTANCE WAS IN THE DISTAL END OF THE CATHETER. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303941 ↗
• MalfunctionAug 11, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE FLEX WITH SHIELD STENTS THAT FAILED TO OPEN. THE PATIENT, WHO HAD MULTIPLE ANEURYSMS IN THE INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT, WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A RUPTURED AMORPHOUS ANEURYSM. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS BELOW THE ICA BIFURCATION AND THE PROXIMAL LANDING ZONE WAS IN THE CAVERNOUS SINUS STRAIGHT SEGMENT. PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PIPELINES AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PER THE VESSEL MEASUREMENT, PED2-475-25 WAS SELECTED. THE STENT WAS DELIVERED IN THE M2 AND THE PIPELINE WAS DELIVERED. THE MICROCATHETER WAS WITHDRAWN UNTIL ABOUT 15MM OF THE PIPELINE STENT WAS EXPOSED, BUT THE PIPELINE DID NOT OPEN; THE TIP WAS ROD-SHAPED. THE DEVICE WAS PULLED BACK TO THE ICA AND DEPLOYMENT CONTINUED. THE TIP END WAS ABLE TO BE ANCHORED THEN BUT AT THE BEND OF THE OPHTHALMIC ARTERY, THE STENT AGAIN APPEARED ROD-SHAPED AND COULD NOT BE OPENED DESPITE PUSH AND PULL MANEUVERS. THE PIPELINE WAS REMOVED. A NEW MICROCATHETER WAS THEN USED TO DELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777333 ↗
• MalfunctionJul 22, 2025Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564517 ↗
• InjuryJun 10, 2025Flaked; Material Integrity Problem; Flaked; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS DOING OKAY. THE PATIENT WAS DISCHARGED BUT RETURNED TO THE EMERGENCY ROOM FOR SYMPTOMS ON (B)(6) 2025. PATIENT WAS ADMITTED AND ADMINISTERED IV STEROIDS.

  Patient problems: Bacterial Infection; Cognitive Changes; Dizziness; Embolism/Embolus; Emotional Changes; Foreign Body In Patient; Foreign Body Reaction; Headache; Hypersensitivity/Allergic reaction; Ischemia Stroke; Memory Loss/Impairment; Multiple Organ Dysfunction Syndrome; Pain; Visual Impairment

  MAUDE report 22178304 ↗
• MalfunctionAug 15, 2023Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING IN THE M1 AND DRAGGING THE DEVICE BACK IT ENDED UP TOO PROXIMAL SO THE PHYSICIAN RESHEATHED THE DEVICE AND TRIED AGAIN. THE SAME THING HAPPENED AGAIN SO HE RESHEATHED A SECOND TIME AND DECIDED TO DEPLOY FROM THE M1 DOWN INTO THE INTERNAL CAROTID ARTERY (ICA) BUT THE DEVICE WOULDN¿T OPEN UP DISTALLY SO THE PIPELINE HAD TO BE REMOVED. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS NOT STUCK IN THE CAPTURE COIL. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT. THE PHENOM 27 WAS LEFT IN THE M1 AND THE PIPELINE WAS PULLED OUT THROUGH THAT CATHETER. 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, RUPTURED ANEURYSM IN THE LEFT ICA WITH A MAX DIAMETER OF 16MM AND A 12MM NECK DIAMETER. THE LANDING ZONE WAS 3.6MM DISTALLY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549708 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• 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-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-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