Pipeline TM Flex Embolization Device with Shield Technology TM PED2-450-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000449377), received between Jan 6, 2026 and Sep 25, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Twisted/Bent; Packaging Problem; Activation Failure

  Medtronic received a report that on (b)(6)2026, the outer packaging of the Pipeline stent was intact. After the package was opened, the stent was found twisted and difficult to deploy before use. The procedure was completed after replacement with a new flow-diverting stent. There was no harm reported. No patient symptoms or complications associated with this event were reported. Event cause analysis was performed by the user, who described it as follows: the flow-diverting stent had a precision fine-mesh structure. During manufacturing, slight tolerances existed in the stent braiding density and wire tension, and outgoing quality-control screening was insufficient, resulting in substandard elastic recoil and structural stability in some stents. During packaging and transportation, even when the outer packaging remained intact, the stent could be slightly compressed inside the delivery sheath, which could lead to internal structural distortion and pre-deformation and prevent it from deploying normally and uniformly during the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897428 ↗
• MalfunctionSep 3, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Material Deformation; Material Twisted/Bent; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50587300 ↗
• MalfunctionMar 19, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT'S TIP END FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.7 MM AND A 4.5 MM NECK DIAMETER. THE LANDING ZONE WAS 4.6 MM DISTALLY AND 4.4 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS "PATENT VESSELS." IT WAS REPORTED THAT DURING TREATMENT OF A RA'B OPHTHALMIC SEGMENT ANEURYSM, THE TIP END OF THE STENT FAILED TO OPEN. MULTIPLE ATTEMPTS WERE MADE TO RECAPTURE AND REDEPLOY IT, BUT THE STENT STILL COULD NOT BE OPENED. AFTER SWITCHING TO ANOTHER STENT, THE PROCEDURE PROCEEDED SMOOTHLY. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639423 ↗
• MalfunctionJan 6, 2026Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED. IT WAS CLARIFIED THAT THE MICROCATHETER WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983623 ↗

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-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-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