PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000284046), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE HAD CLOTTED VESSELS. PIPELINE PLACED DISTALLY IN LEFT POSTERIOR CEREBRAL ARTERY (PCA), COVERING ANEURYSM SUPERIOR TO LEFT SUPERIOR CEREBELLAR ARTERY (SCA), AND PLACED INTO THE DISTAL BASILAR. POST PLACEMENT, THREE WEEKS OUT, THE PATIENT DEVELOPED STROKE SYMPTOMS. UPON ANGIOGRAPHIC FOLLOW-UP, CLOT WAS SEEN ON THE OUTER EDGES OF THE DEVICE AT THE ORIGIN OF THE RIGHT PAC AND LEFT SCA. THE PIPELINE WAS USED FOR AN INDICATION THAT WAS NOT APPROVED. POSTERIOR CIRCULATION. PHYSICIAN TRIED WEB FIRST, BUT WAS UNSUCCESSFUL. DECIDED TO USE PIPELINE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE BASILAR LOCATION BETWEEN LEFT PCA AND SCA. THE MAX DIAMETER IS 4.5MM AND THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 2.2MM AND THE PROXIMAL LANDING ZONE WAS 3.2MM. VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. PRU LEVELS WAS WITHIN NORMAL LIMITS. THE PATIENT HAD A STROKE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15201890 ↗

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-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-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-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