PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000284183), received between Jan 15, 2025 and Nov 3, 2025 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionNov 3, 2025Break; Positioning Failure; Retraction Problem; Unintended Movement; Migration; Physical Resistance/Sticking; Break; Positioning Failure; Retraction Problem; Unintended Movement; Migration; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. MIGRATION OCCURRED BECAUSE THE STENT RETRACTED DURING THE OPENING PROCESS. THE CAUSE OF THE DELIVERY WIRE DETACHMENT WAS DUE TO UNLOADING BETWEEN THE RUBBER PAD AND THE STENT. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION, AND NO DAMAGE SUCH AS BREAK OR KINK WAS OBSERVED. RESISTANCE WAS ENCOUNTERED WHEN RETRIEVING THE STENT AFTER MIGRATION WAS NOTED, AND THE DELIVERY WIRE DETACHED DURING RETRIEVAL. NO VISIBLE DAMAGE OR DEFORMATION WAS FOUND ON THE STENT OR MICROCATHETER AFTER REMOVAL, AND ALL COMPONENTS WERE RETRIEVED INTACT WITH NOTHING LEFT INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR INTERVENTIONS AS A RESULT OF THIS EVENT, AND NO VESSEL INJURY, DISSECTION, OR OTHER INTRAOPERATIVE COMPLICATION WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23454474 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A PIPELINE VANTAGE TO TREAT A BRAIN ANEURYSM IN THEIR LEFT CAROTID ARTERY. THE PROCEDURE WAS EXECUTED WITHOUT INCIDENT. PLAVIX, ASPIRIN AND DEXAMETHASONE PRESCRIBED FOR 3 MOS, 3 MOS, AND 1 WEEK, RESPECTIVELY. AFTER ONE WEEK OF BEING OFF THE STEROIDS, THE PATIENT WENT INTO THE ER WITH STROKE-LIKE SYMPTOMS, INCLUDING RIGHT-SIDE ARM LACK OF RESPONSIVENESS. IN THE ER, SYMPTOMS PROGRESSED TO RIGHT FACE DROOPING AND INABILITY TO FORM SENTENCES. COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING REVEALS FLUID-ATTENUATED INVERSION RECOVERY, BUT OCCURRING PREVIOUS TO THE CURRENT INCIDENT. IT WAS CONCLUDED THE EVENT RESULTED IN A STROKE WHICH HAPPENED AT POINT OF PROCEDURE OR SHORTLY THEREAFTER. UPON FURTHER CONSULTATION, THE PHYSICIANS CONCURRED THESE WERE NICE (NON-ISCHEMIC CEREBRAL ENHANCING) LESIONS, LIKELY FORMED AS A RESULT OF SHEERING DURING DEVICE IMPLANT, WITH POLYMER COATING NOW IRRITATING BRAIN TISSUE IN FOUR AREAS. THE PATIENT STAYED THE NIGHT AND WAS PRESCRIBED PREDNISONE, ANTI-VIRALS AND ANTIBIOTICS, AND WAS SENT HOME. THE PATIENT RETURNED AGAIN WITH STROKE SYMPTOMS. ANOTHER MRA AND CT REVEALED SMALLER LESIONS AND NO NEW LESIONS. PREDNISONE COURSE WAS SHORT

  Patient problems: Anxiety; Dysphasia; Facial Paralysis; Headache; Ischemia Stroke; Paralysis

  MAUDE report 21317561 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A PIPELINE FLEX SHIELD 3.50MM X 20MM FOR A LEFT SUPERIOR HYPOTHOSEAL SACCULAR ANEURYSM, THE PATIENT EXPERIENCED NUMBNESS ON THE RIGHT SIDE, TRANSIENT EPISODES OF RIGHT-SIDED HAND WEAKNESS, SPEECH ISSUES, RIGHT HAND NUMBNESS AND WEAKNESS, AND RIGHT FACIAL NUMBNESS. MAGNETIC RESONANCE IMAGING (MRI) REVEALED MULTIPLE T2 HYPERINTENSE FOCI THROUGHOUT THE LEFT CEREBRAL HEMISPHERE WITH POST-CONTRAST ENHANCEMENT, CONSISTENT WITH NON-ISCHEMIC CEREBRAL ENHANCING LESIONS (NICE EVENT). THE PATIENT WAS ADMINISTERED DUAL ANTIPLATELET TREATMENT WITH PLAVIX AND ASPIRIN, AS GENETIC TESTING INDICATED RESPONSIVENESS. STEROIDS WERE INITIATED AS AN INTERVENTION. FOLLOW-UP MRI SHOWED A DECREASE IN SIZE AND ENHANCEMENT OF MULTIPLE FOCAL FLAIR LESIONS. THE ANGIOGRAPHIC RESULT POST-PROCEDURE INDICATED THAT EVERYTHING APPEARED SATISFACTORY FOLLOWING THE PLACEMENT. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WENT WITHOUT INCIDENT ON (B)(6) 2024 BUT ONCE OFF STEROIDS ENDED UP IN ER WITH STROKE SYMPTOMS THIS CONCLUDED WITH DIAGNOSIS OF NON-ISCHEMIC LESIONS LOCATED IN 4 PLACES LIKELY DUE TO SEARING OF THE

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Numbness; Speech Disorder

  MAUDE report 21158464 ↗

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-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-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