PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000284053), received between Mar 22, 2024 and Dec 10, 2025 — classified as 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Break; Retraction Problem; Unintended Movement; Physical Resistance/Sticking; Break; Retraction Problem; Unintended Movement; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROVASCULAR FLOW DIVERSION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY USING A PIPELINE FLEX SHIELD 3.25MM X 12MM DEVICE. DURING THE PROCEDURE, THE TIP OF THE DELIVERY WIRE FRACTURED AT THE PROXIMAL MARKER BAND LOCATION, RESULTING IN A BROKEN SEGMENT OF THE PUSHWIRE (WITH THE TIP COIL DETACHED) REMAINING IN THE PATIENT'S INTERNAL CAROTID ARTERY. SEVERE FRICTION AND DIFFICULTY WERE ENCOUNTERED DURING BOTH DELIVERY AND RETRIEVAL THROUGH THE PHENOM 27 MICROCATHETER. THE PIPELINE DEVICE FELL SHORT OF COMPLETELY COVERING THE ANEURYSM NECK, NECESSITATING THE USE OF A SECOND PIPELINE DEVICE TO ACHIEVE COMPLETE COVERAGE AND TO TRAP THE FRAGMENTED WIRE, PREVENTING MIGRATION. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. ANGIOGRAPHIC IMAGING POST-PROCEDURE SHOWED GOOD STASIS OF THE ANEURYSM AND CONFIRMED THAT THE FRACTURED DELIVERY WIRE WAS TACKED DOWN WITH THE SECOND PIPELINE DEVICE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE FRACTURED WIRE BEFORE FURTHER ATTEMPTS WERE HALTED. THE PATIENT WOKE WITH NO APPARENT HARM. NO PATIENT SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE

  Patient problems: Foreign Body In Patient

  MAUDE report 23768200 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED BRUISING. NO HOSPITALIZATION OR ADDITIONAL SURGICAL INTERVENTION WAS REPORTED. THE PATIENT WAS NOT RECOVERED/RESOLVED. IT WAS NOTED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE PATIENT EXPERIENCED AN EASE OF BRUISING SPECIFICALLY IN THE LEFT GROIN AND INTO THE THIGH. THERE WAS NO REPORTED TREATMENT GIVEN DUE TO THE BRUISING. THE SITE ASSESSMENT OF THE EVENT INDICATED THE EVENT WAS PROBABLY RELATED TO ANTIPLATELET MEDICATION. THE PATIENT WAS BEING TREATED FOR A RIGHT C6 ICA ANEURYSM WITH A SACCULAR MORPHOLOGY. LOCATION OF ANEURYSM WAS IN THE SIDEWALL OF THE VESSEL. ANEURYSM DIMENSIONS: MAXIMUM DIAMETER 6.8 MM, DOME HEIGHT 6.8 MM, DOME WIDTH 4.7 MM, NECK SIZE: 3.5 MM, PARENT ARTERY DIAMETER DISTAL TO ANEURYSM 3.5 MM AND PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM 4.1 MM. NO STASIS WAS NOTED AT THE END OF THE PROCEDURE. POST IMPLANT COMPLETE NECK COVERAGE WAS OBTAINED. POST IMPLANT THE ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROCEDURE WAS CLASS 3. THE PATIENT WAS BEING TREATED FOR ONE ANEURYSM WITH ACCESS VIA THE FEMORAL RIGHT. RIST WAS NOT USED. THE STUDY DEVICE WAS SUCCESSFULLY I

  Patient problems: Bruise/Contusion; Hearing Impairment; Stenosis; Unspecified Nervous System Problem

  MAUDE report 21648143 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THERE IS A FINDING FOR "RIGHT GROIN BRUISING/ECHYMOSIS" ON PROGRESS NOTE (B)(6) 2024 . PER PROCEDURE CRF, FINAL ACCESS WAS VIA RIGHT FEMORAL ARTERY. THEREFORE, THIS FINDING IS A POSSIBLE ACCESS SITE HEMORRHAGE COMPLICATION (WHICH IS CONSIDERED PROCEDURE RELATED). IT WAS UNKNOWN IF THERE WAS AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR, SPONSOR, OR CLINICAL EVENTS COMMITTEE. ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT WAS POSSIBLY RELATED TO ANTIPLATELET TREATMENT AND INDEX PROCEDURE. NO ADDITIONAL TREATMENT FOR BRUISING. THE EVENT WAS NOT LIFE-THREATENING. THE PATIENT WAS NOT HOSPITALIZED FOR BRUSING. PATIENT HAD A VASOSPASM THAT CAUSED HOSPITALIZATION.THE EVENT DID NOT RESULT IN PATIENT DISABILITY.

  Patient problems: Bruise/Contusion; Headache; No Clinical Signs, Symptoms or Conditions; Stenosis; Vasoconstriction

  MAUDE report 20849067 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AN INFINITY 088 GUIDE CATHETER, NAVIEN 058 INTRACRANIAL SUPPORT CATHETER, AND PHENOM 27 MICROCATHETER WERE USED IN THE PROCEDURE.

  Patient problems: Bradycardia; Bruise/Contusion; Headache; Stenosis; Vasoconstriction

  MAUDE report 20422228 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH 2 PED2 PIPELINES HAD COMPLICATIONS. SOURCE DOCUMENT REPORTED THE FOLLOWING FINDINGS ON THE DAY OF INDEX HOSPITAL DISCHARGE: HEMATURIA AND POSITIVE TEST FOR UTI. ANTIBIOTIC WAS GIVEN - RASH ON ABDOMEN AND BACK POSSIBLY DUE TO DRUG REACTION. STEROID CREAM WAS PRESCRIBED - FEMORAL DISSECTION: POSSIBLY ACCESS SITE, CONSERVATIVE FOLLOW UP ATRIAL FIBRILLATION WHICH WAS RESOLVED AND MEDICATION WAS NOT PRESCRIBED AT THIS MOMENT DUE TO RISK OF HEMORRHAGE. PLANNED TO WAIT FOR 2 WEEKS AFTER STROKE EVENT ON (B)(6) 2024. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Atrial Fibrillation; Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Skin Discoloration; Vascular Dissection

  MAUDE report 19085666 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ADVERSE EVENT TERM WAS UPDATED. NIHSS 24 AT ADMISSION AND 9 AT 24 HOURS POST EVENT AND 7 AT DISCHARGE. THE SITE ASSESSED AS CAUSALLY RELATED TO RELATIONSHIP TO ANTIPLATELET THERAPY, SWITCHED TO DAPT. FURTHER INFORMATION WAS RECEIVED THAT PER AVAILABLE INFORMATION, PATIENT WAS DISCHARGED ON (B)(6) 2024 TO REHAB. THEN, ADMITTED AGAIN DUE TO DISCUSSED SYMPTOMS ON (B)(6) 2024. HOSPTIALIZATION ENDED ON (B)(6) 2024. THE PATIENT EXPERIENCED ALTERED, RIGHT SIDED WEAKNESS, RIGHT SIDED FACIAL DROOP AND APHASIA RELATED TO THE STROKE. CT SCAN REPORTED INTRACEREBRAL VASCULAR OCCLUSION IN TREATED VASCULAR TERRITORY. A BENCHMARK CATHETER WAS USED. IT WAS UPDATED THAT THE REASON THE DEVICE WAS NOT IMPLANTED WAS DUE TO DEVICE MALFUNCTION.

  Patient problems: Aphonia; Hemorrhagic Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion; Ptosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 18964156 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED CEC ADJUDICATION 22JAN2025: CAUSALLY RELATED TO THE STUDY DEVICE.

  Patient problems: Aphonia; Hemorrhagic Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion; Ptosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 18964050 ↗

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-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-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