PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000283940), received between Sep 5, 2023 and Sep 15, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THIS PATIENT WAS TREATED FOR AN ANEURYSM USING A FLOW-DIVERTING DEVICE. AFTER THE PIPELINE STENT WAS DELIVERED TO THE TARGET POSITION THROUGH THE PHENOM27 MICROCATHETER, DEPLOY OF THE STENT WAS INITIATED AT THE STRAIGHT SEGMENT. HOWEVER, IT WAS FOUND THAT THE TIP END OF THE STENT WAS STUCK AT THE TIP OF THE MICROCATHETER AND COULD NOT BE DEPLOYED NORMALLY, NOR COULD THE STENT BE RETRIEVED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057285 ↗
• MalfunctionJul 7, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED RESISTANCE WAS ENCOUNTERED WHILE RETRACTING INTO THE CATHETER. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A LVIS STENT. CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO CATHETER OR PIPELINE PUSHWIRE DAMAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419950 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE HAD ASPIRATION PNEUMONIA. COURSE FURTHER COMPLICATED BY A SPIRATION PNEUMONIA, TREATED WITH IV ZOSYN AND TRANSITION TO PO AUGMENTIN (END OF TREATMENT (B)(6)). (B)(6) CXR--> DHT TERMINATES IN PROXIMAL ESOPHAGUS/TRACHEA AND THERE IS A RIGHT MIDDLE LOBE (RML) OPACITY C/F INFECTION VS ASPIRATION TOXIC/METABOLIC ENCEPHALOPATHY AND LEUKOCYTOSIS DUE TO ASPIRATION PNEUMONIA. TREATED WITH IV ZOSYN AND TRANSITION TO PO AUGMENTIN. THE EVENT RESOLVED ON (B)(6) 2024. IT DID NOT RESULT IN HOSPITALIZATION. THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Aspiration/Inhalation; Bacterial Infection

  MAUDE report 19969295 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT CEC ASSESSED AS SAE CAUSALLY RELATED TO INDEX PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE AND APT. PER CEC IT IS A MINOR ISCHEMIC STROKE IN TREATED VASCULAR TERRITORY. CORELAB REVIEWED THE NCCT IMAGES TAKEN ON (B)(6) 2024 AND REPORTED "NEW HEMORRHAGE ALONG PRIOR EVD TRACT WITH NEW SMALL INTRAVENTRICULAR HEMORRHAGE." SITE HAS ALREADY REPORTED THE STROKE EVENT POST PROCEDURE.

  Patient problems: Cognitive Changes; Ischemia Stroke; Stroke/CVA

  MAUDE report 19568785 ↗
• MalfunctionSep 5, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDEWIRE OF THE PIPELINE SHIELD STENT WAS BROKEN AND STUCK DURING DELIVERY. THE PUSHWIRE BROKE IN THE MIDDLE SECTION. THE PHENOM CATHETER EXPERIENCED RESISTANCE IN THE MIDDLE SECTION OF THE CATHETER. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHENOM CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED AN INTRACRANIAL ANEURYSM. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED INTRACRANIAL SEGMENT OF THE INTERNAL CAROTID ARTERY ANEURYSM. THE PATIENT ALSO UNDERWENT A BLOOD FLOW DIVERSION STENT IMPLANTATION. THE PATIENT'S ACCESS VESSEL WAS THE FEMORAL ARTERY. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687171 ↗

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-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-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-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-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-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