PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000284268), received between Oct 19, 2021 and Aug 20, 2025 — 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.

• MalfunctionAug 20, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX SHIELD STENT THAT FAILED TO OPEN IN THE MIDDLE SEGMENT. THE PATIENT WAS UNDERGOING A PROCEDURE VIA FEMORAL ARTERY ACCESS FOR FLOW DIVERTER TREATMENT OF A POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE PHENOM 27 MICROCATHETER WAS IN PLACE, THE PIPELINE STENT WAS DEPLOYED. HOWEVER, THE MIDDLE SECTION OF THE STENT COULD NOT BE OPENED. RETRIEVAL AND REDEPLOYMENT WAS ATTEMPTED MULTIPLE TIMES BUT WAS UNSUCCESSFUL IN OPENING THE PIPELINE. THE PIPELINE AND PHENOM WERE WITHDRAWN TOGETHER AND BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED EXPECTED BLOOD RETENTION IN THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850001 ↗
• MalfunctionApr 25, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORT OF "PIPELINE WAS UNABLE TO BE REMOVED FROM THE MICROCATHETER" MEANT THAT THE PIPELINE HAD RESISTANCE DURING RETRIEVAL. THERE HAD BEEN RESISTANCE IN THE DISTAL END OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. IT WAS UNKNOWN WHEN PREMATURE DEPLOYMENT OCCURRED. IT WAS UNKNOWN IF THE PUSHWIRE WAS ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE. THE PIPELINE HAD BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE HAD BEEN AN ATTEMPT TO RETRIEVE AND THEN DEPLOY THE STENT IN ORDER TO OPEN THE PIPELINE. NO ATTEMPTS WERE MADE TO RESHEATH THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911465 ↗
• MalfunctionMar 10, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PIPELINE DID NOT OPEN IN THE DISTAL SECTION. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569259 ↗
• MalfunctionOct 19, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT PARAOPHLAMIC ARTERY WITH A 4MM NECK DIAMETER. THE LANDING ZONE WAS 3.56MM AT THE DISTAL END AND 3.8MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE FIRST PIPELINE SHIELD ATTEMPTED TO DEPLOY WAS THE (B)(4). DEPLOYMENT WAS SUCCESSFUL UNTIL THE LAST 1/4TH OF DEVICE. THE PATIENT HAD A HIGH AND TIGHT POSTERIOR GENU. THE PHYSICIAN UNLOADED SYSTEM AND LOADED SYSTEM MULTIPLE TIMES TO TRY AND OPEN AROUND THE GENU. THE PROXIMAL SECTION OF THE DEVICE WOULD NOT OPEN. HE DECIDED TO USE A SHORTER DEVICE. HE WENT TO RESHEATH THE PIPELINE WITH THE CORRECT 80% WIRE PULL 20% CATHETER PUSH AND THE DEVICE CAME OFF THE DELIVERY SYSTEM. FORTUNATELY, HE WAS ABLE TO ADVANCE THE NAVIEN 058 OVER THE PIPELINE AND PULLED THE ENTIRE SYSTEM OUT. HE GOT ACCESS AGAIN, THIS TIME CHANGING THE INTERMEDIATE CATHETER TO A PHENOM PLUS. HE ENCOUNTERED THE SAME PROBLEM ATTEMPTING TO OPEN THE PROXIMAL PORTION OF THE (B)(4). HE HAS TO LOAD AND UNLOAD MULTIPLE TIMES TRYING TO OPEN THE PROXIMAL END OF THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657615 ↗

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-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-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-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