PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000284664), received between Sep 14, 2023 and Jan 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 16, 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.

• MalfunctionJan 6, 2026Positioning Failure; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT DURING DELIVERY AND POSITIONING, ADVANCEMENT THROUGH THE MICROCATHETER REQUIRED INCREASED FORCE, PARTICULARLY WHEN PASSING THROUGH TORTUOUS VASCULAR SEGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985947 ↗
• MalfunctionDec 8, 2025Structural Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation; Structural Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 12.7MM AND A 6.3 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.9MM DISTALLY AND 4.6MM PROXIMALLY. IT WAS REPORTED THAT UNDER GUIDEWIRE GUIDANCE, THE PHENOM 27 CATHETER FORMED A LOOP WITHIN THE ANEURYSM AND WAS THEN ADVANCED INTO THE DISTAL PARENT VESSEL, FOLLOWED BY THE INTERMEDIATE CATHETER. AFTER UNLOOPING, THE FIRST STENT (475-35) WAS SELECTED AND DEPLOYED SUCCESSFULLY. SLIGHT DISTAL SHORTENING WAS OBSERVED, RAISING CONCERNS ABOUT DISTAL ANCHORING. THEREFORE, IT WAS DECIDED TO PLACE AN ADDITIONAL DENSE MESH STENT AS A BRIDGE. UNDER GUIDEWIRE GUIDANCE, THE MICROCATHETER WAS ADVANCED THROUGH THE FIRST DENSE MESH STENT, AND THE DEPLOYMENT OF THE SECOND DENSE MESH STENT WAS INITIATED. HOWEVER, THE SECOND STENT COULD NOT BE OPENED AT THE DISTAL SECTION DESPITE VARIOUS MANEUVERS SUCH AS MANIPULATION AND REPOSITIONING. THE DENSE MESH STENT WAS THEN RETRIEVED AND REMOVED FROM THE BODY. AFTER REPLACING IT WITH A NEW STENT, THE PROCEDURE WAS COMPLETED SUCCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743446 ↗
• MalfunctionSep 15, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DISTAL END FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 13 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE WAS 3.5 MM DISTALLY AND 4.7 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. ASPIRIN 75 AND TICAGRELOR 90 WERE TAKEN CONTINUOUSLY FOR FOUR DAYS BEFORE SURGERY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS A GIANT OPHTHALMIC ARTERY ANEURYSM. IT WAS REPORTED THAT THE PHENOM27 CATHETER WAS USED TO DELIVER THE STENT INTO PLACE. DURING THE DEPLOYMENT PROCESS, THE STENT TIP DID NOT OPEN. THE SURGEON CONTINUED TO DEPLOY THE STENT. AFTER DEPLOYING ABOUT 10MM, THE DISTAL END OF THE STENT STILL COULD NOT OPEN. THE PROXIMAL AND MIDDLE ENDS HAD BEEN GRADUALLY OPENED. THE SURGEON CONTINUED TO DEPLOY ABOUT 7MM, BUT THE STENT TIP STILL COULD NOT OPEN. FOR THE SAKE OF SURGICAL SAFETY, THE SURGEON PUSHED THE HIGH-27 MICROCATHETER, RETRIEVED THE STENT, AND DEPLOYED IT AGAIN, BUT THE TIP END STILL COULD NOT OPEN. THE SURGEON RETRIEVED THE STENT AND REMOVED IT FROM THE BODY. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058798 ↗
• MalfunctionSep 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PARENT BLOOD FLOW OF THE ANEURYSM WAS DISRUPTED AND THERE WAS A LARGE AXIAL DEVIATION, SO IT TOOK APPROXIMATELY 40 MINUTES TO REACH THE DISTAL PART OF THE ANEURYSM. AT FIRST, PHENOM 27 WAS USED, BUT AS IT WAS NOT POSSIBLE TO REACH THE DISTAL PART, IT WAS REPLACED WITH SL-10 AND REACHED THE TARGET. AFTER PHENOM 27/THE RELEVANT PRODUCT REACHED THE DISTAL PART OF THE ANEURYSM, AN EVENT OCCURRED WHEN AN ATTEMPT WAS MADE TO REMOVE AND DEPLOY THE SLEEVE IN THE MIDDLE PART OF THE MIDDLE CEREBRAL ARTERY. WHEN THE SURGEON USED WIRE PUSHING TO BRING OUT HALF OF THE DISTAL COIL, COMMENTED THAT THEY FELT A RESISTANCE STRONGER THAN ANYTHING HAD EVER EXPERIENCED BEFORE. THE TIP COIL WAS STORED IN THE PHENOM 27 ONCE, AND THE SYSTEM WAS TRIED TO PUSH AGAIN, BUT THE RESISTANCE DID NOT CHANGE. DESPITE AN ATTEMPT TO PUSH THE WIRE QUITE STRONGLY, THE TIP COIL WOULD NOT ADVANCE, AND AS IT SEEMED UNSAFE TO CONTINUE THE PROCEDURE, THE PHENOM 27 AND THE RELEVANT PRODUCT WERE REMOVED. THE SURGEON COMMENTED THAT THERE WAS A PROBLEM WITH PHENOM 27 OR THE PRODUCT. DISTAL PART ANEURYSMS WERE REMOVED AGAIN USING ANOTHER LOT OF PHENOM 27, SYNCHRO SELECT STANDARD, AND ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967818 ↗
• MalfunctionSep 14, 2023Positioning Failure; Material Twisted/Bent; Activation Failure; Positioning Failure; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL PART OF THE PIPELINE WOULD NOT OPEN. MULTIPLE ATTEMPTS TO MAKE ADJUSTMENTS TO THE PIPELINE. IT LOOKED LIKE THE DISTAL END OF THE DEVICE WAS ENTANGLED TO ITSELF. THERE WAS MOVEMENT DURING PLACEMENT. THERE WERE NOT MULTIPLE PIPELINES BEING USED WHEN THE MOVEMENT OCCURRED. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE PIPELINE DID NOT MISSING THE LANDING ZONE AND DID NOT JUMP DURING THE DEPLOYMENT. THE PIPELINE WAS DEPLOYED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE. THE SIDE BRANCHES WERE NOT COVERED BY THE PIPELINE. THE MIDDLE AND DISTAL PARTS OF THE PIPELINE WERE POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. 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). 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 LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DI AMETER OF 20MM. THE LANDING ZONE ARTERY SIZE WAS 3.4

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17748900 ↗

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-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-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-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