PIPELINE PED-475-35 (UDI 00847536016835)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536016835), received between May 21, 2019 and Sep 24, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 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.

Recalls naming this device

1. Jul 13, 2021Open, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS RESISTANCE AT THE TIP END WHEN THE STENT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526282 ↗
• MalfunctionJul 30, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE DISTAL END A A PIPELINE DID NOT OPEN. AND REPEATED ADJUSTMENTS FAILED TO OPEN THE TIP END OF THE STENT. AFTER THE WHOLE SYSTEM WAS WITHDRAWN, IT WAS OPENED IN VITRO AND FOUND THAT THE TIP END OF PIPELINE WAS DAMAGED AND BIFURCATION OCCURRED, WHICH AFFECTED THE DEPLOYMENT IN THE BODY. THE PATIENT WAS BEING TREATED FOR UNRUPTURED SACCULAR LEFT OCULAR ANEURYSM. THE MAX DIAMETER WAS 20 MM AND THE NECK DIAMETER WAS 17.5 MM. THE ARTERY LANDING ZONEWAS 4.92 MM PROXIMAL AND 4.41 MM DISTAL. VESSEL TORTUOSITY WAS SEVERE.  IT WAS INDICATED THE PIPELINE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INDICATION FOR USE. AFTER THE PIPELINE WAS REMOVED. REPLACED THE STENT AND CONTINUED TO DEPLOY. AFTER THE DEPLOYMENT WAS SUCCESSFUL, CONTINUED TO SELECT THE STENT FOR BRIDGING DEPLOYMENT THERAPY. AFTER THE DEPLOYMENT WAS SUCCESSFUL, THE GUIDE WIRE AND CATHETER WERE WITHDRAWN TO END THE TREATMENT. THE PIPELINE WAS NOT POSITIONED IN A BEND. NO PATIENT SYMPTOMS WERE REPORTED. ACCESSORY DEVICES: 6F NAVIEN, PHENOM27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256156 ↗
• MalfunctionJul 29, 2021Break; Retraction Problem; Break; Retraction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DISTAL FLEXIBLE SECTION OF THE CATHETER HAD RESISTANCE. THE DELIVERY WIRE AND CATHETER ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249746 ↗
• MalfunctionJul 6, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND AT THE TIME OF DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125411 ↗
• MalfunctionMay 27, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END AND HAD RESISTANCE IN THE DISTAL END OF THE PHENOM MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF A CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 17MM AND THE NECK DIAMETER WAS 11MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). WHEN DELIVERED, THE DISTAL END OF THE PIPELINE COULD NOT BE OPENED NORMALLY AFTER REPEATED ATTEMPTS. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO OTHER ADDITIONAL STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINE. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE PHENOM 27 MICROCATHETER. IT WAS NOTED THERE WAS RESISTANCE IN THE DISTAL END OF THE MICROCATHETER. BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: 6F LONG SHEATH, 5F NAVIEN 115 CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894887 ↗
• InjuryMay 22, 2020Break; Positioning Failure; Break; Positioning Failure

  MEDTRONIC RECEIVED INFORMATION THAT PUSHWIRE OF PIPELINE FLEX BROKE DURING THE PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY (ICA) ANEURYSM LOCATED IN CAVERNOUS SEGMENT. MEASURING 18MMX4MM, LANDING ZONE DISTAL 4.9MM PROXIMAL 4.8MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT DUE TO A NARROWING OF THE CERVICAL CAROTID, THE PHYSICIAN GAVE NITRO. THERE MAY HAVE BEEN A SMALL DISSECTION. IT WAS THOUGHT OF NOT DOING THE CASE. HE PROCEEDED. INITIALLY WENT IN WITH A 4.75X25 PIPELINE AND IT WAS NEARLY ALL THE WAY DEPLOYED, BUT WE HAD CONCERN THAT WHEN TRYING TO RUN THE MEDTRONIC CATHETER THROUGH IT MIGHT POP IN AND DROP IT INTO THE ANEURYSM. THUS, WE PULLED THAT OUT AND CHOSE A 4.75 X 35. THAT WAS MUCH WAGGING AND RECEIVING AND CENTERING, BUT ALL IN ALL THOUGH PIPELINE WAS DEPLOYING WELL AS. WE WERE APPROACHING THE POINT OF NO RETURN MARKER BANDS WHEN THE CATHETER CURLED UP LIKE A CANDY CANE. OUR FIX WAS TO MANEUVER THE MEDTRONIC DISTAL ACCESS SUPPORT CATHETER OVER THE CATHETER THUS STRAIGHTENING OUT THE CATHETER AND DEPLOY THE REST OF THE PIPELINE IN THE DISTAL ACCESS SUPPORT CATHETER. THIS ACTUALLY WO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10083482 ↗
• MalfunctionApr 1, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FRACTURES BEFORE IT WAS FULLY DEPLOYED. THE PHYSICIAN REMOVED THE DISTAL TIP WITH A SOLITAIRE, BUT IT WAS ALSO STATED THE DEVICE WAS IMPLANTED AND REMAINS IN SERVICE. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM IN AN OFF-LABEL LOCATION WITH A MAX DIAMETER OF 30 MM AND A 30 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL, AND POST-PROCEDURE ANGIOGRAPHIC RESULTS WERE VERY GOOD. ANCILLARY DEVICES INCLUDE A NEURON MAX, 5 MAXX, PHENOM 027, SYNCHRO GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9912054 ↗
• MalfunctionMay 21, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT IT WAS EXTREMELY HARD TO PUSH THE PIPELINE FLEX THROUGH THE CATHETER, AFTER WHICH THE TIP OF THE PIPELINE COULD NOT BE OPENED EVEN AFTER MAKING ADJUSTMENTS. AS A RESULT THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ICA ANEURYSM WITH A MAX DIAMETER OF 28MM AND A NECK DIAMETER OF 16.7MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THE PRU LEVEL WAS UNKNOWN. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED SLOW BLOOD FLOW. IT WAS NOTED THAT THE PATIENT HAD A SEVERE VESSEL TORTUOSITY. THERE WERE NO RELATED PATIENT SYMPTOMS. THE MICROCATHETER WAS IN A CURB IN THE ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8628915 ↗

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-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-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-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