PIPELINE PED-450-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536016538), received between Oct 9, 2018 and Nov 14, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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, 2021Class IOpen, 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.

• MalfunctionNov 14, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP END OPENED SMOOTHLY OF THE PIPELINE, BUT THE STENT COULD NOT BE OPENED AT THE SIPHON BENDING SECTION. THE OPERATION WAS REPEATED, HOWEVER, THE STENT WAS TOO LONG AND NEEDED TO CROSS TWO BENDS. THE PIPELINE WAS REPLACED AND THE OPERATION WAS COMPLETE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN IF A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SLOWED BLOOD FLOW AND RETENTION IN THE TUMOR. THE PIPELINE AND ACCESSORY DEVICES WERE NOT USED OFF-LABEL AND WAS PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808640 ↗
• MalfunctionJan 8, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN AND HAD BEEN PLACED IN STRAIGHT BLOOD VESSELS. ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE INCLUDED TRYING TO RETRIEVE IT AND DEPLOY IT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140910 ↗
• MalfunctionDec 30, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE WAS PLACED IN A STRAIGHT BLOOD VESSEL, BUT IT STILL COULD NOT BE OPENED. AFTER THE STENT FAILED TO OPEN, IT WAS PULLED BACK TO THE EXPECTED ANCHORING POSITION, BUT THE PIPELINE WAS STILL UNABLE TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094953 ↗
• MalfunctionSep 14, 2020Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE, AND BOTH THE PIPELINE AND MICROCATHETER WERE DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4.3MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, BUT THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN. IT WAS REPORTED THAT AFTER DEPLOYING THE PIPELINE, THE STENT COULD NOT BE OPENED IN THE MIDDLE AND WAS KINKED AT THE CORNERS AFTER THE TIP WAS OPENED AND ATTACHED TO THE VESSEL WALL. AFTER SEVERAL ATTEMPTS AT DEPLOYMENT, THE STENT WAS STILL KINKED. IT WAS NOTED THE DEVICE WAS NOT POSITIONED IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS DONE MORE THAN TWICE, AND NO ADDITIONAL STEPS WERE PERFORMED TO OPEN THE PIPELINE. IT WAS STATED THAT THE PIPELINE WAS NOT REMOVED FROM THE PATIENT AND FULL WALL APPOSITION WAS ACHIEVED, BUT IT WAS ALSO STATED THE DEVICE FAILED TO OPEN AND THE PIPELINE WAS REMOVED FROM THE PATIENT. UPON REMOVAL, IT WAS FOUND THE MARKSMAN MICROCATHETER WAS DAMAGED IN THE MIDDLE S

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10528349 ↗
• MalfunctionDec 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT RESISTANCE WAS FELT WHEN THE PIPELINE FLEX WAS ALLEGED TO HAVE FAILED TO OPEN IN THE MIDDLE SECTION. THE MICROCATHETER WAS DELIVERED IN TO THE DISTAL END OF M1, DELIVERED THE PIPELINE IN PLACE. DURING THE DELIVERY, THE SURGEON FELT A LARGE RESISTANCE, AND THEN RELEASED IT. AFTER RELEASING A CERTAIN DISTANCE, HE WANTED TO RETRIEVE THE MICROCATHETER TO OPEN THE PROTECTIVE SLEEVE, BUT FOUND THAT IT COULD NOT BE RETRIEVED ANYMORE, ONLY THE WHOLE WITHDRAWN TO THE INNER END OF THE NECK TO OPEN THE DISTAL END OF THE STENT AND CONTINUED TO RELEASE IT AFTER OPENING. IT WAS FOUND THAT IT COULD NOT BE RELEASED ANYMORE AT THE MIDDLE. REPEATED ATTEMPTS TO RETRIEVE BUT STILL FAILED. FINALLY, THE OVERALL SYSTEM COULD ONLY BE WITHDRAWN. IT WAS FOUND THAT THE DISTAL PORTION OF THE MICROCATHETER HAD BEEN WRINKLED AND COULDN'T BE USED NORMALLY. THE END OF THE STENT HAS FLUFFED DUE TO MULTIPLE OPERATIONS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER THE IFU. NO PATIENT INJURY OCCURRED. THIS EVENT OCCURRED DURING THE TREATMENT OF A GIANT ANEURYSM OF THE RIGHT, UNRUPTURED, INTERNAL CAROTID ARTERY IN THE CAVERNOUS -

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415724 ↗
• MalfunctionAug 1, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE TIP COULD NOT BE OPENED, EVEN AFTER REPEATED ADJUSTMENTS. AS A RESULT THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8852653 ↗
• MalfunctionOct 16, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, WITH IT RESHEATED LESS THAN OR EQUAL TO 2 TIMES. AS A RESULT THE PIPELINE WAS REMOVED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A RUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 13MM AND A NECK DIAMETER OF 7MM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL AND THAT THE PIPELINE WAS NOT POSITIONED IN A BEND. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. ANCILLARY DEVICES INCLUDES A 9F COOK SHEATH, MARKSMAN, ECHELON MICROCATHETER, X-PEDION GUIDEWIRE, AND AXIUM COILS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7968990 ↗
• MalfunctionOct 9, 2018Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX DEVICES GOT DAMAGED AND WOULD NOT TRACK INTO THE TARGET AREA FOR PLACEMENT. IT WAS STATED THAT WHILE PUSHING THE FIRST PIPELINE THERE WAS HUGE RESISTANCE IN THE DISTAL END CAUSING IN INABILITY TO TRACK/DEPLOY TO THE POINT THAT THE PHYSICIAN COULDN'T MOVE IT EVEN AFTER USING VARIOUS STANDARD RESCUE TECHNIQUES LIKE REMOVING SLACK, AND PUSHING THE CATHETERS FURTHER FOR BETTER PROXIMAL SUPPORT. THE DEVICE WAS THEN TAKEN OUT OF THE PATIENT'S BODY WHICH SHOWED THAT THE DISTAL PART OF THE PIPELINE WAS CRAMPED. AS A RESULT ANOTHER PIPELINE WAS USED BUT THE ISSUE PERSISTED, SO IT WAS REMOVED AGAIN AND THE PATIENT TREATED WITH BALLOON ASSISTED COILING. IT WAS NOTED THAT THERE WAS STRETCH DAMAGE ON THE DISTAL END OF THE PIPELINE. PRIOR TO THE ISSUE 4 COILS HAD BEEN SUCCESSFULLY DEPLOYED. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A SACCULAR, RUPTURED, OPTHALMIC ANEURYSM WITH A MAX DIAMETER OF 19MM AND A NECK DIAMETER OF 6MM. THE DEVICES WERE PREPARED/FLUSHED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A NEURON MAX GUIDE CATHETER, SCEPTER-C AND ECHELON 10, AND SYNCRO/AXIUM COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949025 ↗

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-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-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-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-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