PIPELINE PED-475-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536016620), received between Mar 11, 2019 and Sep 20, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 18, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WAS NOT OPENING. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN OPHTHALMIC, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 1.5MM AND A 3MM NECK D IAMETER. THE MORPHOLOGY INCLUDED A BLISTER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PHYSICIAN WENT TO DEPLOY THE PIPELINE 4.75 X 14 AND WAS NOTIFIED THE DISTAL END WAS NOT OPENING. IT WAS INDICATED THE MIDDLE AND PROXIMAL PARTS OF THE PIPELINE WERE POSITIONED IN A BEND. THE PHYSICIAN RECAPTURED THE DEVICE AND OPENED AGAIN, HOWEVER, THE DISTAL END WOULD NOT OPEN. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RE-SHEATHED MORE THAN TWO TIMES WITH THE MICROCATHETER. THE PRODUCT WAS REMOVED BY THE PHYSICIAN AND A PIPELINE 4.75 X 12 WAS INSERTED. THE 4.75 X 12 OPENED DISTORT, HOWEVER, DURING THE DEPLOYMENT THERE WAS RIBBONING IN THE MID-SECTION AND THE DEVICE WOULD NOT OPEN. A RECAPTURING OF THE DEVICE OCCURRED AND THE DEPLOYMENT WAS ATTEMPTED THREE TIMES BUT THERE WAS A RIBBONING IN THE SAME SECTION. ONCE AGAIN, MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494597 ↗
• MalfunctionJun 8, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963139 ↗
• MalfunctionJun 19, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE EMBOLIZATION DEVICE FAILED TO OPEN. IT WAS REPORTED THAT THE PIPELINE WAS ADVANCED THROUGH THE CATHETER AND UNSHEATHED IN THE M1 ARTERY. THE DISTAL END TRUMPETED OPEN, FOLLOWED BY A STRAINED SEGMENT, THEN AN OPENED SEGMENT. THE DOCTOR RESHEATHED AND ATTEMPTED AGAIN, BUT THE PIPELINE LOOKED FRAYED AND TRUMPETED ON THE END. MORE THAN 50% FAILED TO OPEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND GOT STOCK IN THE HUB OF THE MICROCATHETER. A SECOND PIPELINE WAS USED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY SUPERIOR TO HYPOPHYSEAL. THE VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A PHENOM CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10174162 ↗
• MalfunctionJun 15, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE WOULD NOT OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT PARAOPTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 13MM AND A 5.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PROXIMAL SEGMENT OF THE PIPELINE OPENED AS EXPECTED, HOWEVER THE DISTAL SEGMENT UNDER THE PTFE SLEEVES WOULD NOT OPEN IN THE ARTERY. THE PIPELINE WAS RE-SHEATHED LESS THAN THREE TIMES, LESS THAN 50% OF THE DEVICE WAS DEPLOYED, AND THE MIDDLE SEGMENT OF THE DEVICE WAS IN BEND. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS WERE SATISFACTORY WITH ANOTHER THERAPY CHOSEN. ANCILLARY DEVICES INCLUDE A 6F SHUTTLE SHEATH, NAVIEN 072, AND PHENOM 27.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10155207 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT AFTER SUCCESSFUL DEPLOYMENT OF THE PIPELINE FLEX, DURING THE RETRIEVAL OF THE DELIVERY WIRE, WHILE PULLING THE WIRE BACK INTO THE PHENOM .027 MICRO CATHETER, JUST PROXIMAL TO THE RESHEATHING PAD THE WIRE BROKE. THE PHYSICIAN COULD TELL BY TACTILE FEEDBACK, IMMEDIATELY PULLED THE WIRE AND MICRO CATHETER INTO THE PHENOM PLUS AND THANKFULLY THE WIRE THAT BROKE OFF GOT LODGED INTO THE PHENOM PLUS AND WAS SUCCESSFULLY REMOVED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520219 ↗
• MalfunctionMar 11, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING A LEFT CAROTID CAVERNOUS ANEURYSM PIPELINE EMBOLIZATION, THE SECOND PIPELINE WAS DELIVERED WITHOUT ISSUES. HOWEVER, THE DEVICE WAS NOTED NOT TO HAVE OPEN AT THE DISTAL SECTION. THE DEVICE APPEARED FLARED AND DID OPEN IN THE MIDDLE. IT WAS DECIDED TO REMOVED THE PIPELINE AND ONLY TREAT THE PATIENT WITH ONE PREVIOUSLY IMPLANTED PIPELINE. THE ANATOMY WAS NOT TOO TORTUOUS. NO PATIENT INJURY OCCURRED AND THE DEVICES WERE DISCARDED AT THE SITE. BOTH PIPELINE DEVICES WERE DELIVERED THROUGH THE SAME PHENOM CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409403 ↗

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-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-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