PIPELINE PED-475-16 (UDI 00847536016682)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536016682), received between Mar 15, 2019 and Mar 2, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE INITIAL REPORTED PIPELINE INFORMATION WAS INCORRECT AND THE COMPLAINT PIPELINE WAS MODEL#: PED-475-18, LOT#: B136580.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402126 ↗
• MalfunctionMar 9, 2020Retraction Problem; Material Deformation; Activation Failure; Retraction Problem; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FAILED TO DEPLOY AND TWO DELIVERY SYSTEMS BECAME STUCK UPON REMOVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LEFT, SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST PIPELINE (PLI40) WAS DELIVERED TO THE DISTAL ICA TERMINUS. THE WIRE WAS RETRIEVED, AND UPON PULLING OUT THE WIRE, IT BECAME STUCK IN THE MIDDLE SEGMENT OF THE PHENOM 27 MICROCATHETER. EVERYTHING WAS REMOVED, A SECOND PHENOM 27 WAS DELIVERED FOLLOWED BY A SECOND PIPELINE (PLI30). THE PIPELINE BECAME TWISTED AND WOULD NOT STRAIGHTEN OUT OR OPEN AFTER NUMEROUS RE-SHEATHING AND RE-DEPLOYMENT ATTEMPTS. UPON REMOVAL, THE PIPELINE BECAME STUCK ABOUT HALFWAY, AND THE ENTIRE SYSTEM WAS REMOVED. A THIRD PHENOM 27 WAS USED AND SUCCESSFULLY DELIVERED THE SECOND PIPELINE INTO THE PATIENT SUCCESSFULLY TO COMPLETE THE PROCEDURE. 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. ANCILLARY DEVICES INCLUDE A NEURON MAX AND NAVIEN 58.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9804188 ↗
• MalfunctionDec 23, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLEX DEVICE FAILED TO OPEN. THE LEFT ICA WAS TORTUOUS LEADING UP TO THE ANEURYSM- THE ANEURYSM BEING LOCATED JUST DISTAL TO THE ANTERIOR GENU AND THE ORIGIN OF THE OPHTHALMIC ARTERY. THERE WAS DIFFICULTY GETTING ANY WIRE TO PASS THE PCOM BRANCH TO GET TO THE MCA TO ALLOW THE PHENOM 27 TO TRACK. AFTER SUCCESSFULLY GETTING THE WIRE (TRANSCEND) TO THE M1, THE CASE PROCEEDED. A TOTAL OF 3 PIPELINE DEVICES WERE USED- ONLY THE FINAL DEVICE WAS DEPLOYED. THE FIRST DEVICE OPENED WAS A 4.75X16 CONSIGNED PRODUCT LOT A835655, WHICH DID NOT OPEN WHEN PLACED IN THE M1. ONLY VERY DISTAL OPENING WAS OBSERVED, AND THE DEVICE WAS PULLED BACK TO A LARGER DIAMETER VESSEL AND MORE OF THE DEVICE RELEASED TO SEE IF IT WOULD OPEN. THE PTFE SLEEVES WERE "BUMPED" BACK WITHOUT SUCCESSFUL DEVICE OPENING. MORE SUPPORT WAS GARNERED FROM THE NAVIEN AND PHENOM- LOADING THE ENTIRE SYSTEM WITHOUT SUCCESSFUL OPENING OF THE DEVICE. THIS DEVICE WAS THEN REMOVED AND A 4.75X14 (TRUNK STOCK) DEVICE WAS OPENED LOT A873205. THIS DEVICE BEHAVED IN A SIMILAR FASHION- WITH A RIBBON SHAPED APPEARANCE ANGIOGRAPHICALLY. AFTER MUCH MANIPULATION OF THE DEVICE IT BECAME CLEAR THAT IT WOULD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511150 ↗
• MalfunctionMar 15, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL SECTION OF THE PIPELINE HAD POOR DEPLOYMENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RESHEATHED 2 TIMES. A CONTINUOUS FLUSH WAS USED. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE SPECIFIC OCCURRENCE LOCATION OF ANEURYSM: INTERNAL CAROTID ARTERY - CAVERNOUS SINUS (IC - CAVERNOUS). THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE VESSEL DIAMETER OF LANDING ZONE: (DISTAL SIDE) 3.5MM, (PROXIMAL SIDE) 4.5MM. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8425639 ↗

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-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-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