PIPELINE PED-375-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536015692), received between Jun 6, 2019 and Jul 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FAILURE TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) POSTERIOR COMMUNICATING (PCOMM) SEGMENT. THE ANEURYSM MAX DIAMETER WAS 7.3MM AND THE NECK DIAMETER WAS 6.5MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS DELIVERED SMOOTHLY TO THE MIDDLE CEREBRAL ARTERY (MCA) M2. THE WHOLE SYSTEM WAS PULLED BACK TO THE M1 AND DEPLOYMENT WAS INITIATED. AFTER DEPLOYING 7-8MM OF THE STENT, THE TIP END DID NOT OPEN. THE PHYSICIAN CONTINUED DEPLOYMENT TO 11-12MM AND WAITED 10 SECONDS. THE MIDDLE AND PROXIMAL SEGMENT OF THE PIPELINE WERE ABLE TO OPEN BUT THE DISTAL END STILL FAILED TO OPEN AND HAD A FISH MOUTH SHAPE. THE DEVICE STILL FAILED TO OPEN WITH REPEATED ADJUSTMENTS. NO OTHER STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINE. THE DEVICE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN WAS OBSERVED. THE PIPELINE WAS RESHEATHED 2 OR LESS TIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224996 ↗
• MalfunctionJun 6, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MICROCATHETER WAS IN PLACE AND AFTER THE STENT WAS IN PLACE, THE STENT WAS RELEASED, AND THE TIP OF THE STENT COULD NOT BE OPENED. IT COULD NOT BE OPENED AFTER REPEATED ATTEMPTS. IT WAS NOTED THE DISTAL SECTION OF THE STENT DID NOT OPEN. THE STENT WAS NOT POSITIONED IN A BEND. IT WAS RE-SHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE STENT. THE STENT WAS REMOVED AND A NEW STENT WAS USED TO COMPLETE THE OPERATION. IT WAS NOTED IT WAS RE-SHEATHED AND REMOVED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED AT THE VERTEBRAL ARTERY WITH A MAX DIAMETER OF 6.2*5.6MM AND A NECK DIAMETER OF 9MM. THE DISTAL LANDING ZONE WAS 3.73MM AND THE PROXIMAL LANDING ZONE WAS 3.71. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SLOW BLOOD FLOW. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677292 ↗
• MalfunctionJun 6, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE PIPELINE COULD NOT BE OPENED, EVEN AFTER MULTIPLE ADJUSTMENTS. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 12MM AND A NECK DIAMETER OF 8MM. IT WAS NOTED THAT THE PATIENT HAD A MINIMAL VESSEL TORTUOSITY. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THE PIPELINES WERE NOT PLACED IN THE BEND. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED "PARTIAL REMAIN." THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8676940 ↗

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-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-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-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-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