PIPELINE PED-425-16 (UDI 00847536016149)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536016149), received between Dec 4, 2018 and Jul 11, 2022 — classified as 2 injuries, 9 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 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 3.61MM, AND THE NECK DIAMETER WAS 2.39MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.44MM DISTAL AND 3.98MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS NOT ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE WAS DELIVERED TO THE INTENDED LOCATED AND THE CATHETER WAS WITHDRAWN. THE TIP OF THE STENT WAS OUT OF THE MICROCATHETER, BUT THE BLADE OF THE PROTECTIVE SLEEVE WAS NOT DETACHED FROM THE TIP OF THE PIPELINE. THE PIPELINE COULD NOT BE FULLY OPENED, AND AFTER ADJUSTMENT THE EFFECT WAS NOT IDEAL SO THE PIPELINE WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978298 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT HAD A PROCEDURE ON (B)(6) 2021 AND ON (B)(6) 2021 SHE COLLAPSED, BECAME UNCONSCIOUS, WAS TAKEN TO THE HOSPITAL WERE THEY DIAGNOSED HER WITH ENHANCING BRAIN LESIONS/MASSES WITH VASOGENIC EDEMA. CT CAP WAS FOUND TO BE NEGATIVE FOR MALIGNANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema; Syncope/Fainting

  MAUDE report 13232954 ↗
• MalfunctionDec 19, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE TIP COULD NOT BE OPENED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THE ANGIOGRAPHIC RESULTS POST PROCEDURE WERE NORMAL. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT WAS NOT APPROVED. THE PIPELINE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE C6 WITH A MAX DIAMETER OF 8MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040621 ↗
• MalfunctionJun 7, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD BEEN PLACED IN A STRAIGHT SECTION AND NOT A BEND WHEN IT FAILED TO OPEN. IT HAD BEEN RESHEATHED ONCE. NORMAL DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946645 ↗
• MalfunctionJul 31, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX STUCK (LOCKED UP) IN CATHETER OR RESISTANCE IN MEDTRONIC CATHETER. IT WAS REPORTED THAT HEAVY RESISTANCE IN INSERTIONS OF PIPELINE INTO THE CATHETER IMMEDIATELY FELT HEAVY RESISTANCE. THE CATHETER FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. REMOVED AND REPLACED THE BOTH DEVICES. ONCE DEVICES REPLACED NEW PIPELINE AND MEDTROINC WORKED WITHOUT ISSUE. THE PATIENT WAS BEING TREATED FOR A 5MM ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. THE VESSEL TORTUOSITY WAS MODERATE, THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS, OR INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PIPELINE FLEX DEVICE PUSHWIRE FOUND BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10350834 ↗
• MalfunctionMay 22, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE DEVICE THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT DISTAL INTERIOR CAROTID ARTERY. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE PROCEDURE THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES BUT STILL FAILED TO OPEN THOUGH NO OTHER ADDITIONAL STEPS WERE TAKE TO TRY AND OPEN THE PIPELINE. THE PIPELINE HAD BEEN PREPARED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE. IT WAS NOT POSITIONED IN A BEND DURING THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER PIPELINE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10083532 ↗
• MalfunctionFeb 12, 2020Break; Unintended Ejection; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Unintended Ejection; Detachment of Device or Device Component; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700354 ↗
• MalfunctionDec 13, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ICA ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED AND THEN REMOVED BECAUSE IT WASN'T OPENING AT THE DISTAL SEGMENT. A NEW PIPELINE WAS CHOSEN AND SUCCESSFULLY IMPLANTED. THE PIPELINE WAS NOT POSITIONED IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. IT WAS RESHEATHED AND REMOVED FROM THE MICROCATHETER AND PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9466364 ↗
• MalfunctionNov 13, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT REPORTED PIPELINE FLEX PUSHWIRE BROKE DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED AMORPHOUS RIGHT OPHTHALMIC ARTERY ANEURYSM. MEASURING 3MMX6MM, LANDING ZONE DISTAL 3.3MM PROXIMAL 3.9MM. THE VESSEL WAS OBSERVED MINIMAL TORTUOUS. IT WAS REPORTED THAT THE PIPELINE WAS 40% DEPLOYED, IT WAS FULLY OPEN DISTAL. WHEN STOPPED TO TAKE A ANGIO AND WHEN THE PHYSICIAN WENT TO CAPTURE THE DEVICE TO MOVE IT DOWN ABOUT A MM HE FELT A POP. THAT¿S WHEN THE PUSHER CAME DETACHED FROM THE PIPELINE WIRE. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY WAS REPORTED. THE PARTIALLY DEPLOYED PIPELINE WAS CAPTURED BY RUNNING UP THE MEDTRONIC GUIDECATHETER OVER IT AND REMOVING THE ENTIRE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316379 ↗
• InjurySep 3, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT AFTER THE PIPELINE FLEX WAS DEPLOYED, THE TIP WIRE BROKE OFF WHEN ATTEMPTED TO RETRIEVE INTO THE PHENOM 27. THE TIP REMAINS WITHIN THE PATIENT. THE ANEURYSM WAS SUCCESSFULLY TREATED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. THE ANEURYSM WAS IN THE SUPRA CLINOID INTERNAL CAROTID. THE ANEURYSM WAS UNRUPTURED. THE MORPHOLOGY WAS SACCULAR. THE MAX DIAMETER WAS 6MM AND THE NECK WAS 4MM. THE DISTAL AND PROXIMAL LANDING ZONE WAS 4MM.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8957099 ↗
• MalfunctionDec 4, 2018Migration; Migration

  MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT, THE PIPELINE FLEX (PED) DEVICE MIGRATED PROXIMAL AFTER PLACEMENT. THE PATIENT WAS UNDERGOING FLOW DIVERSION OF A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT INTERNAL CAROTID ARTERY, MEASURING 7MMX5MM, LANDING ZONE DISTAL 3MM, PROXIMAL 4MM. THE VESSEL WAS OBSERVED AS SEVERELY TORTUOUS. IT WAS REPORTED THAT PED WAS DELIVERED WITHOUT INCIDENT. THE PROXIMAL END WAS LAZY OPEN; HOWEVER, IT OPENED ONCE FULLY DEPLOYED. A NON-MEDTRONIC GUIDEWIRE WAS USED TO SMOOTH EXPAND THE PED AT THE PROXIMAL END. THE PED LOOKED FULLY OPENED AND APPOSED. WHEN THE DISTAL END WAS RELEASED, THE DEVICE WAS ALLEGED TO HAVE MIGRATED PROXIMALLY. THE PED IS NOW PARTIALLY CROSSING THE NECK BUT NOT FULLY COVERING THE NECK OF THE ANEURYSM. MULTIPLE TIMES WERE MADE TO CROSS THE PED WITH THE IDEA TO DELIVERY ANOTHER PED DISTAL TO THE FIRST. HOWEVER, THE WIRE WAS UNABLE TO NAVIGATE DISTALLY. THE PATIENT WILL BE RETREATED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AND NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS DUAL ANTIPLATELET TREATMENT. THE PRU LEVEL WAS 130.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129156 ↗

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-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-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