PIPELINE PED-425-18 (UDI 00847536016170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536016170), received between May 22, 2020 and Jun 1, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE WITH THE PIPELINE AND THE PHENOM27. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT FOR FLOW DIVERSION OF AN UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 5MM NECK DIAMETER. THE LANDING ZONE DIAMETERS WERE 3.8MM ON THE DISTAL END AND 4.3MM ON THE PROXIMAL END. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6-7MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THERE WAS A SUSPECTED KINK OR OVALIZATION OF PHENOM 27 MICROCATHETER. PED WOULD NOT TRACK PAST CERTAIN MID-POINT OF THE MICROCATHETER. THE PIPELINE WAS STUCK IN THE MIDDLE SECTION, WHICH OCCURRED DURING DELIVERY. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE AND THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE ISSUE WAS NOT RESOLVED. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL) AND THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. DAPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569432 ↗
• MalfunctionJun 8, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DUE TO SEVERE TORTUOSITY, THE DEVICE DID NOT OPEN IN THE PROXIMAL CURVE OF THE ANEURYSM. IT WAS NOTED THE PROXIMAL PART OF THE STENT WAS POSITIONED IN A BEND, MORE THAN 50% OF THE STENT HAD BEEN DEPLOYED, RE-SHEATHING WAS DONE LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. THE MICROCATHETER AND PIPELINE WERE REMOVED TOGETHER, AND REPLACEMENT PRODUCTS WERE USED 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. POST-PROCEDURE ANGIOGRAPHIC RESULTS LOOKED GOOD WITH SECOND DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY SUP RACLINOID SEGMENT WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S  VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, BUT THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN. ANCILLARY DEVICES INCLUDE A NEURON MAX SHEATH, NAVIEN 5F GUIDE CATHETER, PHENOM 27 MICROCATHETER, AVIGO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957673 ↗
• MalfunctionMar 18, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT HAD RESISTANCE WITH A MARKSMAN MICROCATHETER DURING DELIVERY AND RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) CAVERNOUS SEGMENT. THE ANEURYSM MEASURED 4 X 3.6MM AND THE NECK DIAMETER WAS 3.1MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE DURING THE PROCEDURE. AS THE PHYSICIAN DEPLOYED THE PIPELINE, EXCESSIVE RESISTANCE WAS FELT AND THE DISTAL END OF THE PIPELINE WAS DEFORMED. THE PHYSICIAN ATTEMPTED TO RESHEATH THE PIPELINE AND DEPLOY AGAIN BUT THE DEVICE WAS STUCK IN THE DISTAL END OF THE CATHETER AND COULD NOT BE MOVED. THE PHYSICIAN ATTEMPT TO RELEASE THE SLACK IN THE SYSTEM BUT IT DID NOT RESOLVE THE ISSUE. THE ENTIRE SYSTEM WAS REMOVED. THE CATHETER WAS FOUND STRETCHED AT THE DISTAL END. NO DAMAGE OF THE PIPELINE PUSHWIRE WAS OBSERVED. BOTH THE MARKSMAN AND THE PIPELINE WERE REPLACED AND THE PROCEDURE WAS THEN COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515235 ↗
• MalfunctionMay 22, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DID NOT OPEN DURING THE PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM LOCATED IN PARAOPHTHALMIC SEGMENT. MEASURING 10MMX5MM, LANDING ZONE DISTAL 4.3MM PROXIMAL 4.1MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE REPORTED PIPELINE, THERE WAS A FLATTENING OF THE BRAID OBSERVED IN SEVERAL PLANES. MULTIPLE ATTEMPTS WERE MADE BY THE PHYSICIAN TO FACILITATE OPENING OF THE BRAID, DISTALLY ACROSS THE NECK OF THE ANEURYSM AND THROUGH THE ANTERIOR GENU ADEQUATE APPOSITION WAS OBSERVED ANGIOGRAPHICALLY. THE SEGMENT OF THE BRAID DIRECTLY DISTAL TO THE RESHEATHING PAD WAS CONTINUED TO BE OBSERVED AS FLATTENED IN 2+ PROJECTIONS. AFTER SEVERAL MORE ATTEMPTS TO ENCOURAGE THE PIPELINE TO OPEN, THE DECISION WAS MADE TO RELEASE THE DEVICE- BUT THE DEVICE REMAINED ENGAGED, AT WHICH POINT THE PHYSICIAN WAS ABLE TO FULLY RECAPTURE THE DEVICE AND COMPLETE THE PROCEDURE WITH ANOTHER DEVICE, WHICH THEN OPENED IN ALL ASPECTS BEING SUCCESSFULLY DEPLOYED TO THE PHYSICIANS JUDGMENT. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084089 ↗

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-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-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