PIPELINE PED-450-20 (UDI 00847536016477)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536016477), received between Apr 27, 2017 and Aug 6, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A MARKSMAN CATHETER THAT HAD RESISTANCE DURING DEPLOYMENT OF A PIPELINE DEVICE AND BOTH DEVICES WERE FOUND TO BE DAMAGED. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 9MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT AFTER THE MARKSMAN CATHETER WAS IN PLACE IN THE DISTAL MIDDLE CEREBRAL ARTERY, THE PIPELINE WAS ADVANCED TO THE DISTAL TIP OF THE CATHETER AND PREPARED TO DEPLOY. WHEN DEPLOYING THE PIPELINE, THE RESISTANCE AT THE DISTAL MARKSMAN CATHETER WAS SEVERE. IT WAS OBSERVED THAT THE DISTAL END OF THE PIPELINE OPENED VERY LARGE. THE DEVICES WERE WITHDRAWN TOGETHER FROM THE PATIENT'S BODY AND IT WAS FOUND THAT THE DISTAL TIP OF THE PIPELINE WAS STRETCHED AND DAMAGED AND THE DISTAL TIP OF THE MARKSMAN CATHETER WAS ALSO DEFORMED. ALL DEVICES HAD BEEN PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED A CONTINUOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291540 ↗
• MalfunctionJul 22, 2021Break; Unintended Ejection; Physical Resistance/Sticking; Break; Unintended Ejection; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE PHENOM 27 MICROCATHETER AND WAS FOUND TO BE OPENED PREMATURELY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4MM DISTAL AND 4.46MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. IT WAS REPORTED THAT WHEN THE PIPELINE WAS PUSHED INTO THE PHENOM 27 IT ENCOUNTERED RESISTANCE IN THE DISTAL SEGMENT. WHEN THE PIPELINE WAS WITHDRAWN, THE PIPELINE WAS UNLOADED FROM THE PUSH GUIDE WIRE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS, AND ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE GOOD. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214925 ↗
• MalfunctionMay 24, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE PIPELINE WAS "NESTING INSIDE ANOTHER" PIPELINE. ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS DEFORMED AND REMOVED FROM THE PATIENT'S BODY AND ANOTHER PIPELINE WAS USED.  THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF A C7 SEGMENT. THE ANEURYSM MAX DIAMETER WAS 10MM AND THE NECK DIAMETER WAS 8MM. VESSEL TORTUOSITY WAS NORMAL. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY SHOWED NORMAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871418 ↗
• MalfunctionDec 9, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS LARGE RESISTANCE WITH THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976573 ↗
• MalfunctionDec 8, 2020Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THERE WAS NO DAMAGE TO THE DEVICE OR MICROCATHETER UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972767 ↗
• MalfunctionSep 8, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN, AND THE MARKSMAN WAS KINKED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 3.42MM AND A 2.30MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND THE PRU LEVEL WAS 40. IT WAS REPORTED THAT THE TIP OF THE PIPELINE WAS DEPLOYED, ANCHORED, AND THEN DEPLOYED. THE STENT WAS KINKED WHEN PASSING THROUGH A CURVED BLOOD VESSEL, AND IT COULDN'T BE DEPLOYED AFTER REPEATED PUSHING AND PULLING. AFTER TWO ATTEMPTS, THE STENT STILL COULDN'T BE OPENED, AND THE STENT HAD A CERTAIN DISPLACEMENT. AS A RESULT, THE WHOLE SYSTEM WAS WITHDRAWN FROM THE PATIENT. AFTER WITHDRAWN, IT WAS FOUND THAT THE DISTAL SOFT SECTION OF THE MARKSMAN MICROCATHETER WAS KINKED, AND THE PIPELINE TIP HAD BURRS. A NEW PHENOM MICROCATHETER AND STENT WERE THEN USED TO SUCCESSFULLY COMPLETE THE SURGERY. 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 ANGIOGRAP

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10505082 ↗
• MalfunctionJul 23, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE STENT THAT DID NOT OPEN DURING A PROCEDURE WITH A AND WAS OBSERVED TO BE DAMAGED UPON REMOVAL. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF AN OPHTHALMIC ARTERY SEGMENT. THE ARTERY MAX DIAMETER WAS 9.65MM AND THE NECK DIAMETER WAS 6.33MM VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL THE DEVICES USED IN THE PROCEDURE WERE PREPARED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE DID NOT OPEN COMPLETELY AT THE DISTAL END DURING THE PROCEDURE SO THE CATHETER AND PIPELINE DEVICE WERE WITHDRAWN FORM THE PATIENT'S BODY TOGETHER. IT WAS THEN DISCOVERED THAT THE PIPELINE WAS OVERLAPPED. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT AND POST-PROCEDURE ANGIO WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10314697 ↗
• MalfunctionSep 18, 2019Break; Unintended Movement; Break; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED AMORPHOUS RIGHT SUPRACLINOID ANEURYSM. MEASURING 15MMX6MMM, LANDING ZONE DISTAL 3.50MM PROXIMAL 4.25MM. THE VESSEL WAS OBSERVED MINIMAL TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT PIPELINE DEVICE HAD BEEN PARTIALLY DELIVERED, RESHEATHED, THEN REMOVED FROM THE PATIENT DUE TO A LOSS OF ACCESS. THE SYSTEM WAS REMOVED FROM THE PATIENT. ON THE BACK TABLE, WHILE PULLING THE PIPELINE OUT OF THE CATHETER, THE LEAD WIRE OF THE PIPELINE DELIVERY WIRE BROKE OFF. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9084672 ↗
• MalfunctionJun 13, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLOW DIVERTERS FAILED TO EXPAND IN THE MIDDLE SEGMENT. THIS EVENT WAS REPORTED HAVE OCCURRED DURING THE TREATMENT OF INTERNAL CAROTID ARTERY, UNRUPTURED ANEURYSM. THE ANATOMY WAS REPORTED TO HAVE BEEN SEVERE IN VESSEL TORTUOSITY. THE MIDDLE SEGMENT OF THE DEVICE WAS PLACED ON A BEND. BOTH DEVICES WERE DEPLOYED MORE THAN 50% WHEN IT FAILED TO OPEN. THE DEVICES WERE RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICES AND EACH ONE WAS REMOVED WITH THE CATHETER. A NEW DEVICE WAS SUCCESSFULLY USED TO TREAT THE PATIENT. NO PATIENT INJURY REPORTED. THE DEVICES WERE PREPARED AND USED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696510 ↗
• MalfunctionMay 5, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT RESISTANCE FELT DURING DELIVERED PIPELINE FLEX IN THE MARKSMAN CATHETER AND AFTER THAT DISTAL END OF THE PIPELINE DID NOT OPEN. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A ANEURYSM WITH FLOW DIVERSION. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE OPERATION, MICROCATHETER WAS FOUND TO HAVE GREAT RESISTANCE DURING THE DELIVERY OF THE STENT, AND BARELY COMPLETED THE RELEASE OF PIPELINE FLEX. IT WAS REPORTED THAT THE PROXIMAL END OF THE PIPELINE FLEX STENT WAS NOT FULLY OPENED AND NOT ATTACHED TO THE WALL. A BALLOON WAS USED TO EXPAND THE PIPELINE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8580857 ↗
• MalfunctionNov 19, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE PIPELINE EMBOLIZATION, THE DISTAL TIP 2-3 MM OF THE PIPELINE DEVICE APPEARED DENSER UNDER RADIO OPAQUE IMAGES AND THE DISTAL TIP WOULD NOT OPEN. MORE THAN 50 % OF THE DEVICE WAS DEPLOYED WHEN THIS EVENT WAS NOTED. THE DEVICE WAS RE-SHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THE DEVICE WAS RE-SHEATHED AND REMOVED WITH THE CATHETER. THE ANATOMY WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ANEURYSM WAS IN THE LEFT INTERNAL CAROTID ARTERY, PCOM. IT WAS UNRUPTURED, FUSIFORM WITH A MAX DIAMETER OF 5MM AND A NECK OF 4MM. THE LANDING ZONE WAS 4.5 DISTALLY AND PROXIMALLY IT WAS 4MM. YES, THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085346 ↗
• MalfunctionJul 18, 2018Difficult to Open or Close; Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE HEAD OF THE PIPELINE WOULDN'T OPEN. THREE ATTEMPTS WERE THEN MADE TO RETURN THE PIPELINE TO THE MICROCATHETER AND OPEN THE DEVICE AGAIN BUT THE HEAD WOULDN'T OPEN. AS A RESULT THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME MODEL WHICH OPENED FREELY ALLOWING THE OPERATION TO BE COMPLETE SUCCESSFULLY. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 7.6MM AND A NECK DIAMETER OF 5.3MM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE. IT WAS CONFIRMED THAT DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AND THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED PER THE IFU. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THAT THE BLOOD FLOW HAD SLOWED DOWN. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7698127 ↗
• MalfunctionApr 27, 2017Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY, THE PIPELINE DEVICE DID NOT OPEN DISTALLY. THE PIPELINE WAS REMOVED AND A NEW PIPELINE OF THE SAME SIZE WAS DEPLOYED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED. THE ANEURYSM WAS IRREGULAR IN SHAPE, MAX DIAMETER WAS 4.77 MM X 3.7 MM. THE NECK WIDTH WAS 2.8 MM. THE PROXIMAL LANDING ZONE WAS 4 MM AND THE DISTAL WAS 4.45 MM. THE PATIENT HAD MODERATE VESSEL TORTUOSITY AND THE PIPELINE WAS DEPLOYED ON A CURVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6527123 ↗

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