PIPELINE PED-500-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536016897), received between Jun 24, 2019 and May 5, 2021 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TWO PIPELINE DEVICES FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE PARAOPHTHALMIC SECTION OF THE RIGHT ICA. THE MAX DIAMETER WAS 4.18MM, AND THE NECK DIAMETER WAS 4.28MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE WAS 4.18MM DISTAL AND 4.87MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 60. IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO DEPLOY THE (B)(4) AS PER THE INSTRUCTIONS FOR USE (IFU), BUT IT DID NOT OPEN. THE DISTAL PORTION SLIGHTLY OPENED BUT WAS SEVERELY FLAT AROUND THE GENU. THE PHYSICIAN ATTEMPTED TO RESHEATH AND CENTER THE DEVICE, AND HAD THE NAVIEN CATHETER IN THE VERTICAL PETROUS SEGMENT. AFTER SEVERAL ATTEMPTS, THE DOCTOR PULLED OUT THE DEVICE ALONG WITH THE  MARKSMAN CATHETER. THE DOCTOR REPLACED THE MARKSMAN AND DOWNSIZED THE PIPELINE TO A (B)(4). THEY ATTEMPTED TO OPEN IN THE MIDDLE CEREBRAL ARTERY SEGMENT (MCA), BUT THE PIPELINE DID NOT OPEN DISTALLY OR "CIGARED" WHERE THE MIDDLE PORTION WOULD OPEN. THE PHYSICIAN PUSHED THE WIRE MORE THAN 50% WITH BOTH DEVICES WHEN THEY FAILED TO OPEN. AFTER NOTICING SPASM IN THE MCA S

  Patient problems: Vasoconstriction

  MAUDE report 11780524 ↗
• MalfunctionDec 11, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT WHILE ATTEMPTING TO OPEN THE DEVICE, IT WOULD NOT OPEN CORRECTLY IN THE DISTAL SECTION OF THE PIPELINE. IT WAS STATED IT LOOKED LIKE A TULIP. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED. IT WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS POSITIONED IN A DISTAL PART OF A BEND. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE OPTHALMIC ARTERY WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 4MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS SEVERE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10993291 ↗
• MalfunctionOct 26, 2020Break; Activation Failure; Physical Resistance/Sticking; Break; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE 5.0X12 PIPELINE DEVICE WAS INTRODUCED TO THE VESSEL DISTAL TO THE ANEURYSM. HOWEVER, THE DISTAL PORTION OF THE STENT WOULD NOT OPEN AFTER SEVERAL ATTEMPTS. THE STENT WAS REMOVED, AND DURING RETRIEVAL, THE DELIVERY PUSHWIRE SEPARATED FROM THE IMPLANT NEAR THE HUB OF THE PHENOM 27 MICROCATHETER. THE STENT WAS REMOVED ALONG WITH THE CATHETER, AND REPLACEMENT PRODUCTS WERE USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THE PHYSICIAN USED SIGNIFICANT FORCE TO REMOVE THE PIPELINE DUE TO RESISTANCE IN THE HUB OF THE CATHETER, AND WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE CATHETER. 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 ANGIOGRAPHY SHOWED AN IMPLANTED PIPELINE WITH GOOD APPOSITION AND COVERAGE OF THE NECK OF THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT CAVERNOUS SEGMENT OF THE INTERNAL CA ROTID ARTERY WITH A MAX DIAMETER OF 12 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10733736 ↗
• MalfunctionSep 20, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE FAILED TO OPEN. IT WAS NOTED THE DISTAL SEGMENT OF THE STENT WAS POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS DONE LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REMOVED FROM THE PATIENT, AND A REPLACEMENT STENT WAS 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 ANGIOGRAPHY SHOWED INSIGNIFICANT RESULTS AND NORMAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT TRANSITIONAL REGION WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS IN RANGE. ANCILLARY DEVICES INCLUDE A SOFIA 056, PHENOM 027.

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

  MAUDE report 10558193 ↗
• MalfunctionJul 15, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE SEGMENT OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 30MM AND A 10MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING DEPLOYMENT, THE MIDDLE PORTION OF THE PIPELINE WOULD NOT OPEN DESPITE THE PHYSICIAN TRYING TO WAG THE SYSTEM AND COAX THE DEVICE OPEN. THE MIDDLE SEGMENT OF THE PIPELINE WAS POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS DONE LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE DONE TO OPEN THE DEVICE. THE PIPELINE WAS REMOVED FROM THE PATIENT, AND NOTABLE TRUMPETING OF THE DEVICE WAS OBSERVED. THE MICROCATHETER WAS LEFT IN PLACE, AND A REPLACEMENT DEVICE WAS 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 SHOWED NORMAL SLOWING OF THE FLOW INTO THE ANEURYSM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10281142 ↗
• MalfunctionMar 4, 2020Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN PROXIMALLY, AND BECAME HUNG UP WITH THE PHENOM 27 MICROCATHETER RESULTING IN A LOSS OF VESSEL ACCESS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 23 MM AND A 10 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST PIPELINE AND COILING WERE DEPLOYED WITH NO ISSUES. WHEN THE SECOND PIPELINE WAS DEPLOYED, IT DID NOT OPEN PROXIMALLY. DURING RECAPTURING OF THE TIP COIL, THE PROXIMAL BRAID MAY HAVE BEEN BUMPED WITH THE PHENOM 27 MICROCATHETER, BECAUSE THE PIPELINE BECAME HUNG UP AND SIMULTANEOUSLY PULLED THE WIRE, CAUSING THE PHYSICIAN TO LOSE ACCESS. THE HEALTHCARE PROVIDER (HCP) EXAMINED COMING FROM THE LEFT SIDE, BUT THE PATIENT DID NOT HAVE AN ANTERIOR COMMUNICATING (ACOM) ARTERY, AND SO THE HCP HAD TO SACRIFICE THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT DID WAKE UP OKAY FROM THE PROCEDURE. IT WAS NOTED MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, IT WAS "RESHEATHED" LESS THAN OR EQUAL TO TWO TIMES, A WIRE/CATHETER WAS USED TO TRY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9785613 ↗
• MalfunctionJan 7, 2020Break; Activation Failure; Physical Resistance/Sticking; Break; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX FAILED TO OPEN AT THE DISTAL END AND THE TIP SEPARATED WITHIN THE CATHETER. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TRYING TO GET THE DISTAL END OF THE PIPELINE TO OPEN. STANDARD TROUBLESHOOTING TECHNIQUES WERE TRIED WITH A LOT OF CATHETER AND DISTAL PIPELINE MANIPULATION IN THE VESSEL. ALTHOUGH THE DISTAL END OF THE PIPELINE WOULD NOT OPEN, THE MID-SECTION DID OPEN SOME. THERE WAS SIGNIFICANT TENSION AND RESISTANCE FELT WHILE ATTEMPTING TO RETRACT AND REMOVE THE UN-DEPLOYED PIPELINE DEVICE AND PUSHWIRE BACK INTO THE PHENOM 27. ONCE THE CATHETER WAS FULLY REMOVED FROM THE PATIENT, THE PIPELINE WAS CONFIRMED TO BE STUCK INSIDE OF THE MICRO-CATHETER WHICH WAS RETRIEVED OUT BY THE PHYSICIAN AND THE TIP WAS DETACHED. THE PED WAS STUCK (LOCKED UP) IN CATHETER. THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. A CONTINUOUS FLUSH WAS USED. THE CATHETER WAS KINKED AND FLATTENED IN THE DISTAL SECTION. THE PIPELINE PUSHWIRE BROKE AT THE DISTAL END. THE PIPELINE¿S DISTAL SECTION WAS PLACED IN A BEND IN THE ANATOMY. LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN THE DEVICE FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES. NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558489 ↗
• InjuryNov 1, 2019Break; Detachment of Device or Device Component; Activation Failure; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX PUSHWIRE SEPARATION DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA.) ANATOMY WAS REPORTEDLY VERY TORTUOUS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT DURING THE PROCEDURE, A PIPELINE FLEX WAS ATTEMPTED TO BE PLACED. THE DISTAL SECTION OF THE PIPELINE WAS UNSHEATHED, THEN DRAGGED BACK INTO POSITION. THE DISTAL END OF THE PIPELINE REPORTEDLY DID NOT FULLY OPEN AS THE LANDING ZONE WAS REACHED. DEPLOYMENT OF THE DEVICE WAS CONTINUED REGARDLESS. THE SYSTEM WAS WAGGED PUTTING FORWARD LOAD ON THE DEVICE ATTEMPTING TO OPEN IT. RESHEATHING WAS THEN ATTEMPTED, HOWEVER, IT WAS NOT POSSIBLE TO ADVANCE THE CATHETER OVER THE DEVICE. IT WAS THEN ATTEMPTED TO LOCK THE SYSTEM DOWN AND REMOVE IT AS ONE UNIT. WHILED PULLING BACK ON THE PIPELINE PUSHWIRE, IT BROKE LEAVING THE PIPELINE FLEX BRAID AND DISTAL PUSHER WIRE IN THE PATIENT. AFTER ATTEMPTING TO SNARE BOTH THE BRAID AND WIRE, THE BRAID FULLY OPENED AND APPOSED THE VESSEL WALL. HOWEVER, THE PIPELINE WAS NOT PLACED IN THE INTENDED LOCATION. THE SEPARATED PUSHWIRE SECTION WAS EVENTUA

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

  MAUDE report 9268951 ↗
• MalfunctionJun 24, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL END DURING THE PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN PERI CLINOID, MEASURING 4MMX3MM, LANDING ZONE DISTAL 4.3MM PROXIMAL 5MM IT WAS REPORTED THAT WHILE TRYING TO DEPLOY THE PIPELINE THE DISTAL END WAS NOT OPENING. THE PHYSICIAN RESHEATHED 2 TIMES AND DID NOT LIKE THE WAY THE DEVICE WAS OPENING SO HE REMOVED THE DEVICE AND CATHETER. UPON REMOVAL IT WAS NOTED THE DISTAL END WAS NOT FULLY OPENED. THE PIPELINE RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE PRU LEVEL WAS 140. NO IMAGES AVAILABLE FOR REVIEW. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. LESS THAN 50% PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. LESS THAN OR EQUAL TO 2 TIMES THE PIPELINE WAS RESHEATHED. THE ANGIOGRAPHIC RESULT WAS GOOD POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729498 ↗

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-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-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-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