PIPELINE PED-475-25 (UDI 00847536016774)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536016774), received between Jul 6, 2018 and Oct 18, 2021 — classified as 1 death, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE PIPELINE WAS DEPLOYED DURING THE OPERATION, IT WAS FOUND THAT IT STUCK AT THE CATHETER HUB AND COULD NOT BE PUSHED OUT. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. THERE WAS NO CATHETER OR PUSHWIRE DAMAGE. THE PATIENT WAS UNDERGOING SURGERY TO TREAT UNRUPTURED, AMORPHOUS ANEURYSMS OF THE RIGHT MIDDLE CEREBRAL AND INTERNAL CAROTID SEGMENTS OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 10MM AND A NECK DIAMETER OF 5MM. THE DISTAL LANDING ZONE WAS 2.5MM, AND THE PROXIMAL LANDING ZONE WAS 4.6. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, AND ITS DIAMETER WAS 3MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. 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 12652815 ↗
• MalfunctionMay 28, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT CAVERNOUS SINUS ARTERY. THE MAX DIAMETER WAS 13MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.1MM DISTAL AND 4.75MM PROXIMAL. IT WAS REPORTED THAT WHEN THE CATHETER WAS WITHDRAWN, IT WAS FOUND THAT THE TIP OF THE PIPELINE COULD NOT BE OPENED. THE TIP STILL COULD NOT BE OPENED UNDER NORMAL DEPLOYMENT OPERATION. THE BLOOD FLOW GUIDE EMBOLIZATION DEVICE WAS PULLED TO THE ORIGINAL POSITION IN THE INTERNAL CAROTID ARTERY TO DEPLOY, BUT THE TIP STILL COULDN'T BE OPENED. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED TWO OR LESS TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED TO TRY TO OPEN THE DEVICE. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE GOOD. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MARKSMAN CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901383 ↗
• MalfunctionMar 26, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT IN THE PROCESS OF USING THE PIPELINE EMBOLIZATION DEVICE (PED), THE TIP OPENED WELL, BUT THE MIDDLE SECTION WAS KINKED. AFTER REPEATED OPERATIONS, THE SURGEON STILL COULD NOT OPENED THE STENT. THE PED WAS NOT POSITIONED IN A BEND WHEN IT FAILED TO OPEN, MORE THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS PERFORMED LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED IN AN ATTEMPT TO OPEN THE STENT. THE DEVICE WAS WITHDRAWN FROM THE BODY, AND IT WAS FOUND THE STENT WAS STILL IN A KINKED STATE AND COULD NOT BE OPENED. THE MARKSMAN MICROCATHETER ALSO HAD A CERTAIN ACCORDION DAMAGE IN THE DISTAL SEGMENT. REPLACEMENT DEVICES 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 WERE NORMAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 3.2 MM AND A 2.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574545 ↗
• MalfunctionNov 20, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10877649 ↗
• MalfunctionNov 20, 2020Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10875364 ↗
• DeathFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR A LEFT-SIDED PIPELINE STENT. EIGHT DAYS LATER, THE PATIENT COLLAPSED AT HOME AND WAS FOUND TO HAVE A RUPTURE OF THE LEFT ANEURYSM. THE FOLLOWING DAY, THE PATIENT PASSED AWAY. IT WAS STATED THE DEVICE MALFUNCTIONED AND WAS CLARIFIED TO MEAN THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LARGE, LEFT OA ANEURYSM.

  Patient problems: Death; Rupture

  MAUDE report 9678490 ↗
• MalfunctionDec 17, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN AND THE BRAIDED TIP WAS ENTANGLED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, LEFT CAROTID CAVERNOUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5.1MM AND A 4.97MM NECK DIAMETER, AND A LANDING ZONE OF 3.07X4.77MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DISTAL TIP OF THE STENT COULD NOT BE OPENED AFTER TRYING MANY METHODS. MORE THAN 50% WAS DEPLOYED, IT WAS RESHEATHED MORE THAN TWO TIMES, A WIRE/CATHETER WAS USED, IT WAS NOT IN A BEND, BUT EVENTUALLY, THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT. OUTSIDE OF THE BODY, IT COULD BE SEEN THAT THE BRAIDED WIRE AT THE TIP END WAS ENTANGLED, AND IT COULD NOT BE OPENED NORMALLY BY USING A MARKSMAN IN VITRO. A NEW STENT WAS USED AND THE SURGERY WAS COMPLETED. 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. ANCILLARY DEVICES INCLUDE A NAVIEN AND MARKSMAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9484648 ↗
• MalfunctionSep 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT AFTER THE PIPELINE FLEX FAILED TO OPEN AT THE DISTAL SECTION. THIS EVENT OCCURRED DURING THE TREATMENT OF A RUPTURED, FUSIFORM, LEFT, BLISTERING, INTERNAL CAROTID ARTERY, ANEURYSM. THE MAX DIAMETER WAS 3.2MM, NECK WIDTH WAS 3MM. THE DISTAL LANDING ZONE WAS 2.4MM AND THE PROXIMAL WAS 4.6MM CAVERNOUS. THE VESSEL ANATOMY WAS MODERATE. LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN THE DEVICE STOPPED OPENING. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THE DEVICE WAS RESHEATHED AND REMOVED WITH THE CATHETER. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A NEW DEVICE WAS USED TO TREAT THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967103 ↗
• MalfunctionApr 12, 2019Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT AFTER PLACING THE PIPELINE FLEX, THE DISTAL TIP HAD DIFFICULTY EXPANDING AND THE DEVICE WAS UNABLE TO BE RESHEATHED. THE PIPELINE WAS IMPLANTED IN THE PATIENT. IT WAS PLACED IN A BEND. NO PATIENT INJURY OCCURRED. THE ANATOMY WAS MODERATE IN TORTUOSITY. THE VESSEL DIAMETER WAS REPORTED TO BE MEDIUM IN DIAMETER. THE ANEURYSM WAS UNRUPTURED. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8508698 ↗
• MalfunctionOct 23, 2018Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING EMBOLIZATION TREATMENT OF A MEDIUM SACCULAR CEREBRAL ANEURYSM LOCATED IN INTERNAL CAROTID CAVERNOUS SEGMENT, PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. IT WAS REPORTED THAT PIPELINE FLEX DEVICE WAS OPENED, AND PREPARATION WAS PERFORMED ACCORDING TO THE INSTRUCTION. THE PED WAS TRIED TO BE DEPLOYED BY REMOVING THE PROTECTION SLEEVE, HOWEVER, THE DISTAL SEGMENT OF THE PED DID NOT OPEN. ALTHOUGH THE PED WAS DEPLOYED AND RESHEATHED MANY TIMES, BUT STILL THE PIPELINE DID NOT OPEN. THE PIPELINE WAS REMOVED AND ANOTHER PIPELINE FROM DIFFERENT LOT NUMBER USED AND PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THE VESSEL WAS SEVERELY TORTUOUS AND SLIGHTLY LARGER MM IN DIAMETER. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994950 ↗
• MalfunctionOct 16, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE MEDTRONIC FLOW DIVERSION DEVICE COULD NOT BE OPENED AT A CERTAIN PLACE AND WAS ¿COMMENTED¿ AS BEING HARD DURING DEPLOYMENT DURING AN EMBOLIZATION PROCEDURE FOR A CEREBRAL ANEURYSM MEASURING 12MM. THE MEDTRONIC FLOW DIVERTER AND MICROCATHETER WERE REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE ANEURYSM WAS UNRUPTURED AND SACCULAR. ALL OTHER DETAILS OF THE ANEURYSM WERE UNKNOWN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7969208 ↗
• MalfunctionJul 6, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PFLEX (4.75 MM X 25 MM) AND AN UNKNOWN PIPELINE PRODUCT FAILED TO OPEN DURING A PROCEDURE TO ADDRESS AN UNRUPTURED FUSIFORM ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA) POSTERIOR COMMUNICATING ARTERY SEGMENT. IT WAS CONFIRMED THAT THE PIPELINE DEVICE AND ITS ACCESSORIES WERE PREPPED ACCORDING TO THEIR INDICATIONS FOR USE (IFU). IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO OPEN/FLOWER THE PIPELINE DEVICE IN THE M1 SEGMENT MULTIPLE TIMES, BUT THE DEVICE WOULD NOT OPEN AFTER UNSHEATHING 2/3 OF THE DEVICE; GREATER THAN 50% OF THE DEVICE WAS DEPLOYED. THE HCP THEN ATTEMPTED TO POSITION THE DEVICE IN THE ICA, BUT IT AGAIN WOULD NOT OPEN. THE DEVICE WAS REMOVED FROM THE MICROCATHETER AND RHV, AND IT WAS NOTED THAT THE PROXIMAL END OF THE DEVICE LOOKED CRIMPED; HOWEVER, ONLY THE MIDDLE PART OF THE PRODUCT WAS PLACED IN A BEND. ANOTHER DEVICE OF THE SAME SIZE WAS USED AND IT ALSO WOULD NOT OPEN. THE SAME DIAGNOSTICS/TROUBLESHOOTING WERE PERFORMED ON THE REPLACEMENT DEVICE. IT WAS NOTED, HOWEVER, THAT THE REPLACEMENT DEVICE APPEARED NORMAL UPON REMOVAL AND WAS NOT CRIMPED. A 4.5MM X 25MM PIPELINE DEVICE WAS THEN USED AND OPEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667701 ↗

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