PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000284466), received between Jun 11, 2021 and Sep 23, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (10 reports).

12 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 18, 2026.

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.

• MalfunctionSep 23, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Activation Failure; Physical Resistance/Sticking

  Medtronic received a report of Pipeline failure to open and a Navien kink. The patient was undergoing flow-diverting mesh stent implantation surgery for treatment of a fusiform, unruptured, left clinoid segment aneurysm with a max diameter of 9 mm and a 4.9 mm neck diameter. The landing zone was 3.9 mm distally and 4.2 mm proximally. The access vessel was the femoral artery with a diameter of 20 mm. It was noted the patient's vessel tortuosity was severe. The angiographic result post procedure showed a clinoid segment aneurysm. It was reported that the patient was approached via the femoral artery, and the vessel was severely tortuous. The stent catheter was delivered into position, and the flow-diverting mesh Pipeline stent was advanced to the straight segment. When deployment was performed, the distal end could not open. Repeated adjustments were unsuccessful. It was removed and then replaced. During delivery of the intermediate Navien catheter, there was significant resistance at the tip end. It could not be positioned. After withdrawal, a kink was found at the tip end of the Navien, and it was replaced. The kink was the distal end. The Pipeline was not used for an indication th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869251 ↗
• MalfunctionMar 18, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE'S DELIVERY ROD BECAME STUCK AT THE DISTAL END OF THE PHENOM MICROCATHETER AND COULD NOT BE WITHDRAWN. THE PATIENT WAS UNDERGOING ANEURYSM BLOOD FLOW-DIVERTING STENT IMPLANTATION SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS REPORTED THAT A BLOOD FLOW-DIVERTING STENT IMPLANTATION WAS PERFORMED FOR AN ANEURYSM IN THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY. AFTER THE MICROCATHETER WAS POSITIONED, A PED2-425-25 WAS SUCCESSFULLY DEPLOYED. AFTER STENT DEPLOYMENT, THE DELIVERY ROD WAS RETRIEVED THROUGH THE PHENOM 27 MICROCATHETER; HOWEVER, THE DELIVERY ROD BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT BE WITHDRAWN. THE SYSTEM WAS REMOVED ENTIRELY FROM THE PATIENT, AND ANOTHER MICROCATHETER WAS USED TO CONTINUE THE SUBSEQUENT PROCEDURE. THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626691 ↗
• MalfunctionJan 14, 2026Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE THE CAUSE OF THE FAILURE TO ADHERE TO WALL AND FAILURE TO RETRIEVE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE DISTAL END OF THE DELIVERY WIRE WAS KINKED. THE MIDDLE SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO ADHERE. ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO ADHERE THE PIPELINE INCLUDED ATTEMPTS USING PUSHING AND PULLING MOTIONS. THE PHENOM WAS CONTINUED TO BE USED TO DEPLOY ANOTHER PIPELINE AND THEN STERILIZED AND HANDLED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067013 ↗
• MalfunctionOct 16, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT IMPLANTED, IT WAS REMOVED FROM THE PATIENT AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED. IT WAS NOTED THERE WAS NO ISSUE WITH THE MICROCATHETER WHICH WAS USED TO DELIVER THE SUBSEQUENT PIPELINE WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310768 ↗
• MalfunctionAug 29, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE PIPELINE DID NOT OPEN IN THE DISTAL SECTION. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE, SPECIFICALLY, THE PHYSICIAN PUSHED THE INTERMEDIATE CATHETER TO GO UPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923891 ↗
• MalfunctionJul 21, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS UNDETERMINED. THE PIPELINE DID NOT OPEN AT THE DISTAL SECTION. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. IT WAS UNKNOWN WHETHER THERE WERE ANY ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE OR ANY DEVICE ISSUES WITH THE PHENOM. IT WAS CLARIFIED THAT THE VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554904 ↗
• MalfunctionJul 3, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS HARD TO DETERMINE. IT WAS SUSPECTED THAT IT MAY BE RELATED TO THE STENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398185 ↗
• MalfunctionMar 3, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE STENT HAD RESISTANCE IN THE DISTAL SECTION FO THE PHENON CATHETER AND FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE RIGHT CAVERNOUS SINUS SEGMENT. THE MAX DIAMETER WAS 13MM AND THE NECK DIAMETER WAS 5.1MM. THE DISTAL LANDING ZONE WAS 3.89MM AND THE PROXIMAL LANDING ZONE WAS 4.23MM. VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509786 ↗
• MalfunctionJun 20, 2024Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN AND WAS STUCK RESHEATHING IN THE PHENOM27 CATHETER. PHYSICIAN PREPPED THE DEVICE PER INSTRUCTIONS FOR USE (IFU). HE BEGAN TO DEPLOY THE DEVICE IN THE DISTAL M1 SEGMENT. THE DEVICE DID NOT WANT TO OPEN DISTALLY SO WE RESHEATHED AND UNSHEATHED AGAIN. DEVICE BEGAN TO OPEN. AS HE DEPLOYED AND CAME AROUND THE TERMINUS HE DETERMINED THAT HE NEEDED TO RESHEATH THE DEVICE AND DEPLOY MORE DISTALLY. THE PHENOM 27 MICRO CATHETER WOULD NOT ADVANCE OVER THE PIPELINE DEVICE TO RESHEATH. THE PHYSICIAN HAD TO PULL OUT THE PHENOM 27 AND PIPELINE DEVICE AS A UNIT. IT WAS STUCK IN THE DISTAL SECTION OF THE CATHETER DURING RESHEATHING. THE PHYSICAIN RELEASED THE LOAD IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE. THE ISSUE DID NOT RESOLVE. THE CATHETER AND PUSHWIRE WERE NOT DAMAGED. THEY THEN OPENED A NEW PHENOM 27 AND PIPELINE 4.25X25. NO ISSUES WITH THE DEVICE OPENING AT ANY POINT IN TIME AND DEVICE WAS DEPLOYED/IMPLANTED. THE DEVICES WERE PREPARED ACCORDING TO THE ISNTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, FUSIFORM ANEUERYSM IN THE MIDDLE CEREBRAL ARTERY (MCA). THE MAX DIAMETER WAS 7MM AND THE NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571444 ↗
• MalfunctionMar 18, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING ANEURYSM BLOOD FLOW DIVERSION DENSE MESH STENT IMPLANTATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 6.49 MM AND A 5.37 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.64 MM AND PROXIMAL: 4.19 MM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 4.21 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AND THE PRU LEVEL WAS 0. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT PED2-425-25 WAS PUSHED TO GO UPPER INTO PLACE THROUGH THE PHENOM27 MICROCATHETER, AND THE STENT WAS DEPLOYED. AFTER THE TIP END OF THE STENT WAS DEPLOYED, IT FAILED TO OPEN SMOOTHLY. TRIED TO PUSH THE INTERMEDIATE CATHETER TO GO UPPER AND RETRIEVED THE STENT. AFTER DEPLOYING THE TIP END AGAIN, DEPLOYING MORE LENGTH STILL DID NOT SOLVE THE PROBLEM. THE TIP END OF THE STENT STILL COULD NOT BE OPENED AFTER REPEATED PUSHING AND PULLING, AND THEN THE STENT AND MICROCATHETER WERE WITHDRAWN AS A WHOLE. THE NEW STENT PED2-425-20 AND THE NEW PHENOM27 CATHETER WERE REPLACED, AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920906 ↗
• MalfunctionSep 5, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL END OF THE PIPELINE DID NOT OPEN. ACCORDING TO THE ROUTINE OPERATION, PLACED IN THE RELATIVELY STRAIGHT VESSEL OF THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PIPELINE WAS RETRIEVED THE DISTAL END OF THE STENT AND DEPLOYED IT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686489 ↗
• MalfunctionJun 11, 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 RIGHT ICA. THE MAX DIAMETER WAS 14MM, AND THE NECK DIAMETER WAS 8MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.12MM DISTAL AND 4.16MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 80. IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY THE PIPELINE, THE DISTAL END HAD THE "FLOWER EFFECT." THE DOCTOR RECAPTURED IT AND TRIED AGAIN AND WAS ABLE TO GET THE DISTAL END TO OPEN WITH THE WIRE/CATHETER. THE DEVICE WAS PLACED SUCCESSFULLY, BUT WITH MUCH MANIPULATION TO GET IT TO OPEN. THE PIPELINE WAS NOT POSITIONED IN A BEND, AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED 2 OR LESS TIMES. FULL WALL APPOSITION WAS ACHIEVED, AND ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE GREAT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987281 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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-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