PIPELINE PED-400-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536015999), received between Jul 25, 2019 and Jul 31, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 18, 2026.

Recalls naming this device

1. Jul 13, 2021Class IOpen, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS IN PLACE, AND THE PIPELINE WAS DIFFICULT TO PUSH OUT. MANY ATTEMPTS WERE PERFORMED, BUT THE PIPELINE CONTINUED TO EXPERIENCE RESISTANCE IN THE DISTAL SEGMENT OF THE CATHETER. IT WAS STATED THAT IT WAS NOT STUCK, A CONTINUOUS FLUSH WAS USED, AND NO DAMAGE WAS OBSERVED. A NEW STENT WAS SUCCESSFULLY DELIVERED THROUGH THE CATHETER 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427888 ↗
• InjuryJan 9, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE GUIDE WIRE WAS BROUGHT UP TO THE INTERNAL CAROTID ARTERY C3 WITH THE PHENOM27 AND THE NAVIEN, THERE WAS RESISTANCE AND THE TENSION OF THE CATHETER WAS ADJUSTED SO IT COULD CONTINUE TO GO UP TO THE ANEURYSM. THE GUIDE WIRE FOLLOWED THE PHENOM27 TO FIND THE OUTFLOW TRACT. THIS WAS ATTEMPTED SEVERAL TIMES, THE GUIDE WIRE AND CATHETER WERE WITHDRAWN AND THEY PLANNED TO REPLACED THE GUIDE WIRE, HOWEVER, IT WAS FOUND THE PHENOM27 TIP END WAS KINKED. THE MARKSMAN AND GUIDE WIRE WERE REPLACED TO CONTINUE THE OPERATION. DURING THE SECOND ATTEMPT, THE GUIDE WIRE AND CATHETER SMOOTHLY REACHED THE BRAIN M2, AND THE PIPELINE 4.25-33.5 SMOOTHLY ASCENDED FROM THE C6 TO C7. ONCE AGAIN, RESISTANCE INCREASED AND ANGIOGRAPHY CONSIDERED THE TORTUOUS BLOOD VESSEL AND PLANNED TO DEPLOY IT IN SITU. NEXT, THE SURGEON WITHDREW THE MARKSMAN AND FOUND THE CATHETER COULD NOT BE MOVED. THE SURGEON PUSHED THE NAVIEN TO GO UPPER TO RAISE THE PROXIMAL SUPPORT AND THEN CONTINUED TO WITHDRAW THE MARKSMAN. IT WAS FOUND THAT THE CAT HETER COULD NOT MOVE, THE STENT WAS PUSHED FORWARD WITH GREAT RESISTANCE AND IT COULD NOT BE PUSHED FORWARD ANY MORE. THE STENT AND CATHETER WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13201204 ↗
• MalfunctionAug 24, 2021Unintended Ejection; Material Deformation; Physical Resistance/Sticking; Unintended Ejection; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE PHENOM 27 MICROCATHETER AND THE PUSHER WIRE KINKED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 10MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.5MM DISTAL AND 4.0MM PROXIMAL. THE ACCESS VESSEL WAS THE ICA, WHICH WAS 5MM IN DIAMETER. IT WAS REPORTED THAT THERE WAS SEVERE RESISTANCE WHILE DELIVERING THE PIPELINE TO THE DESIRED LANDING ZONE. WHILE ATTEMPTING TO POSITION THE DISTAL PORTION OF THE DEVICE INTO PLACE, THE PUSHWIRE BENT AND KINKED. THE PROXIMAL PART OF THE PUSHWIRE WAS BENT INTO 90 DEGREES. DURING REMOVAL, THE PIPELINE DEPLOYED WITHIN THE HUB OF THE CATHETER. A CONTINUOUS FLUSH WAS USED. THE PIPELINE HAD NOT BECOME STUCK. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE TWO SUBSEQUENT PIPELINES WERE DEPLOYED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM PLUS GUIDE CATHETER. ADDITIONAL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360441 ↗
• MalfunctionNov 27, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE DELIVERY OF THE PIPELINE IN THE MICROCATHETER, WHEN PASSING THROUGH THE BIFURCATION OF THE INTERNAL CAROTID ARTERY, THE PIPELINE WAS STUCK AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT BE PUSHED FORWARD OR RETRIEVED. THEREFORE, THE PIPELINE AND MICROCATHETER WERE WITHDRAWN FROM THE BODY AS A WHOLE, AND THE DISTAL END OF THE MICROCATHETER WAS FOUND TO BE ACCORDION-LIKE DAMAGE. IT WAS NOTED THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, AMORPHOUS ANEURYSM WITH A MAX DIAMETER OF 18.86MM AND A NECK DIAMETER OF 16.43MM. THE DISTAL LANDING ZONE WAS 3.17MM, AND THE PROXIMAL LANDING ZONE WAS 3.65MM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, AND THE ACCESS VESSEL DIAMETER WAS 7.9MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE PRU LEVEL WAS 0. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS PARTIAL RESIDUE. 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 10913911 ↗
• MalfunctionFeb 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT PIPELINE FLEX DEVICE ENCOUNTERED RESISTANCE WITHIN THE CATHETER. PED-400-30 WAS REPORTED TO HAVE ENCOUNTERED RESISTANCE WITHIN THE PROXIMAL SECTION OF THE CATHETER. THE CATHETER WAS FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF THE CATHETER WAS DAMAGED. THE PUSHWIRE WAS NOT DAMAGED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF A RUPTURED, SACCULAR, LEFT VERTEBRAL ARTERY ANEURYSM. THE MAX DIAMETER WAS 7 MM AND THE NECK WAS 6 MM. THE DISTAL LANDING ZONE WAS 3.9 MM AND THE PROXIMAL WAS 4.02 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727299 ↗
• MalfunctionJan 6, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX (PED) FAILED TO EXPAND IN THE MIDDLE SECTION. PED 4X30 WAS LOADED AND THE DEVICE WAS PULLED BACK BELOW THE ICA BIFURCATION. THE PED DEVICE OPENED UP IN THE STRAIGHT SEGMENT OF THE PROXIMAL TOP P.COM. 7-8 MM OF THE DEVICE OPENED UP WELL. THE SYSTEM WAS PULLED BACK AND PHYSICIAN DECIDED TO CONTINUE THE DEPLOYMENT. AT THE OPHTHALMIC BEND THE DEVICE DID NOT OPENED. DEVICE WAS RE-SHEATHED AND A SECOND ATTEMPT TO OPEN THE DEVICE WAS MADE BUT STILL THE DEVICE DI NOT OPENED. THE DEVICE WAS RESHEATHED. ANOTHER ATTEMPT WAS MADE TO OPEN THE DEVICE BUT STILL IT DID NOT OPEN. THE DEVICE WAS TAKEN OUT ALONG WITH MICRO CATHETER AND ANOTHER PED WAS USED. THE DEVICE WAS LESS THAN 50% DEPLOYED WHEN IT FAILED TO OPEN. LESS THAN OR EQUAL TO 2 TIMES THE PED WAS RESHEATHED. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT OPHTHALMIC ARTERY, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 14MM AND THE NECK WAS 4MM. THE DISTAL LANDING ZONE WAS 3.4MM AND THE PROXIMAL SECTION WAS 4.1MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554479 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT RESISTANCE WAS FELT, CAUSING THE PIPELINE TO BECOME STUCK AT THE MICROCATHETER HUB. UPON RETRIEVING THE DEVICE IT WAS NOTICED THAT THE PIPELINE WAS SEVERELY BENT AND FELL OFF AT THE PROXIMAL END OF THE MICROCATHETER AFTER WITHDRAWAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, AMORPHOUS ANEURYSM WITH A MAX DIAMETER OF 6MM AND A NECK DIAMETER OF 6MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THE PRU LEVEL WAS NOT MEASURED. POST ANGIOGRAPHIC RESULTS SHOWED PARTIAL RESIDUE. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO CATHETER OR PUSHWIRE DAMAGE, THE CATHETER WAS CONTINUED TO BE USED. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9011354 ↗
• MalfunctionJul 25, 2019Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX DID NOT OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF A MEDIUM UNRUPTURED SACCULAR RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM, MEASURING 15.67MM X 12.22MM. LANDING ZONE DISTAL 4.12MM, PROXIMAL 4.20. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS ADVANCED THROUGH A MARKSMAN WITH RESISTANCE. AT DEPLOYMENT, THE TIP OF THE PIPELINE FLEX DID NOT OPEN. THE DEVICE WAS ATTEMPTED TO BE RESHEATHED, WITH WAS UNSUCCESSFUL. THE SYSTEM WAS REMOVED. AFTER REMOVAL, IT WAS FOUND THAT THE TIP OF THE PIPELINE FLEX HAD BURRS AND THE MICROCATHETER WAS ALSO DAMAGED. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8829217 ↗

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-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-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