PIPELINE PED-475-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847536016804), received between Dec 7, 2018 and Jun 5, 2024 — classified as 1 death, 18 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (11 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX STENT THAT FAILED TO OPEN AND WAS DAMAGED AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A C7 POSTERIOR COMMUNICATING ARTERY SEGMENT UNRUPTURED SACCULAR LATERAL WALL ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 6.8MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS PASSED ACROSS THE ANEURYSM AND DEPLOYMENT OF THE PIPELINE STENT WAS INITIATED ACCORDING TO STANDARD PROCEDURE. AFTER TRYING TO OPEN THE PIPELINE STENT IN THE M1 STRAIGHT SEGMENT SEVERAL TIME, THE DISTAL END STILL COULD NOT BE OPENED SMOOTHLY SO IT WAS REMOVED FROM THE PATIENT'S BODY. AFTER TAKING OUT THE PIPELINE, IT WAS FOUND THAT THE DISTAL END OF THE STENT WAS DAMAGED. A PIPELINE SHIELD (MODEL: PED2-4.75-25) WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471258 ↗
• DeathAug 23, 2023Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING NO FRICTION OR RESISTANCE ENCOUNTERED DURING DEPLOYMENT OF THE FIRST PIPELINE. THE PIPELINE DEVICES WERE NOT RESHEATHED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17604370 ↗
• MalfunctionDec 22, 2021Unintended Ejection; Physical Resistance/Sticking; Unintended Ejection; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE STENT DELIVERY WAS NOT SMOOTH DUE TO RESISTANCE IN THE CATHETER. WHEN THE STENT WAS RETRACTED INTO THE MICROCATHETER, IT WAS FOUND TO HAVE GREAT RESISTANCE. THE STENT COULD NOT MOVE FORWARD OR BACKWARDS IN THE CATHETER. AFTER REPEATED ATTEMPTS, THE SURGEON PULLED OFF THE GUIDEWIRE OF THE STENT. NEITHER THE STENT OF MICROCATHETER WERE IMPLANTED, AND THE STENT WAS REMOVED WITH THE MICROCATHETER. REPLACEMENT PRODUCTS 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 SHOWED RETENTION OF CONTRAST AGENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 9.5 MM AND A 4.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT PIPELINE WAS INSIDE THE MICROCATHETER MARKSMAN, AND IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062566 ↗
• MalfunctionOct 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT A PIPELINE HAD RESISTANCE AT THE PHENOM CATHETER HUB AND COULD NOT BE PUSHED OUT. TWO NAVIEN CATHETERS WERE ALSO NOTED TO HAVE RESISTANCE AT THE HUB. IT WAS NOTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WITH HEPARINIZED SALINE WAS ADMINISTERED PER IFU. NO CATHETER OR PIPELINE PUSHWIRE DAMAGE WAS NOTED. IT WAS NOTED THE TIP OF THE SHEATH WAS SEATED SECURELY IN THE HUB. THE PATIENT WITH MODERATE VESSEL TORTUOSITY WAS UNDERGOING A STENT IMPLANTATION PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO RESISTANCE WITH THE TWO NAVIEN CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12659741 ↗
• MalfunctionSep 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE PIPELINE COULD NOT BE PUSHED OUT OF THE MARKSMAN MICROCATHETER DUE TO RESISTANCE IN THE DISTAL SEGMENT. THERE WAS NO DAMAGE TO THE PUSHWIRE OR CATHETER, AND A CONTINUOUS FLUSH HAD BEEN USED. A REPLACEMENT MARKSMAN WAS USE, AND THE PROCEDURE 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. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED SLOWED BLOOD FLOW IN ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 14 MM AND A 9MM 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 1. ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456399 ↗
• MalfunctionSep 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE WHICH BECAME STUCK AT THE DISTAL END OF THE PHENOM CATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT OPHTHALMIC ARTERY SEGMENT. THE ANEURYSM MAX DIAMETER WAS 10.21MM AND THE NECK DIAMETER WAS 8.77MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PHENOM WAS NAVIGATED SMOOTHLY AND IN PLACE IN THE M2 AND THE PIPELINE WAS DELIVERED SMOOTHLY. IN THE M1 SEGMENT, THE PIPELINE DISTAL TIP OPENED WELL. PULLING BACK AND P OSITIONING WAS GOING WELL. HOWEVER, IT WAS FOUND DURING THE DELIVERY THAT THE PIPELINE COULD NOT BE PUSHED OUT FURTHER AND THE PHENOM CATHETER ALSO COULD NOT BE WITHDRAWN TO DEPLOY THE PIPELINE. THE PHYSICIAN ATTEMPTED TO RELEASE THE STACK IN THE SYSTEM BUT IT DID NOT RESOLVE THE RESISTANCE. AFTER REPEATED ATTEMPTS, THERE WAS NO CHANGE AND THE PIPELINE REMAINED STUCK IN THE DISTAL END OF THE CATHETER. THE PHENOM CATHETER AND THE PIPELINE WERE WITHDRAWN TOGETHER FROM THE PATIENT'S BODY AND IT WAS FOUND THAT THE TWO DEVICES WERE STUCK TOGETHER AND COULD NOT BE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454345 ↗
• MalfunctionSep 2, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414505 ↗
• MalfunctionAug 9, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS DELIVERED SMOOTHLY TO THE END OF THE MARKSMAN MICROCATHETER. THE DISTAL TIP OF THE STENT WAS DEPLOYED, BUT IT COULD NOT BE OPENED. AN ADDITIONAL 15 MM OF THE STENT WAS DEPLOYED, BUT THE TIP END AND THE DEPLOYED PART COULD NOT OPEN. AFTER REPEATED ATTEMPTS, THE SYSTEM WAS WITHDRAWN. IT WAS NOTED THE STENT WAS NOT POSITIONED IN A BEND, RESHEATHING WAS PERFORMED LESS THAN THREE TIMES, AND THERE WERE NO ADDITIONAL STEPS TAKEN TO RESOLVE THE ISSUE. 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 LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 10.4 MM AND A 7.4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298807 ↗
• MalfunctionMay 18, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN DID NOT BELIEVE THE PIPELINE TO BE FAULTY. IT WAS A DIFFICULT CASE, AND THE PIPELINE HAD TO BE DEPLOYED AROUND AN ACUTE TURN WHICH WAS MOST LIKELY THE CAUSE OF THE DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845585 ↗
• MalfunctionApr 26, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE MARKSMAN MICROCATHETER AND FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT CAVERNOUS SINUS SEGMENT. THE MAX DIAMETER WAS 23MM, AND THE NECK DIAMETER WAS 16MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.5MM DISTAL AND 4.88MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED FOR 7 DAYS, AND MORE THAN 90 FOR THROMBUS ELASTICITY. IT WAS REPORTED THAT THE TIP OF THE PIPELINE FAILED TO ADHERE TO THE WALL AND WAS STUCK WITH THE MARKSMAN DURING THE DEPLOYING PROCESS. AFTER TAKING IT OUT, IT WAS FOUND THAT THE TIP OF THE STENT HAD BEEN IRREGULAR. THE DISTAL TIP OF THE PIPELINE HAD FAILED TO OPEN. THE PIPELINE WAS NOT POSITIONED IN A BEND WHEN IT FAILED TO OPEN, AND MORE THAN 50% HAD BEEN DEPLOYED AT THE TIME. THE PHYSICIAN RESHEATHED 2 OR LESS TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE AND MARKSMAN CATHETER WERE REMOVED FROM THE PATIENT AND REPLACED. AFTER THE NEW PIPELINE WAS IMPLANTED, ANGIOGRAPHIC RESULTS SHOWED THE CONTRAST AGENT STAYED IMMEDIATELY. THE PATIENT DID NOT EXPERIENCE ANY INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729556 ↗
• MalfunctionDec 21, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS RESISTANCE FELT WITH ALL FOUR PIPELINE DEVICES. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE, AND NO OTHER TREATMENT WAS REQUIRED FOR THE PATIENT AT THE TIME OF THE REPORT. IT WAS NOTED THE PHYSICIAN MAY RESCHEDULE THE PATIENT WITH A DIFFERENT MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047569 ↗
• MalfunctionNov 20, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO PIPELINE DEVICES FAILED TO OPEN DURING A DEPLOYMENT. THE COMPLAINT PIPELINES WERE BOTH RESHEATHED, AND REMOVED FROM THE PATIENT'S BODY WITH THE MICROCATHETER. ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). NO OTHER EVENT, OR PATIENT INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10875378 ↗
• MalfunctionSep 8, 2020Unintended Ejection; Activation Failure; Physical Resistance/Sticking; Unintended Ejection; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE SEGMENT OF THE PIPELINE FAILED TO OPEN OR ACHIEVE FULL WALL APPOSITION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY CHOROIDAL SEGMENT WITH A MAX DIAMETER OF 15MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE MICROCATHETER WAS PARKED DISTALLY TO THE ANEURYSM. THE PIPELINE WAS THEN UNSHEATHED FROM THE MIDDLE CEREBRAL ARTERY (MCA) TO THE NECK OF THE ANEURYSM. HOWEVER, THE MIDDLE SECTION OF THE DEVICE WAS NOT UNSHEATHING AND OPENING WITH PROPER WALL APPOSITION. THE DOCTOR DECIDED TO RESHEATH THE PIPELINE AND REDEPLOY. THE CHALLENGED WAS OBSERVED AGAIN, AND IT WAS OBSERVED THAT THE DEVICE WAS STUCK IN THE MICROCATHETER INTHE SECOND ATTEMPT AT DEPLOYMENT. IT WAS UNKNOWN IF THE DEVICE WAS IN A BEND, MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, RESHEATHING WAS DONE LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE DEVICE WAS RESHEATHED AND REMOVED FROM THE PATIENT. A REPL

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

  MAUDE report 10504614 ↗
• MalfunctionSep 1, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THE PIPELINE 5.00MM X 35MM WOULD NOT OPEN COMPLETELY IN AN EXTREMELY ACUTE ANGLE ANTERIOR GENU DISTAL TO THE ANEURYSM. IT WAS NOTED THAT THE DEVICE FAILED TO OPEN 6-8MM FROM THE DISTAL END IN THE ANTERIOR GENU. NOT HAPPY WITH APPOSITION IN THE ANTERIOR GENU, THE PHYSICIAN REMOVED THE PIPELINE 5.00MM X 35MM FROM THE PATIENT AND ATTEMPTED WITH THE PIPELINE 4.75MM X 30MM: HOWEVER, THE PIPELINE 4.75MM X 30MM BEHAVED THE SAME IN THE EXTREMELY TORTUOUS GENU. THE PIPELINE 4.75MM X 30MM WAS REMOVED FROM THE PATIENT, AND THEN THE PHYSICIAN SUCCESSFULLY DEPLOYED THE SHORTER PIPELINE 4.50MM X 20MM LANDING JUST PROXIMAL TO THE ANTERIOR GENU. IT WAS STATED THAT THE DISTAL SECTION OF THE PIPELINES WERE POSITIONED IN A BEND, AND LESS THAN 50% OF BOTH PIPELINES HAD BEEN DEPLOY WHEN IT FAILED TO OPEN. BOTH PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINES. BOTH PIPELINES WERE RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE RIGHT CAVERNOUS WITH A MAX DIAMETER OF 16MM AND A NECK DIAMETER OF 4-5MM. THE DISTAL L ANDING ZONE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10479798 ↗
• MalfunctionAug 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX EMBOLIZATION DEVICE (PED) WAS STUCK IN THE DISTAL SEGMENT OF THE MARKSMAN MICR OCATHETER AFTER APPROXIMATELY ONE THIRD OF THE PIPELINE WAS DEPLOYED AND IT COULD NOT BE RELEASED ANYMORE. IT WAS NOT POSSIBLE TO RETRIEVE IT ALSO. THE STENT AND MICROCATHETER HAD TO BE RETRIEVED AS A WHOLE. A NEW PIPELINE AND MARKSMAN WERE USED AND THE MARKSMAN WAS ABLE TO BE IN PLACE, BUT THE PIPELINE COULD NOT BE IN PLACE. THIS NEW ENTIRE SYSTEM WAS REMOVED AND THE DISTAL SEGMENT OF THE NEW MARKSMAN MICROCATHETER WAS FOUND TO BE ACCORDIONED. A THIRD MARKSMAN WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED AMORPHOUS ANEURYSM MEASURING 5.9MM X 12MM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE DISTAL AND PROXIMAL LANDING ZONE WAS 3.69MM X 4.67MM. THE VASCULATURE WAS SEVERE IN TORTUOSITY. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY (DAPT), BUT PRU LEVEL WAS UNKNOWN. ACCESS WAS THROUGH THE FEMORAL ARTERY WITH DIAMETER OF 8.8MM. THE CATHETER WAS FLUSHED WITH HEPARINIZED SALINE. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM, BUT IT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10368835 ↗
• MalfunctionOct 7, 2019Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT OF UNRUPTURED, SACCULAR RIGHT INTERNAL CAROTID ARTERY SUPRACLINOID GIANT WIDE NECK ANEURYSM, MEASURING 24MMX7MM. LANDING ZONE DISTAL 3.2MM, PROXIMAL 5.3MM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. IT WAS REPORTED THAT AFTER GETTING INTO THE M1 SEGMENT, PHYSICIAN EXPOSED THE DEVICE. INITIALLY THE PTFE SLEEVES DID NOT OPEN UP BUT AFTER FEW MANEUVERS HE WAS ABLE TO OPEN THE PTFE SLEEVES AND THE DISTAL PART OF THE DEVICE. CONTINUED TO DEPLOY THE DEVICE. WHILE DEPLOYING THE DEVICE AT THE NECK OF THE ANEURYSM, THE DEVICE DID NOT OPEN UP . RE-SHEATH THE DEVICE AND DEPLOYED IT AGAIN STILL THE DEVICE WAS NOT OPENED. AFTER LOT OF MANEUVERS DEVICE DID NOT OPENED UP. HE DECIDED TO TAKE OUT THE DEVICE. WHILE TAKING OUT THE DEVICE FROM THE MICRO CATHETER DEVICE GOT DEPLOYED AT THE HUB OF MICRO CATHETER. PED WAS REPLACED BY ANOTHER FLOW DIVERTER OF DIFFERENT MANUFACTURER AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WERE NOT ANY IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162093 ↗
• MalfunctionMay 1, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX FAILURE TO OPEN. THE PATIENT WAS UNDERGOING PIPELINE FLEX EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT INTERNAL CAROTID ARTERY. MEASURING 14MM X 8MM, LANDING ZONE DISTAL 4.2MM PROXIMAL 5.1MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS UNSHEATHED AND WAS UNABLE TO OPEN ON THE DISTAL END. LESS THAN 50% THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY PLACING A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569658 ↗
• MalfunctionDec 7, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THIS REPORTED PIPELINE FLEX PUSHWIRE BROKE DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING FLOW DIVERSION OF AN UNRUPTURED A MEDIUM SIZE UNRUPTURED SACCULAR ANEURYSM LOCATED IN CAVERNOUS SEGMENT IN RIGHT INTERNAL CAROTID ARTERY. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO DELIVER THIS PIPELINE THROUGH NON-MEDTRONIC CATHETER BUT UNABLE TO DELIVERED THROUGH THE CATHETER AND THE PUSHWIRE BROKE ON PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT AND NO HARM OR DEVICE WAS LEFT IN PATIENT. THE PHYSICIAN THEN EXCHANGED FOR A MEDTRONIC CATHETER AND SUCCESSFULLY DEPLOYED THIRD PIPELINE AND COMPLETED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142046 ↗
• MalfunctionDec 7, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THIS REPORTED PIPELINE FLEX PUSHWIRE BROKE DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING FLOW DIVERSION OF AN UNRUPTURED A MEDIUM SIZE UNRUPTURED SACCULAR ANEURYSM LOCATED IN CAVERNOUS SEGMENT IN RIGHT INTERNAL CAROTID ARTERY. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO DELIVER THIS PIPELINE THROUGH NON-MEDTRONIC CATHETER BUT UNABLE TO DELIVERED THROUGH THE CATHETER AND THE PUSHWIRE BROKE ON PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT AND NO HARM OR DEVICE WAS LEFT IN PATIENT. THE PHYSICIAN THEN EXCHANGED FOR A MEDTRONIC CATHETER AND SUCCESSFULLY DEPLOYED THIRD PIPELINE AND COMPLETED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142024 ↗

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-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