PIPELINE PED-450-35 (UDI 00847536016569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536016569), received between Mar 23, 2017 and Oct 11, 2022 — classified as 1 death, 14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Activation Failure; Activation Failure

  2022-OCT-07 MPXR 991711 (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION THAT A PED PIPELINE DEVICE FAILED TO OPEN IN THE DISTAL SECTION. AFTER THE CATHETER WAS IN PLACE, THE PED-450-35 STENT WAS DEPLOYED. WHEN IT WAS DEPLOYED, IT WAS FOUND THAT THE TIP END OF THE STENT COULD NOT BE OPENED. LATER, REPLACED WITH PED-450-30 STENT, AND IT WAS DEPLOYED NORMALLY. IT BELONGED TO THE NORMAL OPERATIONAND THE PATIENT HAD NO ABNORMALITY. THE DISTAL SECTION OF THE PIPELINE WAS POSITIONED IN A BEND. LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE CAVERNOUS SINUS SEGMENT.THE MAX DIAMETER WAS 29MM AND THE NECK DIAMETER WAS 14MM. THE DISTAL LANDING ZONE WAS 3.92MM. THE PROXIMAL LANDING ZONE WAS 5.3MM. VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHY WAS IN GOOD CONDITION POST PROCEDURE. NO PATIENT SYMPTOM OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578036 ↗
• MalfunctionAug 22, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY AND THE MARKSMAN MICROCATHETER WAS KINKED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE CAVERNOUS SINUS SEGMENT. THE MAX DIAMETER WAS 12MM, AND THE NECK DIAMETER WAS 9MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.5MM DISTAL AND 4.5MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE AS WITHDRAWN IN THE MICROCATHETER 3 TIMES AND FAILED TO DEPLOY. UNDER DSA IMAGING THE TIP END OF THE PIPELINE WAS OBSERVED TO HAVE A "SHOFAR FEATURE." AFTER BEING WITHDRAWN FROM THE BODY, THE TIP END OF THE STENT WAS FOUND TO BE WORN AND THE DISTAL PART OF THE MARKSMAN MICROCATHETER WAS KINKED. THE PIPELINE WAS POSITIONED IN A BEND AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE DEVICES WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE NORMAL. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272096 ↗
• MalfunctionJun 24, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE SECTION OF THE PIPELINE COULD NOT BE OPENED. THE PIPELINE AND PHENOM 27 CATHETER WERE REPLACED WITH SIMILAR MODELS AND THE SURGERY WAS COMPLETED. THE PIPELINE WAS POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE DEVICE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT UNDERWENT BLOOD FLOW GUIDING DEVICE FOR TREATMENT OF AN ANEURYSM. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE: 6F LONG SHEATH, 5F 115NAVIEN, ECHELON 10 MICROCATHETER, SYNCHRO 14 GUIDEWIRE AND MINIMALLY INVASIVE COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806579 ↗
• MalfunctionAug 20, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, FOREIGN) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE OF THE PIPELINE PUSHWIRE WAS KINKED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE CAVERNOUS SINUS OF THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 16MM, AND THE NECK DIAMETER WAS 8MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 10MM DISTAL AND 10MM PROXIMAL. IT WAS REPORTED THAT DURING THE DELIVERY OF THE STENT, THE PUSH ROD WAS FOUND TO BE BENT IN THE MICROCATHETER, CAUSING THE STENT TO BE UNABLE TO REACH THE LESION POSITION. THERE HAD BEEN NO FRICTION OR DIFFICULTY. THE PIPELINE WAS REMOVED FROM THE PATIENT, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE ANEURYSM WAS FILLED WITH COILS AND WAS NOT DEVELOPED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A COOK 7F SHEATH, JOHNSON & JOHNSON GUIDE CATHETER, MARKSMAN MICROCATHETER, NAVIEN CATHETER, SYNCHRO 14 GUIDEWIRE, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350136 ↗
• MalfunctionMay 7, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE HAD BEEN DEPLOYED IN A STRAIGHT VASCULAR SEGMENT AND NOT A BEND. IT WAS UNKNOWN HOW MANY ATTEMPTS TO RE-SHEATH THE PIPELINE WERE PERFORMED. AFTER THE PIPELINE WAS RETRIEVED, IT WAS DEPLOYED AGAIN, PULLED BACK AND RE-POSITIONED, BUT EVERY ATTEMPT FAILED. THERE HADN'T BEEN ANY RESISTANCE NOTED DURING DELIVERY OR RETRIEVAL THAT MAY HAVE CONTRIBUTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791017 ↗
• MalfunctionMar 7, 2021Material Deformation; Unintended Movement; Physical Resistance/Sticking; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DUE TO THE PATIENT'S VESSEL TORTUOSITY, THERE WAS RESISTANCE DURING DELIVERY OF EVERY PIPELINE USED IN THE PROCEDURE. ALL THE PIPELINES EITHER DELIVERED OR ATTEMPTED TO BE DELIVERED AS NOTED WITHIN THE REPORT SHOWED SIGNS OF DAMAGE AND ¿KINKING¿ DUE TO THE USE OF THE OFF-LABEL HEMOSTAT. THE PHYSICIAN WAS AWARE THE ISSUE WAS NOT WITH THE PIPELINES BUT DUE THE TO SEVERE TORTUOSITY OF THE ICA AND RADIAL ACCESS APPROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426365 ↗
• MalfunctionDec 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE MARKSMAN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY CAVERNOUS S EGMENT WITH A MAX DIAMETER OF 25MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE MARKSMAN MICROCATHETER WAS IN PLACE, AND THEN THE PIPELINE STENT WAS PUSHED. HOWEVER, IT WAS DIFFICULT TO PUSH THE PIPELINE THROUGH THE MIDDLE AND DISTAL SEGMENTS, AND IT COULD NOT BE DEPLOYED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE OR THE CATHETER. AFTER REPLACING THE PIPELINE, THE SURGERY WAS COMPLETED SMOOTHLY. 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 BLOOD FLOW IN THE PARENT ARTERY WAS SMOOTH, AND THE BLOOD FLOW IN THE ANEURYSM WAS SLOWLY DEPOSITED. ANCILLARY DEVICES INCLUDE A 6FNAVIEN 115, MARKSMAN 150.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016055 ↗
• MalfunctionDec 4, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN NOTED THAT THERE WAS NO DAMAGE SEEN ON THE DEVICES, AND THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943264 ↗
• MalfunctionSep 8, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS WITH A MAX DIAMETER OF 23 .29MM AND A 7.89MM 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 AFTER THE PIPELINE FLEX REACHED THE PREDETERMINED POSITION WITH THE MARKSMAN MICROCRATER, THE PIPELINE COULD NOT BE OPENED DURING THE PROCESS OF RETRACTING THE MICROCATHETER. THE INSTRUCTIONS IN THE OPERATION GUIDE WERE FOLLOWED TO DEPLOY AND WAIT MORE THAN TEN MINUTES, THEN THE PIPELINE WAS RETRIEVED AND DEPLOYED TWO TIMES. THE DISTAL END OF THE PIPELINE STILL COULD NOT OPEN. IT WAS STATED THE DEVICE WAS NOT POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, RESHEATHING WAS DONE MORE THAN 2 TIMES, AND NO ADDITIONAL STEPS OR DEVICES WERE USED TO TRY AND OPEN THE PIPELINE. THE MARKSMAN AND PIPELINE WERE THEN REMOVED TOGETHER FROM THE PATIENT. REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUC

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

  MAUDE report 10504931 ↗
• DeathAug 5, 2020Break; Activation Failure; Physical Resistance/Sticking; Break; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN, THE PUSHWIRE BROKE AT THE HYPOTUBE, AND THE PATIENT EXPERIENCED COMPLICATIONS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT ANTERIOR CHROIDAL WITH A MAX DIAMETER OF 30MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THE DEVICE WAS PLACED WELL DISTALLY, AS THE DOCTOR WAS DEPLOYING AROUND THE BEND OF THE MCA ORIGIN/ICA TERMINUS, THE DEVICE BEGAN TO RIBBON OR FLATTEN AND THERE WAS FRICTION. THE DISTAL AND MIDDLE SEGMENTS OF THE DEVICE FAILED TO OPEN AND WERE POSITIONED IN THE BEND. THE PHYSICIAN TRIED A FEW TECHNIQUES TO OPEN THE DEVICE: WAITED 60 SECONDS, REDUCED LOAD, WAGGING, AND RESHEATH JUST OVER THE POINT OF THE DEVICE THAT WAS FLATTENED. NOTHING RESOLVED THE ISSUE, SO THE PHYSICIAN CONTINUED DEPLOYING AND PUSHED MORE WIRE. WHEN TRYING TO REDUCE THE LOAD AGAIN BY PULLING BACK THE DEVICE AND MICROCATHETER TOGETHER, IT WAS REALIZED THE PUSHWIRE WAS NO LONGER ATTACHED. THE PUSHWIRE HAD BROKEN AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. THE MICROCATHETER WAS UNSHEATHED PAST THE RESHEATHING MARKER, AND THE DEVICE WAS NOT OPEN PROXI

  Patient problems: Death; Device Embedded In Tissue or Plaque; Hemorrhage/Blood Loss/Bleeding; Infarction, Cerebral; Paraplegia

  MAUDE report 10367676 ↗
• MalfunctionJan 23, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PROXIMAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED, LEFT ANEURYSM WITH A MAX DIAMETER OF 7MM AND A 20MM NECK DIAMETER, AND A LANDING ZONE OF 3.75X3.5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST TWO OF THREE PIPELINES WERE WELL EXPANDED WHEN RELEASING THE STENT, BUT THE LAST PIPELINE WAS KINKED AND THE PROXIMAL SECTION COULD NOT OPEN. THE PIPELINE WAS NOT POSITIONED IN A BEND, MORE THAN 50% WAS DEPLOYED WHEN IT FAILED TO OPEN, IT WAS RE-SHEATHED MORE THAN TWO TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED TO TRY AND OPEN THE PIPELINE. AFTER SEVERAL ATTEMPTS TO DRAG IT, THE STENT WAS OPENED. HOWEVER, THE STENT WAS WARPED, AND THE PHYSICIAN CONSIDERED THAT THE SHAPE MAY INFLUENCE THE ABILITY TO ATTACH TO THE VESSEL WALL. THE PIPELINE WAS RETRIEVED AND WITHDRAWN FROM THE PATIENT'S BODY, AND A NEW 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. ANCILLARY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9621704 ↗
• MalfunctionNov 21, 2019Break; Break

  IT WAS REPORTED THE PIPELINE WAS SUCCESSFULLY DEPLOYED IN THE INTENDED REGION. UPON RECAPTURE OF THE DISTAL COIL TIP, THE PUSHER WIRE FRACTURED FROM THE PROXIMAL BUMPER. IT WAS INDICATED THAT THE PUSHER WIRE DETACHED AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. NO FRICTION OR DIFFICULTY WAS ENCOUNTERED. ALL SEGMENTS OF THE PUSHER WIRE AND DELIVERY SECTION OF THE DEVICE WAS REMOVED WITH THE MICROCATHETER. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF APPROXIMATELY 20MM AND A NECK DIAMETER OF APPROXIMATELY 6MM. THE DISTAL LANDING ZONE WAS 3.7MM, AND THE PROXIMAL LANDING ZONE WAS 4.6MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355499 ↗
• MalfunctionJul 10, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE TIP OF TWO PIPELINES WERE NOT OPENING. PRIOR TO THE EVENT, THE MARKSMAN WAS POSITIONED INTO PLACE AND THE IT WAS ADJUSTED AND RIVETED AND WITHDRAWN TO DEPLOY THE PIPELINE AND THE REPORTED EVENT OCCURRED. THE PHYSICIAN REPEATEDLY ADJUSTED THE DEVICE; HOWEVER, THE TIP STILL WOULD NOT OPEN. THE PIPELINE WAS REPLACED BY ANOTHER PIPELINE AND NEW MARKSMAN AND THE SAME EVENT OCCURRED. CONSIDERING THE PATIENT¿S TORTUOUS VASCULATURE AND LONG DURATION OF THE PROCEDURE, THE OPERATION WAS COMPLETED. IT WAS NOT KNOWN HOW. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED AMORPHOUS ANEURYSM MEASURING 20MM X 12MM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 4.0MM X 4.2MM. THAT VASCULATURE WAS SEVERE IN TORTUOSITY. THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE MARKSMAN WAS WITHDRAWN AND REPEATEDLY ADJUSTED BUT THE ISSUE PERSISTED. ANCILLARY DEVICES: MARKSMAN 150, COOK 7F LONG SHEATH GUIDE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777481 ↗
• MalfunctionJul 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PIPELINE WAS RELEASED, THE DISTAL/MIDDLE END WAS KINKED, CAUSING A FAILURE TO OPEN. AFTER REPEATED ATTEMPTS THE DEVICE COULD NOT BE RELEASED AS NORMAL, SO IT WAS REPLACED. ONCE THE MICROCATHETER WAS WITHDRAWN, A PUSH-PULLWRINKLE AT THE DISTAL COIL SECTION WAS SEEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR LEFT ICA ANEURYSM WITH A MAX DIAMETER OF 34.4MM AND A NECK DIAMETER OF 13MM. POST PROCEDURE ANGIOGRAPHIC RESULTS WERE NORMAL. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MINIMAL. THERE WERE NO RELATED PATIENT SYMPTOMS. LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE DEVICES WERE PREPARED/FLUSHED AS INDICATED PER THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8765168 ↗
• MalfunctionMar 23, 2017Physical Resistance; Activation Failure; Physical Resistance; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE CEREBRAL ANEURYSM, SIZE: 18MM / FLOW DIVERSION PROCEDURE, THE PHYSICIAN DELIVERED THE FLOW DIVERTER THROUGH THE MICROCATHETER, AND TRIED TO OPEN THE FLOW DIVERTER. HOWEVER, THE TIP OF THE FLOW DIVERTER DID NOT OPEN. THE FLOW DIVERTER WAS ALSO REPORTED TO HAVE BECOME STUCK AND ONLY 10MM TO 15MM OF THE FLOW DIVERTER WAS DEPLOYED FROM THE MICROCATHETER, AND THE REST COULD NOT BE PUSH OUT. NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THE ANATOMY WAS SLIGHTLY SEVERE AND THE VESSEL WAS MEDIUM IN SIZE DIAMETER. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6429551 ↗

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-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