PIPELINE PED-500-16 (UDI 00847536019669)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00847536019669), received between Mar 13, 2017 and Feb 3, 2022 — classified as 2 deaths, 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (24 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443142 ↗
• MalfunctionOct 7, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES WOULD NOT OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID SUPERCLINOID ARTERY WITH A MAX DIAMETER OF 8MM AND A 2MM NECK DIAMETER. THE LANDING ZONE DIAMETER WAS 3.74MM ON THE DISTAL END AND 5.1MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS ADMINISTERED. ANGIOGRAPHIC RESULTS WERE THE SAME AS PRE-PROCEDURE. MEDICAL HISTORY INCLUDED LUNG CANCER ( 1 YR CLEAR), AND DIVERTICULITIS. IT WAS REPORTED THAT THE PIPELINE WOULD NOT OPEN DISTALLY. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT WAS RESHEATHED MORE THAN 2 TIMES. ADDITIONAL STEPS INCLUDED MULTIPLE MANIPULATIONS, RECAPTURE, WAGGING, AND PULLING THE DEVICE BACK. THE PIPELINE WAS RESHAETHED AND REMOVED WITH THE MICROCATHETER. THE DOCTOR IS AN EXPERIENCED PIPELINE USER. THIS WAS TORTUOUS ANATOMY. THIS HAPPENED THREE TIMES WHERE THE PIPELINES FAILED TO OPEN AT ALL DISTALLY. THE DOCTOR ABORTED THE PROCEDURE. THE PIPELINE WAS NOT USED F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12592219 ↗
• MalfunctionSep 15, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR OPHTHALMIC ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 5MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PHENOM27 MICROCATHETER WAS IN PLACE AND THE PIPELINE WAS DELIVERED. HOWEVER, THE DISTAL TIP OF THE PIPELINE COULD NOT BE OPENED AFTER MORE THAN 50% OF THE PIPELINE WAS DEPLOYED. THE MIDDLE SECTION OF THE PIPELINE WAS POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. THE PIPELINE STILL COULD NOT BE OPENED AFTER REPEATED PUSHING, PULLING, AND SWINGING. FINALLY THE PIPELINE WAS RESHEATHED AND REMOVED TOGETHER WITH THE PHENOM MICROCATHETER. BURRS WERE OBSERVED ON THE TIP OF THE PIPELINE WITH THROMBUS ADHESION OBSERVED. BOTH DEVICES WERE REPLACED AND THE NEW PIPELINE WAS SUCCESSFULLY IMPLANTED.  THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. POST-PROCEDURE ANGIOGRAPHY SHOED SLOWED FLOW TO THE ANEURYSM AND THAT THE PATIENT BLOOD VESSELS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474530 ↗
• MalfunctionJul 13, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159963 ↗
• MalfunctionJul 2, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE STENT COULD NOT BE OPENED. THE DEVICE WAS NOT POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED AT THE TIME, RESHEATHING WAS PERFORMED MORE THAN TWICE, AND NO ADDITIONAL DEVICES OR STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. THE STENT AND MICROCATHETER WERE REMOVED TOGETHER, AND 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 SHOWED SLOWED DOWN BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL REACHED STANDARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109021 ↗
• InjuryJun 21, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 3 PIPELINE DEVICES WERE LAZY TO OPEN IN THE MIDDLE AND DISTAL SEGMENTS AND WERE RECAPTURE MULTIPLE TIMES WHICH DID NOT RESOLVE THE ISSUE. THE DEVICES WERE REMOVED AND SUBSEQUENT DEVICES USED. THE FOURTH DEVICE WAS USED SUCCESSFULLY BUT WAS ALSO A BIT LAZY TO OPEN, AND THE PROXIMAL END WAS NOT COMPLETELY OPPOSED. AFTER MULTIPLE ATTEMPTS TO CROSS INTO THE DEVICE, IT WAS FOUND THAT A SMALL FISTULA HAD FORMED, SO ANOTHER PIPELINE WAS USED TO COVER THE FISTULA WHICH WAS IMPLANTED SUCCESSFULLY AND PROVIDED A SATISFACTORY RESULT. THE PATIENT WAS UNDERGOING AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 6MM AND A NECK WIDTH OF 4MM. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU AND THE PATIENT'S VESSEL TORTUOSITY WAS NOTED TO BE SEVERE. THE DEVICES WERE PLACED IN A BEND IN THE MIDDLE SECTION DURING DEPLOYMENT. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THE PRU LEVEL WAS UNKNOWN. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED PARTIAL FILLING OF THE ANEURYSM.

  Patient problems: Fistula

  MAUDE report 12036192 ↗
• MalfunctionJun 3, 2021Break; Unintended Ejection; Break; Unintended Ejection

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN DID NOT RECALL ROTATING OR PULLING ON THE PUSHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935211 ↗
• MalfunctionApr 9, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE DISTAL PART OF THE CATHETER, AND IN ONE OF THE INSTANCES, THE PIPELINE BECAME DETACHED FROM THE PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645981 ↗
• MalfunctionApr 9, 2021Break; Unintended Ejection; Material Deformation; Activation Failure; Physical Resistance/Sticking; Break; Unintended Ejection; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PIPELINE DETACHED FROM THE PUSHWIRE PREMATURELY, AND THERE WAS NO DAMAGE NOTED TO THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645970 ↗
• MalfunctionApr 6, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HAD BEEN RESHEATHED, BUT NO ADDITIONAL DEVICES WERE USED TO ATTEMPT TO OPEN THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625593 ↗
• MalfunctionNov 23, 2020Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10885637 ↗
• MalfunctionOct 4, 2020Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

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

  MAUDE report 10624661 ↗
• DeathSep 14, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN, BUT THE SECOND ONE WAS OPENED WITH BALLOON ANGIOPLASTY. THE PATIENT EXPERIENCED EXTRAVASATION IN THE SUBARACHNOID SPACE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT CAVERNOUS INTERNAL CAROTID ARTERY PA RA-OPHTHALMIC SEGMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE 5X16 PIPELINE (PLI-10) WAS ATTEMPTED TO BE DEPLOYED, BUT IT FAILED TO OPEN IN THE MIDDLE SEGMENT. THE FIRST PIPELINE WAS REMOVED, AND A REPLACEMENT (PLI-20) SIZE WAS CHOSEN OF 5X20, BUT THE PIPELINE WAS DEEMED TOO LONG. THE SECOND PIPELINE WAS REMOVED, AND A THIRD PIPELINE (PLI-30) OF 5X16 WAS DELIVERED. THE DISTAL END OF THE THIRD PIPELINE FAILED TO OPEN. IT WAS NOTED THE DEVICE WAS NOT POSITIONED IN A BEND, MORE THAN 50% OF THE PIPELINES WERE DEPLOYED WHEN THEY FAILED TO OPEN, AND THE THIRD PIPELINE WAS RESHEATHED LESS THAN THREE TIMES. A BALLOON WAS INSERTED ACROSS THE PIPELINE AND INFLATED. NO CONTRAST WAS VISUALIZED IN THE BALLOON, AND FULL WALL APPOSITIO

  Patient problems: Death; Discomfort; Hemorrhage, Subarachnoid

  MAUDE report 10532930 ↗
• DeathSep 14, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN, BUT THE SECOND ONE WAS OPENED WITH BALLOON ANGIOPLASTY. THE PATIENT EXPERIENCED EXTRAVASATION IN THE SUBARACHNOID SPACE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT CAVERNOUS INTERNAL CAROTID ARTERY PA RA-OPHTHALMIC SEGMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE 5X16 PIPELINE (PLI-10) WAS ATTEMPTED TO BE DEPLOYED, BUT IT FAILED TO OPEN IN THE MIDDLE SEGMENT. THE FIRST PIPELINE WAS REMOVED, AND A REPLACEMENT (PLI-20) SIZE WAS CHOSEN OF 5X20, BUT THE PIPELINE WAS DEEMED TOO LONG. THE SECOND PIPELINE WAS REMOVED, AND A THIRD PIPELINE (PLI-30) OF 5X16 WAS DELIVERED. THE DISTAL END OF THE THIRD PIPELINE FAILED TO OPEN. IT WAS NOTED THE DEVICE WAS NOT POSITIONED IN A BEND, MORE THAN 50% OF THE PIPELINES WERE DEPLOYED WHEN THEY FAILED TO OPEN, AND THE THIRD PIPELINE WAS RESHEATHED LESS THAN THREE TIMES. A BALLOON WAS INSERTED ACROSS THE PIPELINE AND INFLATED. NO CONTRAST WAS VISUALIZED IN THE BALLOON, AND FULL WALL APPOSITIO

  Patient problems: Death; Discomfort; Hemorrhage, Subarachnoid

  MAUDE report 10532926 ↗
• MalfunctionAug 17, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FAILED TO OPEN. THE DEVICE WAS RESHEATH MANY TIME IN THE ATTEMPT TO OPEN THE BRAID, HOWEVER, ALL ATTEMPTS FAILED TO OPEN THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN TRIED MULTIPLE TIME TO GET THE DISTAL END TO OPEN AND FINALLY WAS ABLE TO GET IT AND CONTINUED DEPLOYMENT AND DID NOT TRUST THE BEHAVIOR OF THE MID PORTION OF THE DEVICE WAS GOING TO OPEN AND AFTER MULTIPLE MANIPULATION HE DECIDED TO PULL THE MEDTRONIC AND PIPELINE OUT AND WENT WITH A 4.75 DEVICE THAT WORKED PERFECT. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTION FOR USE (IFU). A CONTINUOUS FLUSH USED DURING ADVANCEMENT OF THE PED. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT WITH FLOW DIVERTER FOR A RIGHT OPHTHALMIC ANEURYSM WITH MODERATE TORTUOUS ANATOMY. NO PATIENT INJURY OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10417992 ↗
• MalfunctionAug 12, 2020Activation Failure; Activation Failure

  THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTION FOR USE (IFU). A CONTINUOUS FLUSH USED DURING ADVANCEMENT OF THE PED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10397870 ↗
• MalfunctionApr 30, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION: THE PIPELINE WAS NOT PLACED IN A BEND. THE DEVICE WAS DEPLOYED IN THE M1 AND IT DID OPEN. MULTIPLE RESHEATHING ATTEMPTS WERE MADE TO EXPAND THE DEVICE. THE TREATING LOCATION WAS A LEFT PARAOPHTHALMIC ANEURYSM, 6 MM. THE VESSEL ANATOMY WAS NORMAL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10013186 ↗
• MalfunctionApr 23, 2020Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX DEVICES FAILED TO OPEN. IT WAS REPORTED THAT THE DEVICE WAS PLACED IN LEFT M1, PARTIALLY DEPLOYED AND DRAGGED BACK INTO POSITION. THE DISTAL HALF OPENED CORRECTLY AND THEN KINKED IN THE TURN. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT THE MIDDLE SECTION FAILED TO OPEN. IT WAS RESHEATHED MORE THAN TWO TIMES AND THE KINK WOULDN¿T COME OUT. ANOTHER PIPELINE EXPERIENCED THE SAME ISSUE, AND THEY WERE REMOVED WITH THE MICROCATHETER. THE DEVICES WERE NOT REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE PARAOPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 5 MM AND THE NECK WAS 4.5 MM. THE LANDING ZONE OF THE ARTERY WAS NOTED TO BE 4.89 MM DISTAL AND 5.1 MM PROXIMAL. THE VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AT A 120 PRU LEVEL. THE PIPELINE AND ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993329 ↗
• InjuryApr 22, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SECOND PIPELINE AND THE PHENOM CATHETER HAD BEEN DISCARDED. THERE WAS NOT ANOTHER EPISODE OF EMBOLISM, AND POST-PROCEDURE, THE PATIENT WAS GIVEN INTEGRILIN. AS OF 2020-05-15, THE PHYSICIAN REPORTED THE PATIENT WAS DOING WELL AND HOME.

  Patient problems: Embolus

  MAUDE report 9988318 ↗
• MalfunctionOct 30, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX DID NOT OPEN AT THE PROXIMAL PORTION OF THE STENT. THE DEVICE WAS RESHEATHED 3 TIMES. THE ICA WAS TORTUOUS IN VESSEL ANATOMY. A CONTINUOUS FLUSH WAS USED. NO PATIENT DEMOGRAPHY PROVIDED. THE DEVICE WAS REMOVED, AND A SMALLER SIZE PIPELINE DEVICE WAS USED TO TREAT THE PATIENT. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257010 ↗
• MalfunctionSep 27, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX DISTAL TIP FAILED TO OPEN. THE DEVICE WAS REMOVED THE PATIENT WAS TREATED WITH A STENT. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED THE TREATMENT OF A LEFT INTERNAL CAROTID ARTERY ANEURYSM, THAT WAS UNRUPTURED. THE MAX DIAMETER WAS 10.1MM AND THE NECK WAS 5.1MM. THE DISTAL LANDING ZONE WAS 4.7MM AND THE PROXIMAL WAS 5.1MM. THE ANATOMY WAS MINIMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9127921 ↗
• MalfunctionDec 4, 2018Break; Material Deformation; Activation Failure; Break; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THROUGH MEDWATCH THAT DISTAL END OF THE PIPELINE LOOKED RAGGED AND WOULD NOT OPEN. WHEN TRYING TO REMOVE IT BROKE OFF IN THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129016 ↗
• MalfunctionNov 27, 2018Material Deformation; Activation Failure; Material Deformation; Activation Failure

  THE PED WAS USED WITH A MEDTRONIC CATHETER. IT IS UNKNOWN IF THERE WAS A CONTINUOUS FLUSH USED. THE PATIENT WAS TREATED FOR LEFT SUPERIOR HYPOPHYSEAL ARTERY ANEURYSM. A NEW DEVICE WAS USED TO TREAT THE PATIENT. MEDWATCH # 4900320000-2018-8041.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107580 ↗
• MalfunctionNov 8, 2018Mechanical Problem; Material Deformation

  ONCE THE DEVICE WAS IN THE PATIENT, THE DISTAL END OF THE STENT LOOKED RAGGED AND WOULD NOT OPEN UNDER FLUOROSCOPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050588 ↗
• MalfunctionNov 8, 2018Break; Material Deformation

  DISTAL END OF THE STENT LOOKED RAGGED AND WOULD NOT OPEN. WHEN TRYING TO REMOVE IT, BROKE OFF IN THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050587 ↗

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