PIPELINE PED-500-20 (UDI 00847536019720)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00847536019720), received between Mar 27, 2017 and Mar 17, 2022 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (28 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR, IRREGULAR ANEURYSM LOCATED IN THE OCULAR SEGMENT OF THE LEFT CAROTID ARTERY WITH ASCUS. THE MAX DIAMETER WAS 3.56MM, AND THE NECK DIAMETER WAS 5.07MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 5.16MM DISTAL AND 4.26MM PROXIMAL. IT WAS REPORTED THAT PIPELINE WAS DEPLOYED AT M2. DUE TO THE LARGE CHANGE IN BLOOD VESSELS, THE STENT COULD NOT BE OPENED. THE PIPELINE WAS MASSAGED WITH THE WIRES, BUT IT STILL COULD NOT BE OPENED. THE PIPELINE WAS NOT POSITIONED IN A BEND, AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. IT WAS REPORTED THAT THE PROXIMAL, MIDDLE, AND DISTAL SEGMENTS OF THE DEVICE FAILED TO OPEN. THE PIPELINE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED RETENTION IN THE ANEURYSM, AND BLOOD FLOW WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NEURON MAX 6F GUIDE CATHETER AND A MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795012 ↗
• MalfunctionDec 19, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. REPEATED RECOVERY WAS ATTEMPTED, INCREASED OR DECREASED TENSION DURING OPERATION TO TRY TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040608 ↗
• MalfunctionNov 7, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE STENT WAS DEPLOYED IN THE MIDDLE CEREBRAL ARTERY M1, THE DISTAL END COULD NOT BE OPENED. IT WAS RETRIEVED ONCE AND IT COULD NOT BE OPENED AFTER BEING DEPLOYED AGAIN, RESULTING IN THE FAILURE OF ANCHORING THE DISTAL END OF THE STENT. IT WAS SUSPECTED THAT THE PRODUCT WAS DEFECTIVE. THE PIPELINE WAS NOT POSITIONED IN A BEND. IT WAS UNKNOWN HOW MUCH OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NOT ADDITIONAL STEPS OR DEVICES REQUIRED TO OPEN THE PIPELINE. IT WAS UNKNOWN IF THE PIPELINE HAD BEEN REMOVED FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN IF A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED INTRACRANIAL ANEURYSM. THE PIPELINE WAS NOT USED FOR AN INDICATED NOT APPROVED AND THE DEVICES WERE ALL PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A AMORPHOUS, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4.1MM AND A 2MM NECK DIA METER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12764364 ↗
• MalfunctionJul 29, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FAILED TO OPEN AT THE DISTAL SECTION. AFTER REPEATED RECYCLING WITH MARKSMAN, IT WAS FOUND THAT THE TIP END OF THE STENT WAS ROUGH. THE DEVICE WAS BEING USED TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT OPHTHALMIC ARTERY SEGMENT. THE ANEURYSM HAD A MAX DIAMETER OF 16 MM AND A NECK DIAMETER OF 6 MM. THE DISTAL LANDING ZONE WAS 4.0 MM AND THE PROXIMAL LANDING ZONE WAS 5.0 MM. VESSEL TORTUOSITY WAS MODERATE. ACCESS VESSEL WAS THE FEMORAL ARTERY.  DURING THE DEPLOYMENT PROCESS OF THE 5.0-20 PIPELINE, AFTER REPEATED ATTEMPTS, THE TIP END WAS ALWAYS TAPERED AND COULD NOT BE FULLY OPENED. AFTER REPEATED RECYCLING WITH MARKSMAN, IT WAS FOUND THAT THE TIP END OF THE STENT WAS ROUGH. IT WAS PLANNED TO REPLACE PIPELINE AND RELOCATE THE WHOLE SYSTEM. IN ORDER TO ENSURE THE SUCCESSFUL PLACEMENT OF THE NEW PIPELINE, REPLACED WITH THE NEW CATHETER. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINES 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 WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246708 ↗
• 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 12160007 ↗
• 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 ANEURYSMWITH 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 12036050 ↗
• 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 12036023 ↗
• MalfunctionJun 11, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PIPELINE WAS DEPLOYED, THE DISTAL END COULD NOT BE OPENED. AFTER REPEATED ADJUSTMENTS, THERE WERE STILL PROBLEMS. RE-SHEATHING HAD BEEN PERFORMED LESS THAN THREE TIMES, THE STENT HAD NOT BEEN POSITIONED IN A BEND, LESS THAN 50% OF THE STENT HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, AND NO ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE STENT. AFTER REMOVAL, IT WAS FOUND THE STENT WAS SERIOUSLY DAMAGED. A REPLACEMENT PRODUCT 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. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED OBVIOUS RETENTION IN THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM  OF THE INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 9 MM AND A 6.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) HAD BEEN ADMINISTERED. ANCILLARY DEVICES INCLUDE A 6F LONG SHEATH, NAVIEN 5F 115, MARKSMAN 150.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982301 ↗
• MalfunctionJun 4, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PIPELINE WAS DELIVERED, THE DISTAL SEGMENT OF THE STENT COULD NOT BE OPENED. THE OPERATING INSTRUCTIONS WERE FOLLOWED TO DEPLOY, AND IT WAS WITHDRAWN AFTER WAITING MORE THAN 10 MINUTES. ANOTHER ATTEMPT TO DEPLOY WAS MADE, BUT THE STENT STILL COULD NOT BE OPENED. IT WAS NOTED THE PIPELINE WAS NOT POSITIONED IN A BEND, MORE THAN 50% OF THE STENT HAD BEEN DEPLOYED, RESHEATHING WAS PERFORMED MORE THAN TWICE, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED TO OPEN THE PIPELINE. THE PIPELINE AND CATHETER WERE WITHDRAWN 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 THE EFFECT OF THE BLOOD FLOW GUIDANCE WAS SATISFACTORY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE END OF THE INNER LEFT NECK WITH A MAX DIA METER OF 7.39 MM AND A 4.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938157 ↗
• MalfunctionMay 25, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN AFTER MANY ATTEMPTS. THE STENT WAS NOT POSITIONED IN A BEND, AND NO ADDITIONAL STEPS OR DEVICES WERE USED IN AN ATTEMPT TO OPEN THE PIPELINE. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878587 ↗
• MalfunctionApr 8, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633380 ↗
• MalfunctionJan 19, 2021Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194388 ↗
• MalfunctionDec 8, 2020Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971679 ↗
• MalfunctionOct 26, 2020Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MARKSMAN AND PIPELINE (PED-500-20) WERE IN PLACE, THE SURGEON STARTED TO DEPLOY THE STENT. HOWEVER, A LARGE RESISTANCE WAS FELT, AND THE PIPELINE COULD NOT BE PUSHED OUT OF THE MICROCATHETER. AFTER REPEATED ADJUSTMENTS, IT STILL COULD NOT BE PUSHED. IT WAS ALSO REPORTED THE DISTAL END OF THE PIPELINE FAILED TO OPEN ONCE IT WAS ABLE TO BE PUSHED PAST THE RESISTANCE. THE MARKSMAN AND PIPELINE WERE REMOVED TOGETHER, AND IT WAS FOUND THE STENT'S TIP AND TAIL WERE FOUND TO BE THE SHAPE OF A FISH'S MOUTH. NEW PRODUCTS WERE THEN USED TO COMPLETE THE PROCEDURE WITH NO ISSUE. POST-PROCEDURE ANGIOGRAPHY SHOWED NORMAL RESULTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY CAVERNOUS SEGMENT WITH A MAX DIAMETER OF 10 MM AND A 6 MM NECK DIAMETER. 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. ANCILLARY DEVICES INCLUDE A 6F 115NAVIEN, AND MARKSMAN MICROCATHETER.

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

  MAUDE report 10733353 ↗
• MalfunctionOct 16, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, AND WAS IN THE RELATIVELY STRAIGHT SECTION OF M1. THE DIAMETER OF THE M1 BLOOD VESSEL WAS THIN, ABOUT 3 MM. ADDITIONAL STEPS TAKEN TO OPEN THE PIPELINE INCLUDED TRYING TO RETRIEVE AND DEPLOY IT IN THE NAVIEN CATHETER.

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

  MAUDE report 10691300 ↗
• MalfunctionSep 17, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A RESISTANCE BETWEEN A PIPELINE DEVICE IN A MARKSMAN CATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF A SEGMENT OF AN OPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 18.9MM AND THE NECK DIAMETER WAS 9.2MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE COULDNOT BE PUSHED OUT OF THE MARKSMAN CATHETER. THE DEVICES HAD BEEN PREPARED AND USED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER IFU. THE DEVICES WERE REPLACED TO CONTINUE TO THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10545152 ↗
• MalfunctionSep 16, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS RESISTANCE IN THE DISTAL PART OF THE CATHETER.

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

  MAUDE report 10541400 ↗
• MalfunctionAug 24, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT POST DEPLOYMENT OF THE PIPELINE THE PHENOM 27 WAS ADVANCED TO RETRIEVE THE TIP COIL. WHEN IT REACHED THE TIP COIL TO RECAPTURE, IT ADVANCED PASSED THE TIP COIL. A SECOND PASS WAS MADE AND MISSED IT AGAIN, WE THEN CONCLUDED THAT THE TIP COIL HAD BROKEN OFF FROM THE DELIVERY WIRE. A SNARE DEVICE WAS USED TO RETRIEVE THE TIP COIL AND PLACED A SECOND DEVICE. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT USED OFF-LABEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. NO IMAGES ARE AVAILABLE. THE PATIENT WAS TREATED FOR A LEFT INTERNAL CAROTID ARTERY (ICA), UNRUPTURED, FUSIFORM ANEURYSM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

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

  MAUDE report 10442797 ↗
• MalfunctionJul 22, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE DEVICES WERE PREPARED AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSH OF THE CATHETER WAS PROVIDED. THERE WAS NO RESISTANCE DURING PIPELINE DELIVERY BUT IT WAS STUCK IN THE PROXIMAL END OF THE CATHETER DURING RETRIEVAL. BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307516 ↗
• MalfunctionMay 29, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THERE WAS NO VISIBLE DAMAGE TO THE DEVICES OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10101402 ↗
• MalfunctionDec 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THE PIPELINE FLEX DID NOT OPEN. THE PIPELINE WAS ADJUSTED 3 TIMES BUT STILL DID NOT OPEN NORMALLY. THE DEVICE WAS REPLACED WITH ANOTHER PIPELINE. NO PATIENT INJURY OCCURRED. THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED, LEFT OPHTHALMIC ARTERY SEGMENT, SACCULAR ANEURYSM. THE MAX AND THE NECK DIAMETERS WERE 5MM EACH. THE DISTAL LANDING ZONE WAS 4.9MM AND THE PROXIMAL WAS 5MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9417467 ↗
• MalfunctionNov 17, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL END. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW DEVICES WITH GOOD RESULTS. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR AN UNRUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9333622 ↗
• MalfunctionAug 23, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE PIPELINE FLEX WITH SHIELD EMBOLIZATION, THE PIPELINE WAS DELIVERED INTO THE INTENDED LOCATION, BUT THE PROXIMAL SECTION FAILED TO OPEN. THE DEVICE WAS NOT PLACED IN A BEND. LESS THAN 50% OF THE DEVICES HAD BEEN DEPLOYED WHEN THE EVENT OCCURRED. THE DEVICE WAS RESHEATED LESS THAN OR EQUAL THAN 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THE DEVICE WAS REMOVED WITH THE CATHETER. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS TREATED FOR AN ANEURYSM CYSTIC, LOCATED IN THE LEFT OCULAR ARTERY SEGMENT. THE ANEURYSM WAS UNRUPTURED, SACCULAR WITH A MAX DIAMETER OF 12 MM AND A NECK DIAMETER OF 5 MM. THE DISTAL LANDING ZONE WAS 4.6 MM AND THE PROXIMAL WAS 5.1 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925392 ↗
• MalfunctionJun 27, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DEVICE DID NOT OPEN IN THE DISTAL. THE PIPELINE WAS REMOVED AND ANOTHER DEVICE (SAME SIZE) WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY ANEURYSM LOCATED IN OPHTHALMIC SECTION, MEASURING 20MMX6MM, LANDING ZONE DISTAL 4.4MM PROXIMAL 4.7MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SEMI-HEMISPHERIC FILLING OF CONTRAST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739868 ↗
• MalfunctionApr 10, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX DID NOT OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM IN THE LEFT ICA, IT WAS UNRUPTURED AND SACCULAR. THE LANDING ZONE WAS 4MM DISTALLY AND 4.5MM PROXIMAL. NO PATIENT INJURY OCCURRED. THE ANATOMY WAS REPORTED TO BE MODERATE IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE PIPELINE FLEX HAD HIGH RESISTANCE WHEN ADVANCING. THE PIPELINE FLEX WAS DEPLOYED AND REPORTEDLY DID NOT OPEN CORRECTLY AT THE DISTAL END. RESHEATHING WAS UNSUCCESSFUL. THEREFORE, THE DEVICES WERE REMOVED AS A UNIT. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501957 ↗

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