PIPELINE PED-500-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00847536019782), received between Aug 13, 2018 and May 7, 2022 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE TIP OF THE PIPELINE HEAD WAS DEPLOYED ABOUT 5MM, ANCHORING POSITION WAS NOT IDEAL. RECOVERED TO THE MICROCATHETER ACCORDING TO STANDARD STEPS. WHEN RE-DEPLOYED, IT WAS FOUND THAT THE TIP COULD NOT BE OPENED WELL. AFTER WITHDREW TO VITRO, THE TIP WAS FOUND TO BE ROUGH. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE PIPELINE WAS USED FOR AN INDICATION THAT WAS APPROVED, THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 10.3MM AND A 5.2MM NECK DIAMETER. LANDING ZONE WAS 4.23MM DISTAL AND 4.98MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSELTORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315870 ↗
• MalfunctionNov 23, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DISTAL AND PROXIMAL ENDS FAILED TO OPEN. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU AND WAS NOT USED OFF-LABEL. THE MIDDLE SECTION OF THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO FURTHER STEPS TAKEN TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS 67. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED STAGNATION IN THE ANEURYSM AND THE PARENT VESSEL OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT CAVERNOUS WITH A MAX DIAMETER OF 11MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: NEURON MAX SHEATH, PHENOM PLUS GUIDE CATHETER, AND A PHENOM 27 150CM MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866487 ↗
• MalfunctionSep 8, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE HAD FAILURE TO OPEN AND THERE WAS CATHETER RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 17.21MM AND A 8.99MM NECK DIAMETER. THE LANDING ZONE WAS 4.1MM AND THE PROXIMAL WAS 5.03MM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6MM. THE TREATMENT WAS DENSE MESH STENT IMPLANTATION FOR INTRACRANIAL ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) ADMINISTERED, AA 71%, ADP 81%. ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE AORTIC ANEURYSM OF RIGHT CAVERNOUS SINUS WAS PLANNED TO BE TREATED WITH DENSE MESH STENT IMPLANTATION. AT FIRST, PHENOM 27 WAS SUCCESSFULLY PLACED IN THE MIDDLE CEREBRAL ARTERY M2. ALTHOUGH THE PIPELINE STENT DELIVERY HAD RESISTANCE IN THE DISTAL END, IT WAS SMOOTHLY PUSHED TO THE DISTAL END AND OPENED IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PHENOM STENT CATHETER WAS WITHDRAWN. THE PIPELINE STENT WAS EXPOSED BUT THE TIP COULD NOT BE OPENED. IT WAS DEPLOYED FOR A LONGER DISTANCE OF ABOUT 13MM. AFTER WAITING,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439620 ↗
• MalfunctionAug 4, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE HAD RESISTANCE IN THE CATHETER AT THE DISTAL SECTION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS OPHTHALMIC ARTERY ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY, MULTIPLE ANEURYSMS. THE MAX DIAMETER WAS 10MM, AND THE NECK DIAMETER WAS 10MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.3MM DISTAL AND 4.9MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 6MM IN DIAMETER. AFTER THE MARKSMAN WAS IN PLACE AND WAS USED IN THE SURGERY, THE PED-500-30 STENT WAS SELECTED AND DELIVERED TO THE DISTAL END THROUGH THE CATHETER, AND THE MICROCATHETER WAS WITHDRAWN. THE HEAD END OF THE STENT COULD NOT BE OPENED NORMALLY, AND THE STENT WAS WITHDRAWN IMMEDIATELY. THEN REPLACED WITH THE PED-500-20 STENT. AFTER THE STENT WAS IN PLACE, PUSH THE STENT TO WITHDRAW THE CATHETER, AND THE STENT OPENED SMOOTHLY. AFTER ANGIOGRAPHY, THE STENT ATTACHED WELL AND THE DISTAL AND PROXIMAL ENDS WERE NORMALLY OPENED. AFTER THE STENT WAS MASSAGED WITH THE GUIDE WIRE, THE SURGICAL EFFECT WAS ACHIEVED, WITH FRONTAL AND LATERAL ANGIOGRAPHY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO CATHETER OR PUSHWI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274805 ↗
• MalfunctionJul 14, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PROXIMAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC ARTERY SEGMENT. THE MAX DI AMETER WAS 11.5MM, AND THE NECK DIAMETER WAS 8.89MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.47MM DISTAL AND 4.79MM PROXIMAL. IT WAS REPORTED THAT DEVICE WAS DELIVERED TO THE DISTAL END OF THE M2, AND WHEN THE MICROCATHETER WAS WITHDRAWN, THE TIP OF THE STENT COULD NOT BE OPENED NORMALLY. AFTER 3 REPEATED ATTEMPTS, THE TIP STILL COULD NOT BE OPENED. THE DEVICE WAS NOT PLACED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED 2 OR LESS TIMES, AND NO OTHER STEPS WERE TAKEN TO OPEN THE DEVICE. THE STENT WAS REMOVED AND REPLACED, AND TREATMENT WAS CHANGED TO STENT-ASSISTED SPRING COIL EMBOLIZATION. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE ANEURYSM WAS COMPLETELY EMBOLIZED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166519 ↗
• MalfunctionMay 19, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE FIRST MICROCATHETER USED WAS A MARKSMAN MICROCATHETER WHICH WAS REPLACED WITH A PHENOM 27 MICROCATHETER. THERE WAS NO ISSUE WITH THE PHENOM 27. THE SECOND PIPELINE (MODEL: PED-500-30) FAILED TO OPEN AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850598 ↗
• MalfunctionApr 26, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT CLINOID SEGMENT. THE MAX DIAMETER WAS 18MM, AND THE NECK DIAMETER WAS 8MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.0MM DISTAL AND 5.1MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT THE MICROCATHETER WAS DELIVERED TO M2, AND THEN THE PIPELINE WAS DELIVERED TO THE END OF THE CATHETER. WHEN THE PIPELINE WAS DEPLOYED, IT WAS OPERATED MANY TIMES, BUT THE TIP STILL COULDN'T BE OPENED. THE PIPELINE AND CATHETER WERE REPLACED. AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE NORMAL. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729406 ↗
• MalfunctionJan 25, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION, AND THE DISTAL END OF THE PHENOM 27 MICROCATHETER HAD ACCORDIONED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY C6. THE MAX DI AMETER WAS 22.5MM, AND THE NECK DIAMETER WAS 18MM. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.45MM DISTAL AND 4.43MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WHICH WAS 9MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED. IT WAS REPORTED THAT AFTER THE PHENOM 27 MICROCATHETER WAS IN PLACE, THE SURGEON PLANNED TO USE A PIPELINE STENT TO TREAT THE ANEURYSM. AFTER THE DISTAL END WAS ANCHORED, THE STENT COULD NO LONGER BE OPENED AFTER IT WAS DEPLOYED ABOUT 5MM, AND THE SUBSEQUENT DEPLOYED PART OF THE STENT WAS ROD-SHAPED. THE SURGEON TRIED TO PUSH AND PULL THE STENT FOR 60 MINUTES, AND THE STENT WAS RETRIEVED REPEATED TWICE, BUT IT WAS NOT OPENED. NO OTHER STEPS WERE TAKEN TO OPEN THE PIPELINE. THE SURGEON QUESTIONED THE PROBLEM WITH THE MICROCATHETER AND THE STENT. AFTER PULLING OUT THE STENT FOR EXTERNAL EXAMINATION, IT WAS FOUND THAT THROMBUS WAS FORMED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227847 ↗
• InjuryDec 21, 2020Unintended Ejection; Physical Resistance/Sticking; Unintended Ejection; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CATHETER AND STENT WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, THE PIPELINE STENT COULD NOT BE PUSHED NORMALLY DUE TO RESISTANCE IN THE PROXIMAL SEGMENT OF THE MARKSMAN MICROCATHETER. THERE WAS NO INJURY TO THE PATIENT REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT CAVERNOUS SINUS WITH A MAX DIAMETER OF 25.4 MM AND A 9.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO DAMAGE TO THE PUSHWIRE OR CATHETER OBSERVED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE. THE STENT COULDN'T BE FULLY RETRIEVED AND THE STENT WAS SEPARATED FROM THE DELIVERY GUIDEWIRE. THE ENTIRE SYSTEM WAS WITHDRAWN AND THE SURGERY WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047303 ↗
• MalfunctionDec 7, 2020Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FAILED TO OPEN, AND BOTH PIPELINES HAD DIFFICULT PLACEMENT DUE TO SYSTEM TENSION RESULTING IN DEVICE REPLACEMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 14MM AND A 9.4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT THE SURGEON SUCCESSFULLY DELIVERED THE PHENOM 27 MICROCATHETER (PLI-30) TO THE MIDDLE CEREBRAL ARTERY M2. THE PIPELINE (PLI-10) WAS DELIVERED IN PLACE, AND DEPLOYED 8MM, BUT THE STENT TIP DID NOT OPEN. THE SURGEON TRIED MULTIPLE TIMES, BUT THE TIP STILL DID NOT OPEN. THE PHENOM 27 AND PIPELINE WERE PULLED TO THE THICKER SIDE OF THE INTERNAL CAROTID ARTERY, AND ANOTHER ATTEMPT WAS MADE TO OPEN THE DEVICE. SYSTEM TENSION CAUSED THE DISTAL PART OF THE ENTIRE SYSTEM TO FALL INTO THE ANEURYSM, AND IT COULD NOT BE PUT IN PLACE FOR DEPLOYMENT AGAIN. THE SURGEON RETRIEVED THE STENT AND WITHDREW THE STENT AND MICROCATHETER. A NEW PHENOM27 (PLI-40) AND PIPELINE (PLI-20) WERE THEN PLACED IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10956487 ↗
• 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 10943298 ↗
• MalfunctionNov 13, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF A CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 31MM AND THE NECK DIAMETER WAS 18MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT WHEN THE PIPELINE WAS IN THE PROCESS OF BEING DEPLOYED BY WITHDRAWING THE MICROCATHETER AND PUSHING THE STENT FORWARD AT THE SAME TIME. IT NOTED THAT THE "FRONT" OF THE STENT COULD NOT BE OPENED EVENT AFTER REPEATED ATTEMPTS. THE PIPELINE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. ALL DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY WAS NORMAL. ANCILLARY DEVICES: PENUMBRA 6F LONG SHEATH

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

  MAUDE report 10839884 ↗
• MalfunctionSep 15, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DISTAL SEGMENT OF THE PIPELINE (PLI-10) FAILED TO OPEN. THE PIPELINE WAS REMOVED FROM THE PATIENT, AND A SECOND PIPELINE (PLI-20) WAS USED. THE SECOND PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE DEVICES WERE NOT POSITIONED IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED, IT WAS UNKNOWN HOW MANY RESHEATHING ATTEMPTS WERE PERFORMED, AND NO ADDITIONAL STEPS WERE DONE TO OPEN THE DEVICES. THE SECOND PIPELINE WAS REMOVED FROM THE PATIENT, AND THE THIRD AND FOURTH PIPELINE WERE DEPLOYED SUCCESSFULLY. 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 ANEURYSM WAS COVERED. ANCILLARY DEVICES INCLUDE A NEURONMAX, PHENOM PLUS, PHENOM27.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10536680 ↗
• MalfunctionSep 2, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE FAILED TO OPEN AND WAS DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC AND POSTERIOR COMMUNICATING (PCOM) ARTERY SEGMENTS WITH A MAX DIAMETER OF 5MM AND A 10MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, BUT THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE VESSEL AT THE DISTAL END OF THE PIPELINE WAS VERY CURVED, AND THE DISTAL END OF THE PIPELINE COULDN'T BE OPENED AFTER DEPLOYMENT. THE IMAGING SHOWED IT WAS LINEAR, AND THE MIDDLE SECTION OF THE PIPELINE COULD BE OPENED NORMALLY. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED, AND RESHEATHING WAS ATTEMPTED LESS THAN THREE TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED TO OPEN THE DEVICE, AND AFTER ALL ATTEMPTS FAILED, THE PIPELINE WAS WITHDRAWN FROM THE PATIENT. AFTER REMOVAL, IT WAS FOUND THE DISTAL END OF THE PIPELINE WAS DAMAGED. 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-PROC

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

  MAUDE report 10486064 ↗
• MalfunctionJul 28, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THERE WERE NO COMPLICATIONS IN THE PROCEDURE PRIOR TO THE PIPELINE STENT FAILURE TO O PEN. THE STENT WAS NOT PLACED IN A VESSEL BEND. THE MICROCATHETER AND INTRACRANIAL SUPPORT CATHETER WERE SHAKEN TO ENCOURAGE THE PIPELINE TO OPEN BUT THIS WAS NOT SUCCESSFUL. THE PIPELINE WAS REMOVED AND A COIL EMBOLIZATION PROCEDURE WAS PERFORMED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10335105 ↗
• MalfunctionJun 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX PUSHWIRE SEPARATED DURING DEPLOYMENT. THE SEPARATION WAS ALLEGED TO HAVE OCCURRED AT THE PROXIMAL MARKER. THE DEVICE AND THE SEPARATED SECTION WERE REPORTED TO HAVE BEEN RETRIEVED. A NEW PIPELINE DEVICE WAS USED TO TREAT THE PATIENT. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT OF A LEFT INTERNAL CAROTID ARTERY (ICA), UNRUPTURED ANEURYSM. THE NECK WAS 7 MM. THE DISTAL LANDING ZONE WAS 3.9 MM AND THE PROXIMAL 4.9 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. THE SEPARATION OCCURRED DURING THE RESHEATHING OF THE DEVICE. THE PHYSICIAN NOTED THAT HE DID NOT FEEL MOVEMENT AND REALIZED IT HAD SEPARATED INSIDE THE DISTAL PORTION OF THE CATHETER. AT THE TIME OF THE OBSERVATION, ONLY ABOUT 1/3RD OF THE DEVICE HAD BEEN DEPLOYED PRIOR TO RESHEATHING. THE ENTIRE SYSTEM WAS REMOVED AND NOTHING REMAINED IN THE PATIENT. RESISTANCE WAS NOT EXPERIENCED WHEN THE PIPELINE WAS ADVANCED THROUGH THE PHENOM. ONLY RESHEATHING ATTEMPT WAS WHEN THE SEPARATION OCCURRED. RESHEATHING WAS ABANDONED AND THE DEVICE AND ALL PARTS OF THE DELIVERY SYSTEM WAS RETRIEVED. THE DEVICE WAS PARTIALLY DEPLOYE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10178695 ↗
• MalfunctionJun 3, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERIOR CAROTID PARAOPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE WAS PREPARED AND USED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE. THE DEVICE WAS DEPLOYED TO THE LOCATION WHERE ANOTHER PIPELINE HAD PREVIOUSLY BEEN PLACED. UPON DEPLOYMENT, THE PROXIMAL END OF THE PIPELINE WOULD NOT OPEN. THE DEVICE WAS RESHEATHED MULTIPLE TIMES BUT THE PROXIMAL END STILL WOULD NOT OPEN. THE SURGEON REMOVED THE PIPELINE WHICH WAS DISCARDED. A NEW PIPELINE OF DIFFERENT MODEL/SIZE WAS USED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10114733 ↗
• MalfunctionApr 17, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX THAT FAILED TO OPEN DURING A PROCEDURE AND WAS DISCOVERED TO BE DAMAGED AFTER REMOVAL. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE RIGHT CAVERNOUS SEGMENT. THE ANEURYSM WAS 25.8 MM WITH A NECK DIAMETER OF 9.67 MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DISTAL SIDE OF PIPELINE WAS UNABLE TO OPEN IN THE BLOOD VESSEL. THE ATTEMPTED TO INCREASE AND DECREASE THE TENSION, PULLED BACK TO THE INTERNAL CAROTID ARTERY, BUT IT WAS STILL UNABLE TO OPEN. AFTER REMOVED OUT OF THE PATIENT'S BODY, PUSHED THE DISTAL SIDE OF PIPELINE FROM MARKSMAN, AND FOUND THAT THE DISTAL SIDE WAS BURR. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9973870 ↗
• MalfunctionJan 22, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RIGHT, SACCULAR, UNRUPTURED ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PROXIMAL END OF THE PIPELINE FAILED TO OPEN AND DID NOT FULLY DEPLOY AFTER SEVERAL ATTEMPTS. THE PIPELINE WAS REMOVED AND REPLACED WITH A SHORTER PIPELINE (5.0X20) AND IMPLANTED SUCCESSFULLY. NO ISSUES WERE REPORTED WITH THE MICROCATHETERS USED. 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 DEVICES INCLUDE A PHENOM PLUS AND PHENOM27.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9616062 ↗
• MalfunctionApr 10, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL TIP WOULD NOT OPEN COMPLETELY. IT OPENED 80% BUT RADIOGRAPHICALLY IT WAS NOT OPEN AND WOULD NOT OPEN. MORE THAN 50 % OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PATIENT WAS BEING TREATED FOR RIGHT ICA, UNRUPTURED, AND SACCULAR. THE MAX DIAMETER AND THE NECK DIAMETER WERE BOTH 5MM. THE DISTAL AND PROXIMAL LANDING ZONE WERE BOTH 8MM. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501929 ↗
• InjuryAug 13, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT OF INTRAPROCEDURAL PIPELINE FLEX FAILURE TO OPEN AS WELL AS VESSEL OCCLUSION. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT OF AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE RIGHT, CAVERNOUS INTERNAL CAROTID ARTERY (ICA). VESSEL TORTUOSITY WAS DESCRIBED AS SEVERE. THE ANEURYSM MAX. DIAMETER WAS 20 MM AND NECK DIAMETER WAS 11 MM. THE LANDING ZONE WAS 3 MM DISTAL AND 4.9 MM PROXIMAL. THE PATIENT HAD BEEN ADMINISTERED DUAL ANTIPLATELETS AND WAS WITHIN THE THERAPEUTIC RANGE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A PIPELINE FLEX 5 X 30 MM WAS ATTEMPTED TO BE PLACED. THE PIPELINE FLEX REPORTEDLY DID NOT OPEN ON THE DISTAL END WHEN INITIALLY DEPLOYED. AFTER FULL DEPLOYMENT, THE PROXIMAL END WAS ALSO FLATTENED. WHEN CAPTURING THE DELIVERY WIRE, THE CATHETER WAS USED TO OPEN UP THE FLATTENED PROXIMAL SECTION OF THE PIPELINE FLEX. TO OPEN THE DISTAL END, A J-CURVE WIRE WAS USED THEN BALLOON ANGIOPLASTY, WHICH RESULTED IN THE PIPELINE FLEX OPENING AND APPOSING TO THE VESSEL WALL. WHEN THE BALLOON WAS DEFLATED, THE VESSELS DISTAL TO THE PIPELINE FLEX (PCOM, DISTAL ICA, ANTERIOR CEREBRAL ARTERY) WERE OCCLUDED. A BALLOON WAS INFLATED AT THE OCCLUSION SITE T

  Patient problems: Infarction, Cerebral; Nerve Damage; Occlusion; Paralysis

  MAUDE report 7779521 ↗

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