PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00763000284732), received between Jun 9, 2021 and Mar 26, 2026 — classified as 2 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (50 reports).

12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT TIP DID NOT OPEN. THE PATIENT WAS UNDERGOING BLOOD FLOW-DIVERTING STENT IMPLANTATION PROCEDURE FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED INTERNAL CAROTID ARTERY C4 SEGMENT ANEURYSM. IT HAD A MAX DIAMETER OF 9.8 MM AND A 6.1 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.9 MM. THE LANDING ZONE WAS 4.6 MM DISTALLY AND 5.0 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED HE VESSEL WAS IN GOOD CONDITION, WITH NO RUPTURE AND NO SIGNIFICANT STENOSIS. IT WAS REPORTED THAT BASED ON THE VESSEL DIAMETER, THE OPERATOR SELECTED A 5.0 × 25 PIPELINE (PED2) STENT. AFTER THE ACCESS ROUTE AND MICROCATHETER WERE IN PLACE, THE PED2 WAS UNPACKED AND ADEQUATELY HYDRATED ACCORDING TO STANDARD PROCEDURE, THEN ADVANCED TO THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE OPERATOR BEGAN WITHDRAWING THE PHENOM 27 (P27) MICROCATHETER TO ATTEMPT PED2 DEPLOYMENT. WHILE WITHDRAWING THE P27 AND DEPLOYING THE PED2, IT WAS NOTED THAT THE TIP END OF THE PED2 DID NOT OPEN. DEPLOYMENT WAS CONTINUED WITH REPEATED PUSH¿PULL MANEUVERS, BUT THE TIP END STILL FAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698707 ↗
• MalfunctionJan 26, 2026Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED, NOR WAS THE CAUSE OF THE DAMAGE OR WHETHER IT WAS DUE TO FRICTION WITHIN THE PHENOM. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. BECAUSE THE TIP COULD NOT BE OPENED, AN ATTEMPT WAS MADE TO RETRACT AND THEN DEPLOY IT, BUT THIS WAS UNSUCCESSFUL. NO KINK OR DAMAGE WAS OBSERVED ON THE CATHETER AFTER REMOVAL, AND NO FRICTION OR RESISTANCE WAS ENCOUNTERED DURING DELIVERY OR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182707 ↗
• MalfunctionJan 23, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160982 ↗
• MalfunctionJan 9, 2026Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING A PROCEDURE VIA FEMORAL ARTERY ACCESS FOR FLOW DIVERSION STENT TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) C4 SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.6MM AND THE NECK DIAMETER WAS 3.2MM. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE PIPELINE TIP END COULD NOT BE OPENED. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE AND ATTEMPT TO OPEN, BUT THE STENT COULD NOT BE OPENED. THE SYSTEM WAS REMOVED AND BOTH THE PIPELINE AND THE PHENOM 27 MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATE WITH THIS EVENT. ANCILLARY DEVICE: NAVIEN DISTAL ACCESS CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026634 ↗
• MalfunctionJan 6, 2026Material Deformation; No Apparent Adverse Event; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY OF PED2 USING THE PHENOM 27, A BURR WAS OBSERVED AT THE PIPELINE'S TIP END. THE PATIENT WAS UNDERGOING DENSE MESH STENT IMPLANTATION FOR ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6MM. IT WAS REPORTED THAT THE TIP END OF THE STENT COULD NOT BE OPENED. AFTER REPEATED ATTEMPTS, IT WAS EVENTUALLY OPENED, BUT UNDER DSA FLUOROSCOPY, OBVIOUS BURR WAS OBSERVED AT THE STENT¿S TIP END. THE IMPLANTATION WAS ABANDONED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979287 ↗
• MalfunctionJan 5, 2026Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE C6 SEGMENT ANEURYSM WAS LOCATED ON THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957468 ↗
• MalfunctionDec 17, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED. THERE WAS NO FRICTION DURING DELIVERY OR POSITIONING OF THE PIPELINE. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR THE CATHETER. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN THE FAILURE TO OPEN OCCURRED; IT WAS POSITIONED IN A STRAIGHT SEGMENT. MULTIPLE ATTEMPTS WERE MADE TO RETRACT AND REDEPLOY, SWING, BUT MANEUVERS WERE NOT SUCCESSFUL IN OPENING THE PIPELINE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829549 ↗
• MalfunctionDec 15, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO OPEN OR ROUGHNESS WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN; IT WAS IN A STRAIGHT SEGMENT. ADDITIONAL STEPS WERE TAKEN, INCLUDING RETRIEVAL AND REDEPLOYMENT OF THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803516 ↗
• MalfunctionNov 7, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR ADVANCED THE PHENOM 27 TO THE M2 AS PER STANDARD PROCEDURE AND BEGAN DELIVERING THE DEVICES. DUE TO A SOMEWHAT TORTUOUS PATH, THE OPERATOR ADVANCED THE MICROCATHETER TO A HIGHER POSITION AND STARTED DELIVERING THE STENT. THE OPERATOR REPORTED SOME RESISTANCE DURING DELIVERY, BUT THE STENT WAS STILL SUCCESSFULLY POSITIONED. WHEN STARTING TO DEPLOY THE STENT, THE OPERATOR FIRST WITHDREW THE MICROCATHETER TO ABOUT 9 MM; THE STENT¿S TIP END WAS IN THE STRAIGHT SEGMENT OF THE M1, BUT THE TIP END OF THE STENT DID NOT OPEN. AFTER WAITING 40 SECONDS, THE STENT STILL DID NOT OPEN, SO THE ENTIRE SYSTEM WAS PULLED BACK TO THE INTERNAL CAROTID ARTERY, BUT THE STENT STILL DID NOT OPEN. THE OPERATOR THEN ATTEMPTED RETRIEVAL AND REPEATED THE PREVIOUS STEPS. THE MIDDLE SEGMENT OF THE STENT OPENED SLIGHTLY, BUT THE TIP END HAD POOR SHAPE. THE CUSTOMER ATTEMPTED TO PUSH THE DELIVERY GUIDEWIRE, BUT THE TIP END OF THE STENT STILL DID NOT OPEN. AFTER REPEATED ATTEMPTS, THE TIP END OF THE STENT WAS COMPLETELY DEFORM ED, SO THE STENT WAS REPLACED. THE SAME ISSUE OCCURRED WITH THE SECOND STENT. THE OPERATOR THEN SWITCHED TO A THIRD STENT WITH A 4.75 MM DIAMETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498661 ↗
• MalfunctionSep 4, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FLEX WITH SHIELD STENT WAS DELIVERED WITHOUT EVERTED SLEEVE, WAS MISSHAPED, HAD INCOMPLETE OPENING, AND HAD BURRS, AND ANOTHER ONE HAD POOR WALL APPOSITION. THE PATIENT WAS UNDERGOING DENSE MESH STENT FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, AMORPHOUS, INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE ARTERY DIAMETER WAS 4.3 MM DISTALLY AND 4.8 MM PROXIMALLY. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NORMAL BLOOD VESSELS AND POOR STENT OPENING. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE FIRST STENT, PED2-475-30, WAS OPENED WITHOUT AN EVERTED SLEEVE. WHEN THE TIP WAS EXPOSED, IT APPEARED TRUMPET-SHAPED. THE SURGEON EVEN COMMENTED ON HOW EASY IT WAS TO OPEN, HOWEVER, AFTER A SHORT DEPLOYMENT, THE SHAPE WAS INCORRECT, SO THE STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964532 ↗
• MalfunctionSep 2, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE FAILURE OCCURRED IN THE DISTAL SECTION OF THE PIPELINE. THE DEVICE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN THE ISSUE WAS OBSERVED. NO ADDITIONAL STEPS OR ADJUNCTIVE DEVICES, SUCH AS RESHEATHING, WIRE/CATHETER MANIPULATION, OR BALLOON ASSISTANCE, WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945564 ↗
• MalfunctionJul 28, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING A PROCEDURE TO TREAT AN OPHTHALMIC ARTERY UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER MEASUREMENTS WERE TAKE AND THE 5 X 18 PIPELINE WAS SELECTED, THE PHENOM 27 MICROCATHETER WAS DELIVERED IN PLACE. DEPLOYMENT OF THE PIPELINE WAS INITIATED BUT THE TIP FAILED TO OPEN. REPEATED ATTEMPTS TO RETRIEVE AND REDEPLOY THE PIPELINE WERE DONE BUT THE PIPELINE TIP STILL FAILED TO OPEN. THE PIPELINE WAS RETRIEVED ALONG WITH THE PHENOM 27 MICROCATHETER. THE PIPELINE WAS EXAMINED IN VITRO AND THE TIP OF THE STENT WAS FRIZZY AND SLIGHTLY DAMAGED. BOTH THE PIPELINE AND PHENOM MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. POST PROCEDURE ANGIOGRAPHY SHOWED BLOOD RETENTION IN THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631320 ↗
• MalfunctionJul 9, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT SMALL ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT WAS TREATED WITH BLOOD FLOW-GUIDED DENSE MESH STENT IMPLANTATION. THE 6F 90CM LONG SHEATH WAS SUCCESSFULLY GUIDED BY THE MULTIFUNCTIONAL ANGIOGRAPHY CATHETER AND THE 0.035-INCH LOACH GUIDEWIRE TO THE C3 SEGMENT OF THE INTERNAL CAROTID ARTERY. THE 6F 115CM TONGQIAO SILVER SNAKE INTERMEDIATE CATHETER WAS FURTHER PUSHED TO GO UPPER TO THE CAVERNOUS SINUS SEGMENT. 3D ROTATIONAL ANGIOGRAPHY WAS PERFORMED, AND PED2-500-25 WAS SELECTED BASED ON THE MEASUREMENT. THE STENT CATHETER PHENOM27 SUCCESSFULLY REACHED THE IPSILATERAL BRAIN UNDER THE GUIDANCE OF THE SYCHRO GUIDEWIRE. MICROCATHETER ANGIOGRAPHY CONFIRMED THAT EVERYTHING WENT WELL. THE STENT WAS FULLY HYDRATED WITH HIGH-PRESSURE SALINE AND SUCCESSFULLY DELIVERED TO THE DISTAL END OF THE STENT CATHETER PHENOM27. AT THIS TIME, EVERYTHING WENT WELL. THE SURGEON CHOSE TO OPEN THE STRAIGHT SEGMENT IN THE BRAIN AND DEPLOY A SUFFICIENT DISTANCE OF MORE THAN 1CM. THE STENT TIP END DID NOT OPEN AND WAS TIGHTLY HELD TOGETHER. AFTER WAITING FOR 30 SECONDS, THE STENT TIP END STILL COULD NOT BE OPENED. THE WHOLE BODY SWUNG SLIGHTLY, BUT THE TIP END STILL COULD NOT BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459630 ↗
• MalfunctionJun 9, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM27 MICROCATHETER WAS GUIDED BY THE NERVE GUIDEWIRE AND WAS PUSHED TO GO UPPER TO THE END OF THE LEFT MIDDLE CEREBRAL ARTERY M1, AND THE MICRO-GUIDEWIRE WAS WITHDRAWN. AFTER THE PED2-500-25 DENSE MESH STENT WAS FULLY HYDRATED, IT WAS DELIVERED AND PUSHED TO GO UPPER THROUGH THE PHENOM27 CATHETER. THE STENT HAD A LARGE RESISTANCE WHEN PASSING THROUGH THE CAVERNOUS SINUS OF THE INTERNAL CAROTID ARTERY. THE SURGEON OBSERVED THAT THE ACCESS SYSTEM WAS STABLE AND NORMAL, AND CONTINUED TO DELIVER THE STENT TO THE END OF THE MICROCATHETER WITH A CERTAIN TENSION. THE PHONM27 WAS WITHDRAWN IN SITU IN THE STRAIGHT SECTION OF M1 TO DEPLOY THE STENT. IT WAS OBSERVED THAT THE TIP END WAS FISH-MOUTHED AND NOT OPENED. MORE LENGTH WAS DEPLOYED AND A CERTAIN TENSION WAS APPLIED TO PUSH THE STENT, BUT THE PROBLEM COULD NOT BE SOLVED. THEN THE STENT WAS COMPLETELY RETRIEVED INTO THE MICROCATHETER, THE MIDDLE CATHETER WAS PUSHED TO GO UPPER, AND IT WAS DEPLOYED AGAIN. AT THIS TIME, THERE WAS OBVIOUS RESISTANCE DURING THE DEPLOY PROCESS, AND THE TIP END OF THE STENT STILL COULD NOT BE OPENED. IT WAS FOUND THAT THE TIP END OF THE STENT WAS ABNORMAL, AND THE STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169909 ↗
• MalfunctionMay 21, 2025Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END AND AND PHENOM 27 MICROCATHETER THAT HAD RESISTANCE DURING THE SAME PROCEDURE. THE PATIENT WAS UNDERGOING A PROCEDURE VIA RADIAL ACCESS FOR FLOW DIVERTER TREATMENT OF A LEFT OPHTHALMIC ARTERY UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 8.7MM AND THE NECK DIAMETER WAS 5.6MM. THE DISTAL LANDING ZONE WAS 4.3MM AND THE PROXIMAL LANDING ZONE WAS 5.2MM. VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE PIPELINE WAS DELIVERED IN THE STRAIGHT SECTION OF THE MIDDLE CEREBRAL ARTERY (MCA), WHEN LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED, THE DISTAL END OF THE PIPELINE COULD NOT BE OPENED. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE STENT WAS RESHEATHED TWO OR LESS TIMES. THERE WERE NO OTHER STEPS OR DEVICE USED TO OPEN THE PIPELINE. MULTIPLE ADJUSTMENTS WERE MADE BUT THE STENT STILL COULD NOT BE OPENED AND WAS PRESENTING IN A Y-SHAPE AT THE TIP END. THEREFORE, THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT'S BODY W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062839 ↗
• MalfunctionApr 21, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD (PED2) STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE VIA FEMORAL ACCESS FOR FLOW DIVERSION TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY (R-ICA) POSTERIOR COMMUNICATING (PCOM) SEGMENT UNRUPTURED AMORPHOUS ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6.54MM AND THE NECK DIAMETER WAS 5.1MM. THE DISTAL LANDING ZONE WAS 3.43MM AND THE PROXIMAL LANDING ZONE WAS 5.4MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT OF THE PIPELINE, THE DISTAL TIP FAILED TO OPEN IN THE STRAIGHT MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. THE MICROCATHETER WAS WITHDRAWN TO DEPLOY MORE THAN 1CM OF THE PIPELINE STENT BUT IT STILL COULD NOT BE OPENED. THE PIPELINE WAS RESHEATHED AND REDEPLOYED TWICE BUT STILL FAILED TO OPEN. THE SURGEON CONTINUED TO WAIT AND SWUNG THE STENT SLIGHTLY BUT IT COULD NOT BE OPENED. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND. FINALLY, THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER AND REPLACED WITH A PIPELINE SHIELD MODEL: PED2-500

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878041 ↗
• MalfunctionApr 17, 2025Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PIPELINE FAILED TO OPEN IN THE TIP END. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE INCLUDING RETRIEVING, PUSH-PULL AND OTHER OPERATIONS. THE PIPELINE WAS RESHEATHED 0 TIMES. THERE WAS NO VISIBLE DAMAGE TO THE PHENOM MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860316 ↗
• MalfunctionMar 7, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PIPELINE FAILURE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546917 ↗
• MalfunctionFeb 18, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 7MM AND A 6MM NECK DIAMETER. THE LANDING ZONE WAS 4.8MM DISTALLY AND 4.9MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AFTER CHANGING TO THE 4.75-25 MODEL, THE ANEURYSM CONTRAST AGENT RETENTION WAS OBVIOUS AND THE OPERATION WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE PUNCTURE WAS PERFORMED NORMALLY UNTIL THE MICROCATHETER PHENOM 27 WAS IN PLACE TO M2 WAS NORMAL. THE 5.0-25 STENT WAS SELECTED AND PUSHED. AFTER THE STENT WAS IN PLACE, THE STENT WAS DEPLOYED AND CATHETER WAS WITHDRAWN IN THE STRAIGHT SECTION. AFTER WITHDRAWING 10MM, IT DID NOT OPEN. AFTER WITHDRAWING 5MM, IT STILL DID NOT OPEN. SO IT WAS RESHEATHED TO DEPLOY IN THE STRAIGHT SECTION, BUT IT STILL DID NOT OPEN. REPEATED THIS OPERATION ONCE. THE TIP END LOOKED ROUGH UNDER THE IMAGE, SO THE WHOLE SYSTEM WAS REMOVED AND THE MICROCATHETER AND STENT WERE REPLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398440 ↗
• MalfunctionJan 8, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE FAILURE OF THE DEVICE WAS DETERMINED TO BE A FLAW OF THE PRODUCT AS PER THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107737 ↗
• MalfunctionNov 5, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE SHIELD STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR EMBOLIZATION OF A C6 SEGMENT LATERAL WALL UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.96MM AND THE NECK DIAMETER WAS 4.83MM. THE DISTAL LANDING ZONE WAS 3.75MM AND PROXIMAL LANDING ZONE WAS 5.22MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICE WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). WHEN LESS THAN 50% OF THE PIPELINE STENT WAS DEPLOYED, THE DISTAL TIP COULD NOT BE OPENED. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED LESS THAN 2 TIMES; NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. IT WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PIPELINE WAS THEN REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY SHOWED NORMAL BLOOD FLOW IN THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608794 ↗
• MalfunctionOct 30, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE SHIELD DISTAL END WAS OPENED POORLY, AND RETRACTED WHEN MASSAGED. WHEN TREATING AN ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY SEGMENT, AFTER THE MICROCATHETER WAS IN PLACE, THE PIPELINE WAS DELIVERED AND DEPLOYED, AND IT WAS FOUND THAT THE DISTAL END WAS POORLY OPENED. AFTER REPEATED RETRIEVAL AND TENSION INCREASE AND DECREASE OPERATIONS, IT STILL COULD NOT BE OPENED. THE STENT WAS CONTINUED TO BE PUSHED OUT, AND IT WAS FOUND THAT THE MIDDLE SECTION WAS BETTER OPENED. THEREFORE, THE STENT WAS DEPLOYED AFTER RESERVING SUFFICIENT LENGTH AT THE DISTAL END. DURING THE PROCESSING J-TYPE GUIDEWIRE MASSAGE, THE MICRO-GUIDEWIRE FORMED A LOOP TO MASSAGE THE POORLY OPENED DISTAL END OF THE STENT. THE DISTAL END WAS DIRECTLY RETRACTED TO THE PROXIMAL END OF THE ANEURYSM NECK, AND UNDER FLUOROSCOPY, IT WAS SEEN THAT THE BRAIDED WIRE AT THE DISTAL END OF THE STENT WAS DAMAGED, COLLAPSED AND SQUEEZED. THEREFORE, ANOTHER PIPELINE WAS USED, DELIVERED AND DEPLOYED AGAIN TO BRIDGE AND COVER THE ANEURYSM NECK, AND THE OPERATION WAS COMPLETED. THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. MO

  Patient problems: Failure of Implant

  MAUDE report 20569813 ↗
• MalfunctionJul 9, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN. THE PED WAS DELIVERED TO THE DISTAL M1. DURING THE OPENING PROCESS OF THE TIP END, IT WAS FOUND THAT THE TIP END COULD NOT BE OPENED NORMALLY. AFTER RETRIEVING AND PUSHING AND PULLING OPERATIONS, IT STILL COULD NOT BE OPENED. THE STENT WAS REPLACED TO COMPLETE THE OPERATION. IT FAILED TO OPEN IN THE DISTAL SECTION. LESS THAN 50% HAD BEEN DEPOLYED WHEN IT FAILED TO OPEN. IT WAS NOT PLACED IN A BEND WHEN IT FAILED TO OPEN. THE PIPELINE WAS WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN 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, SACCUALR ANUERYSM IN THE LEFT CAVEROUS SINUS. THE MAX DIAMETER WAS 5.1MM AND THE NECK DIAMETER WAS 8MM. THE DISTAL LANDING ZONE WAS 4.3MM AND THE PROXIMAL LANDING ZONE WAS 5.1MM. VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698349 ↗
• MalfunctionJul 8, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689121 ↗
• MalfunctionJun 17, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE FEEDBACK DURING THE DELIVERY PROCESS WAS GREATER THAN USUAL. THE PIPELINE WAS BEEN PLACED IN A VESSEL BEND WHEN IT FAIELD TO OPEN. IN AN ATTEMPT TO OPEN THE PIPELINE IT WAS RETRIEVED INTO THE MICROCATHETER TWICE. THE PIPELINE WAS NOT RESHEATHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548073 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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-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