PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00763000284725), received between Nov 3, 2021 and Sep 9, 2026 — classified as 3 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (45 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Structural Problem; Activation Failure

  Patient problems: Cognitive Changes; Failure of Implant; Headache; Ischemia

  MAUDE report 50694256 ↗
• MalfunctionApr 23, 2026Use of Device Problem; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT PIPELINE FAILED TO OPEN DISTALITY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE R OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE WAS 4.3MM DISTALLY AND 4,9 PROXIMALLY. IT WAS NOTED THE PATIENT'S BLOOD VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PHYSICIAN STARTED TO DEPLOY PIPELINE IN M1 BY UNSHEATHING THE TIP COIL AND PUSHING OUT THE DEVICE. HE WAS UNSATISFIED WITH THE OPENING SO HE DECIDED TO RESHEATH. PHYSICIAN SUBSEQUENTLY DEPLOYED AND RESHEATHED THE DEVICE 3 MORE TIMES. ON THE 4TH DEVICE DEPLOYMENT, THE DISTAL END OF THE PIPELINE WAS SIGNIFICANTLY FRAYED UPON OPENING. IT WAS MENTIONED TO THE PHYSICIAN AND WE DECIDED TO REMOVE THE DEVICE AND TRY WITH A NEW DEVICE. THE PIPELINE FAILED TO OPEN AT THE DISTAL SECTION, AND MORE THAT 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS ALSO RESHEATED MORE THAT 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. BOTH THE PIPELINE AND THE CATHETER WERE RESHEATHED AND REMOVED FROM THE PATIENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT WAS NOT APPROVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968333 ↗
• MalfunctionMar 2, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. THE REPORT THAT THE PHENOM 27 MICROCATHETER WAS NO LONGER USABLE MEANS THAT THE STENT COULD NOT BE RETRIEVED INTO THE PHENOM MICROCATHETER AND BECAME STUCK. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. REPEATED ATTEMPTS WERE MADE TO OPEN THE PIPELINE BY RETRIEVING AND REDEPLOYING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484377 ↗
• MalfunctionFeb 9, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO DEPLOY WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR OTHER DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE, AS IT COULD NOT BE RESHEATHED OR FULLY DEPLOYED, AND THE GUIDEWIRE, CATHETER, AND BALLOON COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291195 ↗
• MalfunctionDec 29, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY LATERAL WALL, C4 WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.5 MM AND PROXIMAL: 5.2 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SERIAL ANEURYSMS IN THE C5 AND C6 SEGMENTS. IT WAS REPORTED THAT THE TIP OF THE PIPELINE COULD NOT BE OPENED INSIDE THE PATIENT'S BODY DESPITE PUSHING, PULLING, INCREASING OR DECREASING TENSION, THE TIP REMAINED CLOSED. AFTER WITHDRAWAL FROM THE PATIENT'S BODY, IT COULD ONLY BE OPENED USING A NEEDLE TO PRY IT OPEN. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT BY RESHEATHING AND REMOVING WITH THE MICROCATHETER. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905414 ↗
• MalfunctionNov 24, 2025Positioning Failure; Material Frayed; Material Deformation; Activation Failure; Positioning Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE DAMAGE, SPECIFICALLY THE BURRS OBSERVED, WAS NOT DETERMINED. THE FAILURE TO DE PLOY MAY HAVE BEEN DUE TO THE MIDDLE CEREBRAL ARTERY BEING TOO THIN RELATIVE TO THE STENT DIAMETER. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN, AND THE DEVICE WAS PLACED IN A STRAIGHT VESSEL SEGMENT AT THE TIME OF FAILURE. THE MICROCATHETER WAS RETRIEVED DURING THE PROCEDURE, BUT NO OTHER ADDITIONAL DEVICES OR TECHNIQUES WERE ATTEMPTED TO OPEN THE PIPELINE. UNEVEN BRAIDED YARN AT THE TIP END WAS OBSERVED AS THE TYPE OF DAMAGE, AND THIS IRREGULARITY WAS DISCOVERED ONLY AFTER ATTEMPTED OPENING AND IN SITU DEPLOYMENT; NO ABNORMALITIES WERE VISIBLE PRIOR TO USE. DIFFICULTY IN OPENING THE STENT TIP RESULTED IN PROCEDURAL DELAY, REQUIRING THE TIP ENDTO BE RETRIEVED AND THE ENTIRE DEVICE WITHDRAWN TO THE INTERNAL CAROTID ARTERY BEFORE REDEPLOYMENT. THE PATIENT WAS NOT EXPOSED TO ANY RISK OR COMPLICATION AS A RESULT OF THE FAILED DEPLOYMENT. SIMILAR ISSUES HAVE BEEN EXPERIENCED PREVIOUSLY, MOST FREQUENTLY WITH STENT DIAMETERS OF 4.75 AND 5.00. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED ACCORDING TO THE IFU DURING THE PROCEDURE, AND NO ALTERNATIVE DEVICE

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632413 ↗
• MalfunctionNov 21, 2025Material Frayed; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE SHIELD THAT FAILED TO OPEN AT THE DISTAL END AND APPEARED DAMAGED, THEN HAD RESISTANCE IN THE MARKSMAN MICROCATHETER WITH RESHEATHING AND REDEPLOYING. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF A LEFT OPHTHALMIC ARTERY UNRUPTURED AMORPHOUS ANEURYSM VIA FEMORAL ARTERY ACCESS. THE ANEURYSM MAX DIAMETER WAS 5.4MM AND THE NECK DIAMETER WAS 4.3MM. THE DISTAL LANDING ZONE WAS 3.8MM; THE PROXIMAL LANDING ZONE WAS 5.1MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). AFTER POSITIONING, DEPLOYMENT OF THE STENT WAS INITIATED. DURING DEPLOYMENT, THE STENT TIP APPEARED ROUGH AND COULD NOT BE FULLY OPENED. EVEN AFTER DEPLOYING 15MM OF THE STENT, IT STILL COULD NOT BE OPENED. LESS THAN 50% OF THE STENT WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE OPERATOR ATTEMPTED TO RETRIEVE AND REDEPLOY THE STENT, BUT FOUND THAT THE STENT COULD NEITHER BE RETRIEVED NOR REDEPLOYED AND WAS STUCK AT THE DISTAL END THE CATHETER. THE PIPELINE WAS RESHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623743 ↗
• MalfunctionNov 21, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY AND HAD A FRAYED APPEARANCE ON THE DISTAL BRAID. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 30 MM AND A 30 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 200. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL PIPELINE PLACEMENT. IT WAS REPORTED THAT THE PHYSICIAN HAD PLACED A NON-MEDTRONIC SHEATH IN PROXIMAL RIGHT ICA AND THE NAVIEN WAS PLACED PROXIMAL TO DISEASED ICA APPROXIMATELY HORIZONTAL PETROUS, THE PHENOM 27 WAS ADVANCED OVER A NON-MEDTRONIC GUIDEWIRE INTO THE RIGHT M2 BRANCH. THE PIPELINE WAS ADVANCED TO THE TIP OF THE PHENOM 27, AND THE PHYSICIAN UNSHEATHED THE TIP COIL AND PUSHED THE DELIVERY WIRE TO OPEN DEVICE. THE PHYSICIAN PUSHED APPROXIMATELY ONE THIRD TO ONE HALF OF THE DEVICE, AND THE DISTALPIPELINE WAS NOT OPENING. THE PHYSICIAN PULLED BACK THE DEVICE TO M1; HOWEVER, THE DISTAL DEVICE STILL WOULD NOT OPEN. THE PHYSICIAN RECAPTURED THE DEVICE TO PUSH PTFE SLEEVES FORWARD, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622587 ↗
• MalfunctionNov 18, 2025Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT BROKE AT THE END OF THE CATHETER. THE CATHETER WAS BROKEN WHILE THE REST OF THE CATHETER WAS IN THE PATIENT'S BODY. NO PIECES BROKEN WERE INSIDE THE PATIENT AND ALL WERE COLLECTED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583164 ↗
• MalfunctionNov 17, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO CONCOMITANT DEVICE OR DEVICE COMPONENT WAS INVOLVED WITH THE MID-CATHETER RESISTANCE. RESISTANCE WAS ENCOUNTERED DURING DELIVERY. THE CAUSE OF THE STENT FAILURE TO OPEN AND RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. STENT DEFORMATION WAS OBSERVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL ATTEMPTS TO OPEN WERE TRIED. AFTER STENT RETRIEVAL, PUSHED THE INTERMEDIATE CATHETER TO GO UPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571990 ↗
• MalfunctionNov 3, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT LESION CHARACTERISTICS INCLUDE: ANEURYSM AT C5 OF THE INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS MINIMAL. THE PATIENT IS RECOVERING WELL AFTER THE SURGERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE ARE NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT, ANGIO, ETC.) AVAILABLE. THE CAUSE OF THE STIFFNESS WAS NOT DETERMINED. THE RESISTANCE WAS LOCATED IN THE MIDDLE AND DISTAL SECTION OF THE CATHETER. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. THE OBSERVED DAMAGE TO THE PIPELINE WAS DEFORMATION AT THE TIP END AND AN INCOMPLETELY OPENED STATE. A PHENOM27 CATHETER WAS USED, LOT NUMBER 230663927. THE TIP OF THE PIPELINE FAILED TO OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. IT WAS LOCATED IN THE STRAIGHT SECTION OF THE BLOOD VESSEL. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452325 ↗
• MalfunctionOct 23, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS RESISTANCE IN THE DISTAL/TIP SECTION OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS A DMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368143 ↗
• MalfunctionOct 15, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE PIPELINE¿S FAILURE TO OPEN AND THE ROUGH SURFACE WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, AND NO ADDITIONAL STEPS OR OTHER DEVICES (SUCH AS RESHEATHING, WIRE, CATHETER, OR BALLOON) WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283320 ↗
• MalfunctionAug 6, 2025Material Frayed; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure; Material Frayed; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE DISTAL END OF THE STENT WAS OPENED, THE PROXIMAL END REMAINED BAR-SHAPED AND FAILED TO OPEN. VARIOUS MANIPULATION TECHNIQUES WERE ATTEMPTED BUT COULD NOT OPEN IT, AND THE FRONT END WAS FOUND TO BE FRAYED. ANCILLARY DEVICES INCLUDE A 8F CORDIS GUIDE CATHETER, MARKSMAN MICROCATHETER, SYNCHRO14 GUIDEWIRE. THERE WAS FAILURE TO OPEN IN THE MIDDLE SECTION. THE PIPELINE POSITIONED WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE.  THE PIPELINE WAS REMOVED FROM PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU.    THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE WAS 4.2 MM DISTAL AND 5.1 MM PROXIMAL. IT WAS NOTED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730142 ↗
• MalfunctionJul 29, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 5MM DISTALLY AND 4.5MM PROXIMALLY. THE ACCESS VESSEL WAS A FEMORAL ARTERY, WITH 6MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN.  IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON ENCOUNTERED AN ISSUE; THAT THE TIP OF THE FIRST PIPELINE PED STENT COULDN'T BE OPENED. IT WAS REPLACED WITH A SECOND STENT, WHICH STILL FAILED TO OPEN. DURING THE PROCEDURE, ATTEMPTS SUCH AS PUSHING, PULLING, AND RETRIEVAL WERE MADE, BUT THE STENTS STILL COULD NOT BE OPENED. AFTER REPLACED IT WITH A THIRD STENT, THE PROCEDURE WAS COMPLETED. THE EXACT CAUSE OF THE STENT OPEN FAILURE REMAINED UNCLEAR. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS INTRACRANIAL ANEURYSM. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647071 ↗
• MalfunctionJul 17, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE MESH STENT COULD NOT OPEN. THE MIDDLE SECTION OF THE STENT WAS DEPLOYED, BUT THE FRONT END REMAINED UNOPENED. ULTIMATELY, THE CATHETER WAS UNABLE TO RETRIEVE THE STENT. AFTER MORE THAN TWO ATTEMPTS TO RETRIEVE IT, THE ISSUE REMAINED UNRESOLVED. THEREFORE, BOTH WERE REMOVED TOGETHER AND A COMPLAINT WAS FILED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED LEFT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 4.6MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.8MM AND PROXIMAL: 4.9MM. PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 10MM DIAMETER. PATIENT WAS NOTED TO HAVE A MEDICAL HISTORY OF HYPERTENSION. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, PRU LEVEL MET THE STANDARD. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD FLOW WAS SMOOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531596 ↗
• MalfunctionJul 16, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER MULTIPLE OPERATIONS, THE STENT TIP STILL DID NOT OPEN PROPERLY. THE MEDICAL TEAM WERE CONCERNED THAT THE PHENOM 27 MIGHT ALSO HAVE PROBLEMS, SO THEY REPLACED ALL OF THEM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, LEFT SIDE, OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH SIZE 3.51MM AND A NECK DIAMETER OF 5.05MM. VESSEL TORTUOSITY WAS MODERATE. THE PATIENT RECOVERED WELL FROM THE PROCEDURE. THEY EXPERIENCED NO SYMPTOMS RELATED TO THE FAILURE TO OPEN. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO ISSUES WITH THE PHENOM 27 CATHETER (MODEL: FG15150-0615-1S, LOT: 229655205). THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR OTHER DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519300 ↗
• MalfunctionJul 3, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE PIPELINE WAS RETRIEVED AND REDEPLOYED BUT DID NOT SUCCEED IN OPENING THE PIPELINE. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398298 ↗
• MalfunctionJun 12, 2025Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM27 WAS GUIDED BY A NERVE GUIDEWIRE AND MOVED UP TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, AND THE GUIDEWIRE WAS WITHDRAWN. AFTER THE PED2-500-20 STENT WAS FULLY HYDRATED, IT WAS TRANSPORTED UP THROUGH THE PHENOM CATHETER. WHEN PASSING THROUGH THE CAVERNOUS SINUS SEGMENT, THE SURGEON REPORTED THAT THE RESISTANCE WAS LARGE, SO THE MICROCATHETER TENSION WAS DEPLOYED AND THE STENT CONTINUED TO BE DELIVERED. THE STENT TIP WAS DEPLOYED AT THE BEGINNING, THE STENT PUSH GUIDEWIRE REMAINED STATIONARY, AND THE MICROCATHETER WAS WITHDRAWN. AFTER DEPLOYING A CERTAIN LENGTH, THE STENT TIP END DID NOT OPEN. HEALTHCARE PROVIDER (HCP) CONTINUED TO DEPLOY MORE LENGTH, INCREASE TENSION APPROPRIATELY, AND THE STENT TIP WAS FLARED, BUT STILL NOT FULLY OPENED. HCP TRIED TO COMPLETELY RETRIEVE THE STENT INTO THE PHENOM AND DEPLOY THE TIP END AGAIN. IT WAS FOUND THAT THE STENT TIP END STILL COULD NOT OPEN, AND THERE WAS A POSSIBILITY THAT THE TIP END WAS DAMAGED, SO THE STENT WAS RETRIEVED AGAIN AND WITHDRAWN FROM THE BODY AS A WHOLE WITH THE PHENOM27. HCP REPLACED IT WITH THE NEW PHENOM27 CATHETER AND PED2 STENT, AND THE OPERATION WAS SUCCESSFULLY COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193101 ↗
• MalfunctionJun 11, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP END HAD Y-SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184213 ↗
• MalfunctionJun 9, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON USED A DENSE MESH STENT (PED2-500-20) TO TREAT THE ANEURYSM. THE STENT WAS DELIVERED AFTER THE STENT CATHETER REACHED BEYOND M1 AND DEPLOYED IN THE STRAIGHT SECTION. THE STENT TIP FAILED TO OPEN NORMALLY. THE SURGEON TRIED MANY TIMES AND DEPLOYED IT TO A SUFFICIENT DISTANCE BUT STILL FAILED TO OPEN. THE SURGEON THEN WITHDREW THE STENT AND THE STENT MICROCATHETER AS A WHOLE FROM THE BODY. THE STENT WAS PUSHED OUT OF THE BODY AND OPENED NORMALLY. AT THIS TIME, THE STENT MICROCATHETER COULD NOT BE DELIVERED NORMALLY. AFTER THE MICROCATHETER WAS REPLACED AND DELIVERED TO THE RIGHT PLACE, THE STENT WAS DELIVERED AGAIN TO COMPLETE THE OPERATION. THE CATHETER WAS KINKED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT OPHTHALMIC ARTERY ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 8.1 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169984 ↗
• MalfunctionMay 2, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINE EMBOLIZATION DEVICES FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 1.6 MM AND UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4MM DISTALLY AND 5MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THEY DID NOT TAKE PRU TEST PRIOR TO PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THREE (3) DIFFERENT PIPELINE FLEX WITH SHIELD DEVICES (PED2-500-16, PED2-500-12, PED2-500-20), AND ALL 3 DEVICES FORMED A TRUMPET AT THE DISTAL END OF THE DEVICE AND WOULD NOT OPEN ALL OF THE WAY. THE PROXIMAL END OF ALL 3 DEVICES WOULD OPEN. THEY WERE NOT COMFORTABLE DEPLOYING ANY OF THE DEVICES BECAUSE THE DISTAL END OF THE DEVICE WOULD NOT FULLY OPEN PROPERLY. THEY DECIDED TO PULL ALL DEVICES OUT OF THE PATIENT AND BRING THE PATIENT BACK FOR A DIFFERENT DEVICE. THE PIPELINES WERE NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINES WERE DEPLOYED WHEN THEY FAILED TO OPEN AND THEY WERE RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953515 ↗
• MalfunctionApr 30, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, AN UNRUPTURED ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY WITH SACCULAR MORPHOLOGY AND MODERATELY TORTUOUS VASCULAR ANATOMY WAS BEING TREATED USING A PIPELINE EMBOLIZATION DEVICE 5.00MM X 20MM. THE DISTAL PORTION OF THE PIPELINE DEVICE FAILED TO OPEN DESPITE BEING PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE AND ADVANCED INTO A STRAIGHT SEGMENT OF THE M1 SEGMENT (ENCOUNTERED RESISTANCE). THE DEVICE WAS REMOVED FROM THE PATIENT AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO DEPLOY IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THERE WERE NO ANY ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. IT WAS UNKNOWN IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934414 ↗
• MalfunctionMar 10, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SPECIFIC CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS THOUGHT THAT IT WAS NOT A PROBLEM WITH THE OPERATION, BUT WITH THE STENT ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562818 ↗
• MalfunctionFeb 18, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TIP END FAILED TO OPEN, AND THE TIP END WAS DAMAGED WHEN REMOVED FROM THE BODY. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. AFTER RETRIEVAL, IT WAS ADJUSTED AGAIN AND COULD NOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399184 ↗

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-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