PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00763000284756), received between Aug 11, 2021 and Apr 15, 2026 — classified as 2 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (39 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT WITH A MAX DIA METER OF 10MM AND A 7MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 4.3MM DISTAL AND 5.1MM PROXIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH A NORMAL LEVEL OF PLATELET REACTIVITY UNITS (PRU). THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS AN, "OPHTHALMIC SEGMENT ANEURYSM." NO IMAGES ARE AVAILABLE FOR REVIEW. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER ROUTINE ACCESS WAS ESTABLISHED, THE STENT WAS ADVANCED, WITH THE PLAN TO OPEN THE TIP END OF THE STENT IN THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY. FOLLOWING STANDARD TECHNIQUE, THE OPERATOR RETRACTED THE MARKSMAN MICROCATHETER TO EXPOSE APPROXIMATELY 10 MM OF THE TIP END OF THE STENT. THE TIP END OF THE STENT FAILED TO OPEN AUTOMATICALLY. THE OPERATOR ADVANCED THE SYSTEM TO APPLY TENSION, BUT THE STENT STILL FAILED TO OPEN. REPEATED MANEUVERS WERE UNSUCCESSFUL. IT WAS NOTED THAT THE FAILURE TO OPEN WAS IN THE DISTAL SECTION OF THE DEVICE. THE PIPELINE WAS NOT POSITIONED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884865 ↗
• MalfunctionApr 6, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT NO CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN WERE IDENTIFIED. THE PI PELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790111 ↗
• MalfunctionJan 9, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE PIPELINE FAILURE TO OPEN/RECAPTURE WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. THE PHENOM 27 MICROCATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020142 ↗
• MalfunctionDec 17, 2025No Apparent Adverse Event; Activation Failure; No Apparent Adverse Event; Activation Failure

  THIS REPORT WAS CANCELLED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EVENT DID NOT EXIST, IT WAS A FALSE REPORT. THIS REPORT WAS THEREFORE INVALID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826767 ↗
• MalfunctionDec 3, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS (PED2) DISTAL END FAILED TO OPEN AT THE DISTAL LANDING ZONE. THE FIRST PED2 WAS REPLACED BY THE SECOND ONE. THE PIPELINES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE SAME ISSUE OCCURRED WITH BOTH DEVICES SO THE PROCEDURE WAS STOPPED. THE OUTCOME WAS THOUGHT TO BE THE RESULT OF SEVERE TORTUOSITY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT CAVERNOUS ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS 49. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE FIRST PIPELINE (PED2-500-35) WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL) AND THE SECOND PIPELINE (PED2-500-30) WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE DISTAL PORTION OF THE PIPELINE STENTS WERE POSITIONED IN A BEND, HAD BEEN DEPLOYED MORE THAN 50% WHEN THEY FAILED

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707433 ↗
• MalfunctionNov 18, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2) DISTAL END FAILED TO OPEN. RESHEATHING WAS PERFORMED, AND REDEPLOYMENT WAS ATTEMPTED, HOWEVER, AFTER MORE THAN 50 PERCENT OF THE STENT WAS DEPLOYED, THE DISTAL END WAS NOT OPENING CORRECTLY. THE DISTAL END OF THE PED2 WAS DESCRIBED "LOOKED FUNKY" AND WAS NOT OPENING SO IT WAS REMOVED THROUGH THE MICROCATHETER AFTER MULTIPLE MOVEMENTS WERE PERFORMED TO TRY AND OPEN THE STENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM. THE REPORTED DEVICE AND ANY AC CESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE PIPELINE WAS NOT POSITIONED IN A BEND, WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES, AND THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. ANCILLARY DEVICES INCLUDED PENUMBRA NEURON MAX 6F 088 SHEATH (MODEL PNML6F088904), MEDTRONIC PHENOM PLUS GUIDECATHETER FG19120-1030-1S (LOT 231700075), MEDTRON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585666 ↗
• MalfunctionOct 28, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE DENSE MESH STENT WAS USED TO TREAT AN ANEURYSM, THE STENT TIP WAS IN A ROD SHAPE. AFTER MULTIPLE ATTEMPTS, THE STENT STILL COULD NOT BE OPENED. AFTER WITHDRAWING THE SYSTEM, THE STENT WAS STUCK IN THE PHENOM27 HUB PORT AND COULD NOT BE WITHDRAWN. A NEW STENT AND MICROCATHETER WERE REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT IS ALIVE WITH NO INJURY. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT THE PATIENT WAS UNDERGOING SURGERY DENSE MESH STENT TREATMENT FOR ANEURYSM FOR TREATMENT OF A SACCULAR, UNRUPTURED C7 ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 7 MM NECK DIAMETER. THE LANDING ZONE WAS 5.1 MM DISTALLY AND 4.95MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS BLOOD VESSEL PATENCY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.0 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405771 ↗
• MalfunctionOct 27, 2025Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN AND THE STENT DAMAGE WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED DURING DELIVERY, BUT THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR DEVICES WERE USED TO ATTEMPT TO OPEN THE PIPELINE, AND NO FURTHER TREATMENT WAS TAKEN. IT WAS UNKNOWN IF THERE WAS ANY ALLEGATION AGAINST THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391498 ↗
• MalfunctionAug 13, 2025Collapse; Positioning Failure; Unintended Ejection; Activation, Positioning or Separation Problem; Material Deformation; Activation Failure; Collapse; Positioning Failure; Unintended Ejection; Activation, Positioning or Separation Problem; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED VESSEL TORTUOSITY WAS NORMAL. THE PIPELINE WAS SLOW TO OPEN DISTALLY. PHYSICIAN REPORTED THIS WAS NOT UNEXPECTED GIVEN THE SIZE OF THE DEVICE. THE CATHETER WAS A PHENOM27 CATHETER. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION. IT SHIFTED PROXIMALLY SLIGHTLY DURING RECAPTURE ATTEMPT BUT NOT SIGNIFICANTLY. THE TIP OF THE MICROCATHETER HAS TO MOVE TO DEPLOY THE DEVICE. A DISTAL PORTION AND A MIDDLE PORTION DID NOT OPEN. THE PIPELINE DISTAL DEPLOYMENT WAS A STRAIGHT SEGMENT. THERE WAS NO ISSUE WITH A NAVIEN CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797646 ↗
• MalfunctionAug 8, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY INTRACRANIAL ANEURYSM WITH A MAX DIAMETER OF 7 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. THE LANDING ZONE WAS 4.5MM DISTALLY AND 4.8MM PROXIMALLY. IT WAS REPORTED THAT DURING THE OPERATION, THE DISTAL END OF THE PIPELINE PED STENT COULD NOT BE OPENED. AFTER ATTEMPTING TO RETRIEVE, PUSH AND PULL, IT STILL COULD NOT BE OPENED. THE STENT WAS NOT PLACED IN THE TORTUOUS PART OF THE BLOOD VESSEL. AFTER REPLACING THE STENT, THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS SAFE AND THE REASON WHY THE STENT DID NOT OPEN COULD NOT BE DETERMINED. 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 ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751836 ↗
• MalfunctionJul 7, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING THE STENT DEPLOY PROCESS, THE STENT TIP END COULD NOT BE OPENED. 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 A SACCULAR, UNRUPTURED LEFT INTRACRANIAL ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 6MM NECK DIAMETER. LANDING ZONE: DISTAL: 4MM AND PROXIMAL: 5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 6MM DIAMETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH UNKNOWN PRU LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AN INTERNAL CAROTID ARTERY ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414154 ↗
• MalfunctionJun 16, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING AN ANEURYSM SURGERY, THE PED'S TIP OPENED NORMALLY, BUT THE MIDSECTION FAILED TO OPEN. DESPITE REPEATED ATTEMPTS BY THE SURGEON, THE MIDSECTION REMAINED CLOSED. A NEW PED WAS USED TO CONTINUE THE PROCEDURE, AND THE PATIENT EXPERIENCED NO COMPLICATIONS. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 10 MM AND A 9.2 MM NECK DIAMETER. THE LANDING ZONE WAS 4.8 MM DISTAL AND 5.1 MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213067 ↗
• MalfunctionJun 6, 2025Retraction Problem; Retraction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE PUSHWIRE AND CAPTURE COIL GETTING STUCK WAS THE SLEEVES WEREN¿T ABLE TO BE PULLED THROUGH INTO THE MICROCATHETER. BUNCHED UP AND PUT TO MUCH PRESSURE ON THE END OF THE MICROCATHETER. THE CAPTURE COIL WAS PULLED AS CLOSE TO THE MICROCATHETER AS POSSIBLE AND THE MICROCATHETER AND CAPTURE COIL WERE PULLED OUT TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155889 ↗
• MalfunctionMay 19, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING TREATMENT OF AN AMORPHOUS, UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 8 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.5MM DISTALLY AND 5MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS 112. IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, THE MID-SECTION OF THE PIPELINE WOULD NOT OPEN DESPITE ALL TROUBLESHOOTING/MANEUVERS TO GET THE 5MM DEVICE OPEN. THE PIPELINE WAS POSITIONED IN A BEND MIDDLE SECTION. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). ONCE 5X35 WAS REMOVED AND A NEW DEVICE WAS DEPLOYED, THE ANGIOGRAPHIC FINAL RESULT POST-PROCEDURE WAS GOOD. THE REPORTED DEVICE AND ANY ACCESSORY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046873 ↗
• MalfunctionMay 9, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN AND DAMAGE WAS NOT DETERMINED? IF SO, PLEASE CLARIFY WHAT THE CAUSE WAS. THE PIPELINE WAS IN THE STRAIGHT SECTION OF THE BLOOD VESSEL WHEN IT FAILED TO OPEN. SEVERAL OPERATIONS WERE ATTEMPTED DURING THE SURGERY TO OPEN THE DEVICE, SUCH AS WAITING FOR A WHILE, DEPLOYING A LONGER LENGTH, RETRIEVING THE STENT AND DEPLOYING IT AGAIN, BUT THE PIPELINE STILL DID NOT OPEN. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996946 ↗
• MalfunctionMay 1, 2025Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PIPELINE FAILURE WAS NOT DETERMINED. MULTIPLE PIPELINE DEVICES WERE NOT BEING USED WHEN MOVEMENT OCCURRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING AND IT WAS NOTED THAT EVERYTHING WAS NORMAL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER MOVED DURING THE DEPLOYMENT PROCESS, BUT NO ABNORMAL MOVEMENT OCCURRED. DURING THE PROCESS OF RELEASING THE PIPELINE, THE PROXIMAL END ALWAYS COULD NOT BE OPENED. THE SURGEON TRIED A SERIES OF OPERATIONS: DEPLOYING THE PIPELINE FOR A LONGER DISTANCE, OVERALL REDUCING AND INCREASING TENSION, REPEATEDLY PUSHING AND PULLING, SWINGING, AND RETRIEVING THE STENT AND DEPLOYING IT AGAIN, BUT NONE OF THEM COULD OPEN THE PROXIMAL END OF THE PIPELINE. THEREFORE, THE PIPELINE HAD TO BE COMPLETELY REMOVED FROM THE BODY. BECAUSE THERE WAS ONLY ONE PED2-500-35 IN STOCK IN THE HOSPITAL, A DOMESTIC COMPETITOR'S BLOOD FLOW-GUIDED DENSE MESH STENT HAD TO BE USED. THE OPERATION WAS SUCCESSFULLY COMPLETED AND THE COMPLAINT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942143 ↗
• MalfunctionMar 14, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WAS NO DEVICE ISSUE WITH THE PHENOM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606038 ↗
• MalfunctionJan 7, 2025Unintended Ejection; Structural Problem; Activation, Positioning or Separation Problem; Material Deformation; Unintended Movement; Migration; Unintended Ejection; Structural Problem; Activation, Positioning or Separation Problem; Material Deformation; Unintended Movement; Migration

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, SEVERAL COMPLICATIONS OCCURRED. THE PATIENT EXPERIENCED A CAROTID DISSECTION AND AN ISCHEMIC STROKE, WITH THE DISSECTION LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (LICA). A CORONARY STENT WAS INITIALLY USED FOR RADIAL FORCE BUT WAS DAMAGED (MANGLED) WHEN ATTEMPTING TO REACCESS THE VESSEL DISTALLY. THE DEVICE REPORTEDLY CAME OFF THE DELIVERY WIRE PREMATURELY, LEADING TO THE PLACEMENT OF AN ADDITIONAL PIPELINE. MIGRATION OF THE DEVICE PROXIMALLY WAS NOTED, NECESSITATING THE PLACEMENT OF ANOTHER DEVICE FOR BETTER COVERAGE. BOTH PIPELINES WERE CONFIRMED TO BE PATENT. THE PROCEDURE WAS PERFORMED FOR A CERVICAL CAROTID DISSECTION, WHICH WAS AN OFF-LABEL USE OF THE DEVICE. THE ANGIOGRAPHIC RESULT POST-PROCEDURE INDICATED THAT AN ADDITIONAL PIPELINE WAS PLACED FOR BETTER COVERAGE.

  Patient problems: Failure of Implant

  MAUDE report 21092228 ↗
• MalfunctionDec 3, 2024Unintended Ejection; Activation Failure; Unintended Ejection; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD BEEN DEPLOYED IN THE PHENOM 27 MICROCATHETER. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK DURING DEPLOYMENT. THE DISTAL OF THE PIPELINE COULD NOT BE OPENED. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL OPERATIONS WERE ATTEMPTED TO OPEN THE DEVICE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835147 ↗
• MalfunctionNov 21, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING AN ANEURYSM DENSE MESH STENT IMPLANTATION PROCEDURE FOR A SIDE WALL ANEURYSM OF THE C6 OPHTHALMIC ARTERY SEGMENT, A PIPELINE EMBOLIZATION DEVICE WAS USED. THE ANEURYSM WAS UNRUPTURED, SACCULAR, WITH A DIAMETER OF 5MM AND A NECK DIAMETER OF 4.7MM. LANDING ZONE: DISTAL: 4.2 MM AND PROXIMAL: 4.5 MM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 7 MM. THE PROCEDURE WAS COMPLICATED BY SEVERE VESSEL TORTUOSITY. DURING THE DEPLOYMENT OF THE STENT AT THE M1 STRAIGHT SEGMENT, THE DISTAL END OF THE PIPELINE STENT COULD NOT BE OPENED WELL AND REMAINED UMBRELLA-SHAPED. DESPITE WAITING AND ATTEMPTING RETRIEVAL AND REDEPLOYMENT, THE ISSUE PERSISTED. IT WAS SUSPECTED THAT THE DISTAL END OF THE STENT MIGHT HAVE BEEN DAMAGED. THE SURGEON THEN ATTEMPTED TO OPEN THE STENT AT THE DISTAL END OF C7, BUT THE PROBLEM CONTINUED. CONSEQUENTLY, THE DECISION WAS MADE TO SWITCH TO A DIFFERENT STENT MODEL, PED2-5-30, WHICH WAS SUCCESSFULLY DEPLOYED ACCORDING TO THE STANDARD PROCEDURE, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ANGIOGRAPHIC RESULTS POST-PROCEDURE WERE REPORTED AS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746682 ↗
• MalfunctionAug 26, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE BASILAR ARTERY WITH A MAX DIAMETER OF 7MM AND A 5.2MM NECK DIAMETER. THE LANDING ZONE WAS 4.7MM DISTALLY AND 5.0MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT DURING THE ANEURYSM SURGERY, THE PED TIP COULD NOT BE OPENED. LATER, ANOTHER FD WAS USED AND THE PATIENT WAS FINE. 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 ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063588 ↗
• MalfunctionAug 9, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE DISTAL TIP END WAS THE SECTION OF THE PIPELINE THAT DID NOT OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. IT WAS REPORTED THAT THERE WERE ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948638 ↗
• MalfunctionJul 22, 2024Device Dislodged or Dislocated; Activation Failure; Physical Resistance/Sticking; Device Dislodged or Dislocated; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE APPEARED AT THE DISTAL END OF THE CATHETER. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. THE MIDDLE SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE HAD BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794315 ↗
• MalfunctionJul 22, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE PUSHWIRE BREAK WAS NOT DETERMINED, IT JUST BROKE WHEN THE PIPELINE WAS BEING RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791685 ↗
• MalfunctionJul 16, 2024Degraded; Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Degraded; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR CERVICAL ICA DISSECTION. LANDING ZONE (ARTERY SIZE): DISTAL 4 MM AND PROXIMAL 4 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. THE DEVICE WOULD NOT OPEN ON THE DISTAL PORTION. THE PHYSICIAN COULD GET THE MID AND PROXIMAL SECTIONS OPEN BUT NOT THE DISTAL SECTION. THE PIPELINE LOOKED PINCHED ON ANGIO SO THEY DECIDED TO REMOVE THE DEVICE. A SECOND PIPELINE WAS PREPARED PER THE IFU AND WAS DEPLOYED IN THE PATIENT. THE PIPELINE USED FOR AN INDICATION THAT IS NOT APPROVED (CAROTID DISSECTION). THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NONE OF THE TECHNIQUES WOULD OPEN WHILE STILL BEING ABLE TO RESHEATH. THE PIPELINE WAS REMOVED FROM THE PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED (PRU LEVEL NOT CHECKED). ANGIOGRAPHIC RESULT POST PROCEDURE: SECOND DEVICE DEPLOYED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752609 ↗

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-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-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-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• 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-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-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