PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00763000284749), received between Aug 11, 2021 and Feb 9, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT NO DAMAGE WAS IDENTIFIED ON EITHER THE PIPELINE OR THE PHENOM. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PIPELINE FAILURE TO OPEN IN THE DISTAL END OF THE DEVICE. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. MULTIPLE ADDITIONAL STEPS WERE TAKEN IN ATTEMPT TO OPEN THE PIPELINE DEVICE LIKE RETRIEVAL AND PUSH-PULL MANEUVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291972 ↗
• MalfunctionJan 20, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 25 MM AND A 40 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 8MM DIAMETER. THE LANDING ZONE WAS 4MM DISTALLY AND 4.8MM PROXIMALLY.  IT WAS UNKNOWN IF A DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED.  THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD.  IT WAS REPORTED THAT THIS CASE INVOLVED A BRIDGING PROCEDURE. THE FIRST STENT, PED2 (4.75-30), WAS SUCCESSFULLY DEPLOYED AT THE DISTAL END OF THE INTERNAL CAROTID ARTERY. THE SECOND STENT, PED2 (5-30), WAS ADVANCED THROUGH THE FIRST STENT AND REACHED THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY. ATTEMPTS WERE MADE TO OPEN THE STENT, BUT AFTER DEPLOYMENT, THE DISTAL END OF THE STENT PRESENTED A Y-SHAPE. FURTHER DEPLOYMENT OF THE STENT UP TO 12.3MM STILL FAILED TO OPEN IT. THE DECISION WAS MADE TO RETRACT IT TO THE INTERNAL CAROTID ARTERY (WITHIN THE FIRST STENT) AND POSITION IT 15MM FROM THE DISTAL END OF THE BRIDGING STENT. OSCILLATORY MANEUVERS WERE PERFORMED, BUT THE STENT DISPLAYED A Y-SHAPE AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117931 ↗
• 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 23707447 ↗
• 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 23498680 ↗
• MalfunctionOct 17, 2025Material Frayed; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Retraction Problem; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. SOME RESISTANCE WAS ENCOUNTERED DURING DELIVERY OF THE PIPELINE, PARTICULARLY AFTER SEVERAL RE- SHEATHINGS. THE MODEL AND LOT NUMBER OF THE PHENOM 27 MICROCATHETER USED ARE UNKNOWN. POSSIBLE FRAYING WAS OBSERVED AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323175 ↗
• MalfunctionOct 15, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM OF THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. A MINIMALLY INVASIVE NEUROINTERVENTIONAL PROCEDURE WAS PERFORMED, WITH IMPLANTATION OF A DENSE MESH FLOW-DIVERTING STENT. FEMORAL ARTERY PUNCTURE WAS PERFORMED, AND A 6F LONG SHEATH WAS SUCCESSFULLY ADVANCED TO THE COMMON CAROTID ARTERY WITH THE ASSISTANCE OF A 0.035-INCH LOACH GUIDEWIRE AND A 125 MULTIFUNCTIONAL ANGIOGRAPHIC CATHETER. A 6F 115 CM INTERMEDIATE CATHETER WAS FURTHER ADVANCED TO THE CAVERNOUS SINUS SEGMENT, AND THE PHENOM27, GUIDED BY A 0.014-INCH SYNCHRO GUIDEWIRE, WAS SMOOTHLY NAVIGATED TO THE M1 AND M2 SEGMENTS. BASED ON 3D MEASUREMENTS, A PED2-500-30 WAS SELECTED. AFTER ADEQUATE HYDRATION WITH HIGH-PRESSURE NORMAL SALINE, THE STENT WAS SMOOTHLY DELIVERED TO THE DISTAL SITE. THE STRAIGHT SEGMENT OF THE M1 MIDDLE CEREBRAL ARTERY WAS CHOSEN FOR EXPOSURE OF THE TIP, BUT THE STENT'S TIP COULD NOT BE OPENED. DEPLOYMENT CONTINUED OVER A LONGER DISTANCE, BUT EVEN AFTER APPROXIMATELY 10 MM, IT STILL COULD NOT BE OPENED. AFTER RETRIEVED AND REDEPLOYED, IT STILL COULD NOT BE OPENED. FURTHER DEPLOYED OVER A LONGER DISTANCE, THE MIDSECTION OF THE STENT OP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304517 ↗
• MalfunctionJul 22, 2025Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED; ONLY THE MARKSMAN CATHETER WAS USED FOR THIS EVENT. THE CAUSE OF THE DEPLOYMENT FAILURE WAS STENT TIP DAMAGE. IT WAS UNKNOWN THE EXACT PART OF THE CATHETER ENCOUNTERED RESISTANCE. AFTER REMOVAL, A STRETCHING WAS OBSERVED AT THE CATHETER TIP, AND THE BRAIDED WIRES AT THE STENT TIP APPEARED FRAYED. THE PIPELINE FAILED TO OPEN AT THE DISTAL END, AND THE PIPELINE WAS NOT DEPLOYED IN A VESSEL BEND WHEN THE FAILURE OCCURRED. RE-SHEATHING, STENT RETRIEVAL, AND FORCED DEPLOYMENT STEPS WERE ATTEMPTED TO OPEN THE PIPELINE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568168 ↗
• MalfunctionJul 7, 2025Activation Failure; Activation Failure

  (B)(6) 2025 MPXR 1319575 (REP, HCP, FOR): MEDTRONIC RECEIVED A REPORT THAT DURING THE STENT DEPLOYMENT PROCESS, THE TIP END COULD NOT BE OPENED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 6MM NECK DIAMETER. LANDING ZONE: DISTAL: 4MM AND PROXIMAL: 4MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH UNKNOWN PRU LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AN INTRACRANIAL ANEURYSM. (B)(6) 2025 E1, ARED (REP, HCP, FOR): ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER STENT. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. IT WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. TRIED OTHER STEPS OR OTHER DEVICES TO OPEN THE PIPELINE (RETRIEVING, PUSHING, PULLING, ETC.).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414995 ↗
• MalfunctionJul 7, 2025Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413764 ↗
• MalfunctionDec 5, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE SHIELD STENT THAT FAILED TO OPEN AT THE DISTAL END AND WAS DAMAGED. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A LEFT VERTEBRAL ARTERY V4 SEGMENT UNRUPTURED FUSIFORM ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6.7MM AND THE NECK DIAMETER WAS 4.1MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED; PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS FLUSHED AND DELIVERED THROUGH MICROCATHETER FOR DEPLOYMENT. WHEN MORE ABOUT 15MM AND OF THE PIPELINE STENT WAS PUSHED OUT, IT WAS OBSERVED THAT THE DISTAL TIP WAS NOT OPENING. REPEATED ATTEMPTS TO RETRIEVE AND REDEPLOY DID NOT OPEN THE STENT EVEN WITH MORE THAN 50% OF THE STENT DEPLOYED. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND AND NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. BECAUSE OF THE FAILURE TO OPEN DESPITE REPEATED ATTEMPTS, THE PIPELINE WAS REMOVED AND THE DOCTOR DEPLOYED AND MASSAGED THE END WHICH DID OPEN BUT WAS FOUND THAT THE TIP WAS DAMAGED. THE PHYSICIAN THEN USED ANOTHER MANUFAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856729 ↗
• MalfunctionOct 16, 2024Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463297 ↗
• MalfunctionAug 9, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE SHIELD STENT THAT FAILED TO OPEN.  THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN M1 SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS NOTED THAT DUAL ANTIPLATELET TREATMENT WAS NOT ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE FAILED TO OPEN AT THE DISTAL END WHEN LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESEHEATHED AND REMOVED WITH THE MICROCATHETER.  ANCILLARY DEVICES: 8F TERUMO SHEATH, WALLANT 6F 088 GUIDE CATHETER, PHENOM 27 MICROCATHETER, HYBRID 014 GUIDEWIRE, PHENOM PLUS CATHETER THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY SHOWED SATISFACTORY REDIRECTED BLOOD FLOW FROM THE ANEURYSM. THE EVENT DID NOT LEAD TO OR PROLONG THE PATIENT'S HOSPITALIZATION. NO ADDITIONAL MEDICATION OR SURGICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT PATIENT IMPAIRMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950656 ↗
• MalfunctionJul 11, 2024Stretched; Material Deformation; Activation Failure; Stretched; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT SEVEN PIPELINES FAILED TO OPEN DISTALLY AND BECAME STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE LANDING ZONE WAS 4MM DISTAL AND 5MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS SAID TO BE 80. IT WAS REPORTED THAT THE PHYSICIAN TRIED WITH MULTIPLE PIPELINES IN VARIOUS SIZES, BUT THE SEVERE TORTUOSITY WAS CAUSING THE DEVICES TO STRETCH AND BE UNABLE TO DEPLOY TO THE PHYSICIAN'S STANDARD. THEY WERE FINALLY ABLE TO OPEN A PIPELINE DISTALLY AND DRAG IT INTO PLACE, ALLOWING FOR THE DEVICE TO OPEN AND TREAT THE PATIENT SUCCESSFULLY. THE ENTIRETY OF THE PIPELINES HAD BEEN PLACED IN A BEND WHEN THEY FAILED TO OPEN. THE PIPELINES HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICES. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THE LAST 4 PIPELINES FAILED TO OPEN. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE PATIENT WAS TREAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721778 ↗
• MalfunctionJun 3, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN. TIP END COULD NOT BE OPENED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, AMORPOUS ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS 4.4MM AND THE PROXIMAL LANDING ZONE WAS 4.9MM. VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS THE STENT WAS WELL ATTACHED TO THE WALL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19452887 ↗
• MalfunctionJun 3, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN OPHTHALMIC ARTERY C6 SEGMENT LATERAL WALL ANEURYSM, WITH THE ANEURYSM INVOLVING THE C5-C6 SEGMENT. THE SURGEON DELIVERED THE P27 STENT CATHETER THROUGH THE LESION AND RELEASED THE STENT ACCORDING TO THE STANDARD PROCEDURE. THEN TRIED TO OPEN THE DISTAL OF THE STENT IN THE M1 STRAIGHT SEGMENT, BUT THE DISTAL END COULD NOT BE OPENED SMOOTHLY AFTER SEVERAL ATTEMPTS. AFTER A FEW MINUTES OF WAITING AND RETRIEVING AND RELEASING AGAIN, THE DISTAL END STILL COULD NOT BE OPENED NORMALLY. A NEW PED2 4.75-30 WAS THEN REPLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM IN THE C6 OPHTHALMIC ARTERY LATERAL WALL WITH A MAX DIAMETER OF 10MM AND A 6MM NECK DIAMETER. LANDING ZONE WAS 4.2MM DISTALLY AND 5MM PROXIMALLY. ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. ANCILLARY DEVICES INCLUDE ASHENRUIDA MICROCATHETER AND STRYKER GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447595 ↗
• MalfunctionApr 10, 2024Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PHYSICIAN PUSHED THE STENT OUT OF THE SHEATH IN A BASIN BEFORE FLUSHING. THE PHYSICIAN ATTEMPTED TO DEPLOY 3 PIPELINES ON A GIANT, WIDE NECK CAVERNOUS ICA ANEURYSM. THE DEVICES WOULD NOT OPEN DISTALLY. OVER HALF OF THE DEVICES WERE DEPLOYED AND THE DISTAL END WAS FISH- MOUTHED SO THE PHYSICIAN RECAPTURED AND REMOVED EACH ONE. A FINAL DEVICE WAS SUCCESSFULLY DEPLOYED WITH A GOOD FINAL ANGIOGRAPHIC RESULT. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. BALLOON ANGIOPLASTY WAS REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: GUIDE CATHETER PENUMBRA BENCHMARK (B)(6) LOT# F00009874, MICROCATHETER PHENOM 27 FG15150-0615-1S LOT# 227802043, GUIDEWIRE TRANSEND (B)(6) LOT# 31577966 ACTIVATION PROBLEM_FAILURE/INCOMPLETE TO OPEN_AT DISTAL ACTIVATION PROBLEM_FAILURE/INCOMPLETE TO OPEN_FISHMOUTH DURING DEPLOYMENT DURING DEPLOYMENT ACTIVATION PROBLEM_ADJUNCTIVE ASSISTANCE NO CLINICAL SIGNS, SYMPTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080633 ↗
• MalfunctionJan 9, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE DID OPEN, THEN TWISTED. THE SITE WAS QUERIED TO CLARIFY IF THERE WAS ANY DEVICE DEFICIENCIES WITH RIST CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479829 ↗
• MalfunctionSep 19, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED2 PIPELINES FAILED TO OPEN IN THE DISTAL SECTION. THE HEALTHCARE PROVIDER (HCP) PLACED THE PIPELINE THROUGH THE PHENOM 27 DISTAL TO THE ANEURYSM. ONCE HE STARTED TO TRY AND GET THE STENT TO OPEN UP, HE COULD NOT GET IT OPEN. HE RE-SHEATHED MULTIPLE TIMES AND WAS UNSUCCESSFUL. HE PULLED THE DEVICE FROM THE PATIENT AND NOTICED THAT THE DISTAL TIP OF THE PIPELINE WAS STRETCHED/FRAYED/DAMAGED. HE PULLED A 2ND PIPELINE AND THE EXACT SAME THING HAPPENED. HE WAS SUCCESSFUL WITH THE 3RD PIPELINE. THE PIPELINES WERE NOT POSITIONED IN A BEND. THEY WERE NOT STUCK IN THE CAPTURE COIL. LESS THAN 50% HAD BEEN DEPLOYED WHEN THEY FAILED TO OPEN. THEY WERE RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS 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, SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). VESSEL TORTUOUSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: CERABASE GUIDE CATHETER, PHENOM27 MICROCATHETER, NAVIEN .058X125CM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770602 ↗
• MalfunctionDec 12, 2022Positioning Failure; Activation, Positioning or Separation Problem; Unintended Movement; Migration; Positioning Failure; Activation, Positioning or Separation Problem; Unintended Movement; Migration

  MEDTRONIC RECEIVED A REPORT REGARDING PIPELINE (LOT # B376652)  DIFFICULT PLACEMENT/POSITIONING AND PIPELINE (LOT # B375979 AND LOT# UNKNOWN) FAILURE TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE CAVERNOUS WITH A MAX DIAMETER OF 2.5MM AND A 15MM NECK DIAMETER. THE LANDING ZONE WAS 4MM DISTALLY AND 5MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS 100. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE PIPELINE WAS NOT COVERING THE PROXIMAL NECK, BUT STILL HAD GOOD FLOW. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   IT WAS REPORTED THAT TWO DEVICES WERE PULLED OUT AS DISTAL END WOULD NOT OPEN AS DESIRED. THE THIRD DEVICE WAS IMPLANTED BUT END RESULT WAS IT PUSHED INTO PROXIMAL ANEURYSM AND COULD NOT RE-ACCESS OR SNARE OUT. PATIENT IS STABLE AND GOOD FLOW THRU THE VESSEL AT THIS TIME. IT WAS REPORTED FOR PIPELINE (LOT # B376652) THAT WHILE ATTEMPTING TO BALLOON PIPELINE - PROXIMAL END OF PIPELINE FORESHORTENED ABOUT 10 MM AND PUSHED INTO PROXIMAL END OF ANEURYSM. WHICH COULD NOT BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964340 ↗
• MalfunctionNov 21, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING PIPELINE (LOT # B376652)  DIFFICULT PLACEMENT/POSITIONING AND PIPELINE (LOT # B375979 AND LOT# UNKNOWN) FAILURE TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE CAVERNOUS WITH A MAX DIAMETER OF 2.5MM AND A 15MM NECK DIAMETER. THE LANDING ZONE WAS 4MM DISTALLY AND 5MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS 100. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE PIPELINE WAS NOT COVERING THE PROXIMAL NECK, BUT STILL HAD GOOD FLOW. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   IT WAS REPORTED THAT TWO DEVICES WERE PULLED OUT AS DISTAL END WOULD NOT OPEN AS DESIRED. THE THIRD DEVICE WAS IMPLANTED BUT END RESULT WAS IT PUSHED INTO PROXIMAL ANEURYSM AND COULD NOT RE-ACCESS OR SNARE OUT. PATIENT IS STABLE AND GOOD FLOW THRU THE VESSEL AT THIS TIME. IT WAS REPORTED FOR PIPELINE (LOT # B376652) THAT WHILE ATTEMPTING TO BALLOON PIPELINE - PROXIMAL END OF PIPELINE FORESHORTENED ABOUT 10 MM AND PUSHED INTO PROXIMAL END OF ANEURYSM. WHICH COULD NOT BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838511 ↗
• InjuryApr 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT BEGAN TO EXPERIENCE STROKE-LIKE SYMPTOMS FOLLOWING THE DEVICE DEPLOYMENT DAYS LATER. IMAGING DETERMINED THAT ONE OF THE VERTERBRAL PERFORATORS WAS SHUTTING DOWN DUE TO BEING COVERED BY THE FLOW DIVERTERS. THE PATIENT'S CONDITION WAS UNKNOWN AT THE TIME OF THE REPORT. THE PIPELINE WAS USED OFF-LABEL, AS THE EMBOLIZATION WAS OF THE RIGHT VERTEBRAL FUSIFORM ANEURYSM.

  Patient problems: Stroke/CVA

  MAUDE report 13992539 ↗
• MalfunctionApr 1, 2022Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE WAS DEPLOYED BUT THE PHENOM 27 CATHETER DROPPED AND AFTER RETRYING DEPLOYMENT THE DEVICE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE PARA OPHTHALMIC LOCATION. THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 6MM. THE DISTAL LANDING ZONE WAS 3.56MM. THE PROXIMAL LANDING ZONE WAS 4.78M. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. PRU LEVEL WAS 125.  DURING INITIAL DEPLOYMENT THE DEVICE WAS OPENING GREAT BUT DUE TO TORTUROUS VESSELS THE CATHETER SYSTEM DROPPED CAUSING US TO LOSE ACCESS. AFTER ATTEMPTING TO GET BACK INTO PLACE AND RETRY DEPLOYMENT IT APPEARED THE DEVICE TINES HAD STUCK TOGETHER - WE RESHEATHED TWICE - UNABLE TO GET DEVICE TO OPEN WE ABORTED PROCEDURE. 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. NO ADDITIONAL STEPS REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT WAITH THE MICROCATHETER. WILL TRY AGAIN WITH NEW DEVICE IN A FEW WEEKS. ANGIOGRAPHIC RESULTS POST PROCEDURE WAS NO INJURY.  ANCILLARY DEVICES: 6F TERU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972315 ↗
• MalfunctionNov 30, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 3 PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR AN "ANEURYSM TREATED WITH FRED." IT WAS A RUPTURED ANEURYSM WITHIN THE LEFT INTERNAL CAROTID ARTERY, IN A BLISTER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.   IT WAS REPORTED THAT THEY COULD NOT GET THE DISTAL END OF ALL DEVICES OPENED, TRIED THREE DIFFERENT DEVICES. THE DEVICES WERE NOT PLACED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE RESHEATHED "LESS THAN OR EQUAL TO 2 TIMES." THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINES. THE PIPELINES WERE USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL), IN A RUPTURED BLISTER. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE DEVICES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899586 ↗
• MalfunctionOct 13, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES WOULD NOT OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 7MM. THE LANDING ZONE WAS 4.5MM ON THE DISTAL SIDE AND 4MM ON THE PROXIMAL SIDE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST DEVICE WOULD NOT OPEN DISTALLY REGARDLESS OF SEVERAL ATTEMPTS AND ONE RECAPTURE TO ADJUST THE PTFE SLEEVES. NEW DEVICE (SAME SIZE AND LOT#) WAS OPENED AS WELL AS NEW PHENOM 27. SECOND ATTEMPT RESULTED IN THE SAME OUTCOME. THE DEVICE WOULD NOT FLOWER OR OPEN. DISTAL EDGE OF THE BRAID APPEARED FRAYED UPON OBSERVATION AFTER REMOVAL OF SECOND DEVICE. THE DOCTOR INDICATED THAT POTENTIALLY THE EXTREMELY TORTUOUS ANATOMY CONTRIBUTED TO THE FAILURE OF THE DEVICE TO OPEN. THEY ARE CONSIDERING BRINGING THE PATIENT BACK FOR A FRED FLOW DIVERSION ATTEMPT AS THAT DEVICE MAY OPEN EASIER IN SUCH ANATOMY. 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." THERE WERE NO ADDITIONAL STEPS OR OTHER DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624609 ↗
• MalfunctionSep 9, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES WOULD NOT OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 7MM. THE LANDING ZONE WAS 4.5MM ON THE DISTAL SIDE AND 4MM ON THE PROXIMAL SIDE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST DEVICE WOULD NOT OPEN DISTALLY REGARDLESS OF SEVERAL ATTEMPTS AND ONE RECAPTURE TO ADJUST THE PTFE SLEEVES. NEW DEVICE (SAME SIZE AND LOT#) WAS OPENED AS WELL AS NEW PHENOM 27. SECOND ATTEMPT RESULTED IN THE SAME OUTCOME. THE DEVICE WOULD NOT FLOWER OR OPEN. DISTAL EDGE OF THE BRAID APPEARED FRAYED UPON OBSERVATION AFTER REMOVAL OF SECOND DEVICE. THE DOCTOR INDICATED THAT POTENTIALLY THE EXTREMELY TORTUOUS ANATOMY CONTRIBUTED TO THE FAILURE OF THE DEVICE TO OPEN. THEY ARE CONSIDERING BRINGING THE PATIENT BACK FOR A FRED FLOW DIVERSION ATTEMPT AS THAT DEVICE MAY OPEN EASIER IN SUCH ANATOMY. 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." THERE WERE NO ADDITIONAL STEPS OR OTHER DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447629 ↗

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-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-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-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-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