PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00763000284695), received between Jun 15, 2021 and Feb 12, 2026 — classified as 3 deaths, 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (52 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT A PARAOPHTHALMIC UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM; THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 3.8MM; THE PROXIMAL LANDING ZONE WAS 4.7MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. IT WAS ATTEMPTED TO OPEN MULTIPLE TIMES IN THE STRAIGHT M1 SEGMENT WITHOUT SUCCESS; IT WAS NOT POSITIONED IN A BEND. MORE THAN 70% OF THE PIPELINE WAS DEPLOYED WITHOUT SUCCESSFUL OPENING OF THE DISTAL END THOUGH THE PROXIMAL AND MIDDLE SECTIONS OPENED. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. PUSHING AND LOADING THE MICROCATHETER WAS ATTEMPTED TO POP THE STENT OPEN BUT DID NOT WORK. A SNARE RETRIEVAL DEVICE WAS USED TO RETRIEVE THE PIPELINE AND REMOVE FROM THE PATIENT. THE PIPELINE WAS REPLACED WITH ANOTHER PIPELINE THAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. POST PROCEDURE ANGIOGRAPHIC

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

  MAUDE report 24324076 ↗
• MalfunctionDec 10, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE FAILURE TO OPEN/BIRD'S BEAK BEHAVIOR WAS NOT DETERMINED. THERE WAS A LITTLE FRICTION/DIFFICULTY DURING DELIVERY OR POSITIONING BUT NOTHING OUT OF THE ORDINARY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PUSHERWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774937 ↗
• MalfunctionNov 7, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.9 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.5MM DISTALLY AND 9MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL IT WAS REPORTED THAT DURING DEPLOYMENT , BOTH LARGE SIZED DIAMETER PIPELINES PED STENT WERE VERY DIFFICULT TO OPEN AND WOULD NOT OPEN AT DISTAL END ON BOTH PIPELINE DEVICES. A THIRD PED STENT DEVICE OPEN AND FIT APPROPRIATELY FOR THE PATIENT TO BE TREATED. THE PIPELINE WAS NOT POSITIONED IN A BEND. 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). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501128 ↗
• MalfunctionMay 12, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED2 PIPELINES FAILED TO OPEN IN THE DISTAL SECTION. THE DOCTOR TRIED TO DEPLOY BOTH THE PIPELINE DEVICES PROXIMAL TO ANTERIOR CHOROIDAL ARTERY BUT THE DISTAL END OF THE DEVICE DID NOT OPEN. TRIED ALL THE DIFFERENT RECOMMENDED MANEUVERS BUT NOTHING HELPED. BOTH DEVICES HAD THE SAME ISSUE BUT THEN DOCTOR SWITCHED TO A COMPETITOR PRODUCT AND IT WAS DEPLOYED SUCCESSFULLY. THE PIPELINES WERE NOT POSITIONED IN BENDS. MORE THAN 50% OF THE PIPELINES HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINES. THE PIPELINES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THRE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPUTURED, SACCUALR ANEURYSM IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTUD ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 5MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL LANDING ZONE WAS 4.8MM. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: MIDWAY 43 GUDIE CATHETER, PHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999996 ↗
• MalfunctionApr 18, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, THE DISTAL END OF THE DEVICE WOULD NOT OPEN WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY IT IN THE M1 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY PARA OPHTHALMIC REGION. THE ANEURYSM WAS UNRUPTURED AND SACCULAR WITH A NECK DIAMETER OF 3.12 MILLIMETERS, AND THE VESSEL EXHIBITED MODERATE TORTUOSITY. THE PHYSICIAN RECAPTURED AND ATTEMPTED TO REDEPLOY THE DEVICE, BUT UNDER FLUOROSCOPY, IT APPEARED THAT A PTFE SLEEVE WAS CAUGHT ON THE DISTAL PORTION OF THE BRAID. THE DEVICE AND MICROCATHETER WERE REMOVED FROM THE PATIENT, AND IT WAS CONFIRMED THAT THE PTFE SLEEVE WAS INDEED CAUGHT. ADDITIONALLY, THE TIP COIL FELL OFF WHEN THE PRODUCT WAS PLACED INTO A BIOHAZARD BAG. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ANGIOGRAPHIC RESULT POST-PROCEDURE SHOWED THE DEVICE WAS WELL OPPOSED WITH GOOD STASIS. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES: SHEATH N/A, GUIDE CATHETER VECTA 47, MICROCATHETER PHENOM 27 150CM, GUIDEWIRE 14 WIRE BRAND N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866386 ↗
• InjuryMar 19, 2025Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, A PIPELINE FLEX EMBOLIZATION DEVICE WAS USED TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY. THE TIP OF THE PED2-500-14 DEVICE DID NOT FULLY EXPAND, AND A SUBSEQUENT ATTEMPT WITH THE PED2-500-16 DEVICE ALSO RESULTED IN INCOMPLETE TIP EXPANSION. THE PHYSICIAN ATTEMPTED BALLOON ANGIOPLASTY TO EXPAND THE DEVICE, BUT IT WAS UNSUCCESSFUL. AN ENTERPRISE STENT WAS ULTIMATELY DEPLOYED TO ASSIST IN FULLY OPENING THE PIPELINE, COMPLETING THE PROCEDURE. POST-PROCEDURE, THE PATIENT EXPERIENCED APHASIA AND AN INABILITY TO MOVE THEIR RIGHT HAND. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND ANGIOGRAPHIC RESULTS SHOWED THE FRONT END OF THE PED2-500-14 WAS NOT FULLY EXPANDED. THE PATIENT'S CONDITION IS GRADUALLY IMPROVING.

  Patient problems: Ambulation or Postural Difficulties; Paralysis

  MAUDE report 21645923 ↗
• MalfunctionMar 12, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE'S PTF WINGS FAILED TO OPEN/WOULD NOT FLIP. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. IT WAS REPORTED THAT UPON TRYING TO DEPLOY THE DEVICE OUT OF THE INTRODUCER SHEATH, THE PTF WINGS WOULD NOT RELEASE, "FLIP". EVEN AFTER TRYING TO RESHEATH, THE DEVICE WAS PULLED OUT OF THE PATIENT AND ANOTHER ATTEMPT WAS DONE TO FLIP THE WINGS ON THE BACK TABLE, BUT IT WOULD NOT FLIP. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE STENT WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE. IT WAS REMOVED FROM THE PATIENT AND RESHEATHED WITH THE MICROCATHETER. THE STENT WAS REPLACED WITH A DIFFERENT DEVICE. 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 ASSOCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587668 ↗
• MalfunctionFeb 11, 2025Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT DURING A PIPELINE DEPLOYMENT, THE PIPELINE STENT CAME OFF OF THE RESHEATHING PAD. HEALTHCARE PROVIDER (HCP) PREPPED PIPELINE DEVICE PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED INTO PHENOM 027. PHENOM 027 WAS DISTAL TO THE ANEURYSM AND BEGAN DEPLOYMENT. DURING THE DEPLOYMENT THE STENT CAME OFF THE RESHEATHING PAD WHILE STILL CONSTRAINED BY THE PHENOM 027. HCP WAS ABLE TO REMOVE THE STENT AND THE MICROCATHETER FROM THE PATIENT. A NEW PIPELINE DEVICE WAS PREPPED AND DEPLOYED. THE PATIENT WOKE UP AND SENT TO PACU. NO INJURY FROM THE FAILED PIPELINE DEPLOYMENT. THE PIPELINE WAS USED FOR AN APPROVED 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 LEFT CAVERNOUS CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 10 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE WAS 4.33 MM DISTALLY, AND 4.99 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL 70. ANGIOGRAPH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356688 ↗
• MalfunctionFeb 3, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO PIPELINE EMBOLIZATION DEVICES, THERE WAS A FAILURE TO OPEN THE DISTAL SECTION OF THE DEVICES. THE PATIENT HAD AN UNRUPTURED CEREBRAL ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY, CAVERNOUS SEGMENT, WITH A SACCULAR MORPHOLOGY, MEASURING 10MM IN MAXIMUM DIAMETER AND 5MM IN NECK DIAMETER. THE DISTAL ALNDING ZONE WAS 5.11MM AND THE PROXIMAL LANDING ZONE WAS 4.97MM. THE FIRST DEVICE WAS PREPPED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE MICRO CATHETER SMOOTHLY. THE INITIAL DISTAL TIP COIL WAS UNHEEDED AS WELL AS THE DISTAL 3 TO 5 MM OF DEVICE WAS DEPLOYED IN ORDER TO EXPOSE THE PTFE SLEEVES, AND THEN THE PHENOM 27 WAS ADVANCED BACK TO THE DISTAL MARKER TO PUSH THE PTFE SLEEVES OUT OF THE WAY. FIRST ATTEMPT TO DEPLOY DEVICE ABOUT 1/3 OF THE DEVICE WAS EXPOSED AND DID NOT OPEN SO THE HEALTHCARE PROVIDER (HCP) CHOSE TO RECAPTURE TO THE DISTAL MARKER AND TRY AGAIN BY PUSHING BRAID TO ADVANCE DEVICE. THIS ATTEMPT ABOUT 50% OF THE DEVICE WAS EXPOSED AND AGAIN THE DISTAL AND REMAINED SHUT. HCP CHOSE TO RECAPTURE AGAIN TO THE DISTAL MARKER AND THEN THIRD ATTEMPT DOCTOR EXPOSED 2/3 OF THE DEVICE AND NOTED THE MIDSECTION OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293979 ↗
• MalfunctionDec 6, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING THE PIPELINE EMBOLIZATION DEVICE, THE DISTAL END OF THE PIPELINE DEVICE FAILED TO OPEN ON TWO OCCASIONS. THE DEVICE WAS POSITIONED IN A BEND AT THE MIDDLE SECTION FOR BOTH DEVICES. MORE THAN 50% HAD BEEN DEPLOYED WHEN THE DEVICES FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN TWO TIMES IN BOTH INSTANCES AND SUBSEQUENTLY REMOVED FROM THE PATIENT EACH TIME. THE DOCTOR TRIED "ALL THE TRICKS" TO GET THE DEVICE OPEN AND IT WOULD NOT WORK. THE PROCEDURE WAS COMPLETED BY IMPLANTING A SURPASS FLOW DIVERTER, WHICH RESULTED IN A SATISFACTORY ANGIOGRAPHIC OUTCOME. THE ANEURYSM WAS LOCATED IN THE INTERNAL CAROTID ARTERY, UNRUPTURED, WITH A SACCULAR MORPHOLOGY, A MAXIMUM DIAMETER OF 5.3 MILLIMETERS, AND A NECK DIAMETER OF 2.3 MILLIMETERS. THE LANDING ZONE MEASURED 3.9 MILLIMETERS DISTALLY AND 4.7 MILLIMETERS PROXIMALLY, WITH MODERATE VESSEL TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873217 ↗
• MalfunctionOct 7, 2024Activation Failure; 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 AN UNRUPTURED PARAOPTHALMIC ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 2.5 MM AND NECK DIAMETER 2.5 MM. LANDING ZONE (ARTERY SIZE): DISTAL 3.8 MM AND PROXIMAL 4.8 MM. THE VESSEL TORTUOSITY WAS MINIMAL. THE PHYSICIAN TRIED TO DEPLOY 5.00 X 14 AND 4.75 X 16 IN VESSEL. THE DISTAL END WOULD NOT OPEN AND PHYSICIAN TRIED MULTIPLE RESHEATHS AND REPOSITIONING TO OPEN DISTAL END. BOTH TIMES THE PRODUCTS WERE REMOVED FROM THE CATHETER WITH NO ISSUE. THE PIPELINE WAS POSITIONED IN THE MIDDLE OF THE BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED (PRU LEVEL WAS UNKNOWN). THE ANGIOGRAPHIC RESULT POST PROCEDURE: NO INJURY TO VESSEL OR PATIENT. THERE WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391312 ↗
• 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 TREA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721788 ↗
• DeathFeb 13, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOTED THAT THE PATIENT EXPIRED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18698037 ↗
• DeathFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOTED THAT THE PATIENT EXPIRED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18698034 ↗
• MalfunctionFeb 1, 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 IN THE RIGHT INTERNAL CAROTID ARTERY. LANDING ZONE: DISTAL: 3.68 MM AND PROXIMAL: 4.98 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT PIPELINE WAS PREPPED APPROPRIATELY. UPON ATTEMPTING TO DEPLOY THE DEVICE, THERE APPEARED TO BE A 'RIBBONING' EFFECT AND LACK OF OPENING BETWEEN THE DISTAL AND MIDDLE SECTIONS. RE-SHEATHING, FORWARD PRESSURE ON MICROCATHETER, OPENING A LARGE AMOUNT OF DEVICE, AND LOADING/REDUCING LOAD TECHNIQUES WERE ATTEMPTED WITH NO SUCCESS. AFTER THESE TECHNIQUES FAILED TO OPEN THE SAME AREA OF THE PIPELINE, THE PHYSICIAN REQUESTED ANOTHER PIPELINE OF THE SAME SIZE. HE SUCCESSFULLY REMOVED THE PIPELINE BY RE-SHEATHING VIA THE APPROPRIATE PHENOM 27 CATHETER. THE NEW PIPELINE WAS SUCCESSFULLY DEPLOYED WITH STANDARD TECHNIQUE AND MUCH LESS MANIPULATION. IT WAS REPORTED THE PIPELINE FAILED TO OPEN BETWEEN THE DISTAL AND MIDDLE SEGMENT. THE PIPELINE WAS POSITIONED IN A MIDDLE BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627482 ↗
• MalfunctionDec 20, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369890 ↗
• MalfunctionOct 12, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN TRIED TO DEPLOY THE PIPELINE BUT THE DISTAL END WOULD NOT OPEN. AFTER THE PHYSICIAN TRIED MULTIPLE ATTEMPTS TO GET THE PIPELINE OPEN, THE PHYSICIAN COMPLETED THE SURGERY WITH ANOTHER PIPELINE. THE PIPELINE WAS POSITIONED IN A BEND AT THE PROXIMAL SECTION. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (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 (ICA) ANEURYSM WITH A MAX D IAMETER OF 6MM AND A 3MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 4.2MM DISTALLY AND 4.9MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE POST PROCEDURE ANGIOGRAPHIC RESULT WAS ADEQUATE.   ANCILLARY DEVICES INCLUDE A RIST SHEATH, PHENOM PLUS GUIDE CATHETER, ARISTOTLE 24 GUIDEWIRE, AND A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921166 ↗
• MalfunctionOct 5, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE "TRUMPETED" AT THE MIDDLE AND DISTAL ENDS AND WOULD NOT OPEN. THE PHYSICIAN ATTEMPTED 2 ADDITIONAL TIMES WITHOUT SUCCESS. AFTER THE THIRD ATTEMPT, THE PHYSICIAN ABORTED THE CASE AND ELECTED TO USE A DIFFERENT DEVICE. THE PIPELINE WAS NOT POSITIONED IN A BEND AND WAS LESS THAN 50% DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (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 INTERNAL CAROTID ARTERY (ICA) ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE POST PROCEDURE ANGIOGRAPHIC RESULT WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882976 ↗
• MalfunctionOct 2, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE DEVICES FAILED TO OPEN DISTALLY AND WOULD NOT RESOLVE AFTER MULTIPLE ATTEMPTS. BOTH WERE REMOVED AND A 4X18 WAS SUCCESSFULLY IMPLANTED. THE PIPELINES WERE POSITIONED IN A BEND IN THE MIDDLE. MORE THAN 50% OF THE PIPELINES WERE DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (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 LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DI AMETER OF 8MM AND A 5MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WAS 3.5MM DISTALLY AND 3.8MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED FULL WALL APPOSITION OF THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858252 ↗
• InjurySep 20, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS UNKNOWN IF SURGERY HAS BEEN RESCHEDULED. THERE WERE NO ADDITIONAL INTERVENTIONS TAKEN TO RESOLVE THE PARA-OPHTHALMIC ANEURYSM.

  Patient problems: Aneurysm

  MAUDE report 17785248 ↗
• MalfunctionAug 23, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE DISTAL END OF THE PIPELINE SHIELD DID NOT FULLY OPEN. THE PHYSICIAN TRIED USING THE PHENOM 27 MICROCATHETER TO BUMP OPEN THE PIPELINE, BUT WAS UNSUCCESSFUL. THE PHYSICIAN TRIED USING A J-WIRE SHAPED SYNCHRO STANDARD AND AN ASAHI 18 TO PLASTY THE DISTAL END, AGAIN WITHOUT SUCCESS. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE SECTION. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN DISTALLY AND WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (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 LEFT PARAOPTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A 4.2MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 4.3MM DISTALLY AND 8MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT RADIAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608341 ↗
• MalfunctionJun 1, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. IT WAS NOT POSITIONED IN A BEND. IT WAS NOT STUCK IN THE CAPTURE COIL. LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS REHEATED LESS THAN OR EQUAL TO TWO TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. THE PIPELINE WAS REHEATED 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 NA UNRUPTURED, SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA). THE DISTAL LANDING ZONE WAS 4.4MM AND THE PROXIMAL LANDING ZONE WAS 5.2MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PIPELINE DEVICE THAT WAS REMOVED CAME OFF IN THE MICROCATHETER WHICH WAS REMOVED AND REPLACED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042151 ↗
• MalfunctionMar 30, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE LANDING ZONE WAS 5MM AT THE DISTAL END AND 5MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE LEFT ICA WITH 5MM DIAMETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT A PHENOM 27 WAS ADVANCED INTO THE LEFT M1. ALL 3 PIPELINES WERE DEPLOYED BUT FAILED TO OPEN APPROXIMATELY 2MM PROXIMAL TO THE DISTAL END. THE MID-SECTION WOULD OPEN CORRECTLY BUT A CONSTRICTED AREA REMAINED APPROXIMATELY 2MM PROXIMAL TO THE DISTAL END. EACH DEVICE WAS REMOVED, THE FINAL DEVICE WAS DEPLOYED ONLY AFTER EXCHANGING THE PHENOM 27 FOR A NEW PHENOM 27 AT WHICH TIME DEPLOYMENT WAS AS EXPECTED AND THE CASE WAS COMPLETED. THE PIPELINES FAILED TO OPEN IN THE MIDDLE SECTION. THE PIPELINES WERE NOT POSITIONED IN A BEND. LESS THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THEY FAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643584 ↗
• MalfunctionJan 20, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE THAT FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 4.75 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT IS UNKNOWN IF DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS POSITIONED IN A DISTAL BEND. THE PIPELINE HAD BEEN DEPLOYED MORE THAT 50% WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE INCLUDING A WIRE/CATHETER. THE PIPELINE WAS REMOVED FROM THE PATIENT BY RESHEATHING AND REMOVING WITH THE MICROCATHETER. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215040 ↗
• MalfunctionJan 11, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE THAT FAILED TO OPEN IN THE DISTAL SEGMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 6 MM AND A 3.3 MM NECK DIAMETER. THE LANDING ZONE WAS 3.2 MM DISTALLY AND 4.8 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 10. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT THE DISTAL END OF THE PIPELINE DEVICE HAD THE TULIP SHAPE AND WOULD NOT OPEN. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL END. THE PIPELINE WAS POSITIONED IN A DISTAL BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT BY RESHEATHING AND REMOVED WITH THE MICROCATHETER. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF LABEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139040 ↗

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