PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00763000284619), received between Oct 27, 2021 and Jun 2, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (25 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM AT LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 4 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4 MM DISTALLY AND 4.75 MM PROXIMALLY. IT WAS UNKNOWN IF A DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE PED2 DISTAL END OF THE DEVICE CAME OUT ¿CIGARED¿ AND WOULD NOT OPEN FULLY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. 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 25361439 ↗
• MalfunctionDec 9, 2025Positioning Failure; Material Twisted/Bent; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Material Twisted/Bent; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT THE MIDDLE SECTION OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY (PED2) DEVICE WOULD NOT OPEN. IN BOTH PLANES IT LOOKED LIKE THE DEVICE WAS TWISTED. MULTIPLE RECAPTURE AND REDEPLOY ATTEMPTS WERE UNSUCCESSFUL IN OPENING THE STENT. MOVEMENT DURING PLACEMENT (DIFFICULT PLACEMENT/POSITIONING) WERE ALSO REPORTED. THE STENT AND MICROCATHETER WERE REMOVED AND A NEW PED2 FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.3 MM DISTALLY AND 4.9 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NOTED AS NEW DEVICE IMPLANTED AND ANEURYSM WAS TREATED SUCCESSFULLY WITH NEW DEVICE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). MULTIPLE PIPELINE DEVICES WERE NOT BEING USED WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758515 ↗
• MalfunctionMay 6, 2025Material Frayed; Activation Failure; Material Frayed; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE EMBOLIZATION DEVICES FAILED TO OPEN AT DISTAL SITE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM AT THE PARA OPHTHALMIC REGION WITH A MAX DIAMETER OF 4.7 MM AND AROUND 4- OR 5-MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE WAS 3.3MM DISTALLY AND 4.7 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT UPON UNSHEATHING OF THE DEVICE IN THE MIDDLE CEREBRAL ARTERY (MCA), THE DISTAL END OF THE PIPELINE EMBOLIZATION DEVICE (PED) FAILED TO OPEN AS INTENDED AND APPEARED FLUTED AT THE TIP AND FAILED TO OPEN PROPERLY. THIS WAS THE CASE FOR BOTH PIPELINE DEVICES THAT HAPPENED TWICE THE EXACT SAME WAY. THE DISTAL SECTION OF THE PIPELINES WERE POSITIONED IN A BEND. THE PIPELINES WERE DEPLOYED LESS THAN 50% WHEN THEY FAILED TO OPEN AND WERE RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINES. THE PIPELINES WERE RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THE PIPELINES WERE USED FOR AN INDICATION THAT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971581 ↗
• MalfunctionApr 28, 2025Structural Problem; Material Twisted/Bent; Activation Failure; Structural Problem; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 4 PIPELINES WOULD NOT OPEN DURING DEPLOYMENT. THERE WERE MULTIPLE TIMES THE DISTAL END WOULD NOT BE OPEN. THEN THE OPERATOR WAS ABLE TO GET THE DISTAL END OPEN BUT THE MIDDLE AND PROXIMAL SEGMENTS WERE RIBBONED AND NOT OPEN. EVENTUALLY THE PHYSICIAN ABORTED THE PROCEDURE AND NO DEVICE WAS IMPLANTED. THE PIPELINES WERE POSITIONED IN A BEND IN THE PROXIMAL, MIDDLE AND DISTAL SECTIONS. MORE THAN 50% OF THE 4 PIPELINES HAD BEEN DEPLOYED WHEN THEY FAILED TO OPEN. THE PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINES. THE DEVICES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINES WERE USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES 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 CAVERNOUS ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.7MM AND PROXIMAL: 4.5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920881 ↗
• MalfunctionApr 2, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO ISSUE WITH THE PHENOM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751837 ↗
• MalfunctionFeb 25, 2025Activation, Positioning or Separation Problem; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER FURTHER DISCUSSING THE CASE WITH THE PERFORMING PHYSICIAN, THEY FELT THE CAUSE OF THE FAILURE TO OPEN/DAMAGE/RESISTANCE WAS THAT IT WAS DUE TO THE CATHETER BINDING UP SECONDARY TO A VERY TORTUOUS INTERNAL CAROTID ARTERY AND DID NOT FEEL IT WAS A ¿DEVICE FAILURE.¿ CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464622 ↗
• MalfunctionFeb 5, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PREMATURE DEPLOYMENT OCCURED WHEN ATTEMPTING TO RESHEATH THE DEVICE. THE PUSHWIRE ROTATED OR PULLED BACK IN ORDER TO RESHEATH. THREE DEVCIES WERE RETURNED. ONE REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318448 ↗
• MalfunctionJan 17, 2025Retraction Problem; Device Damaged Prior to Use; Packaging Problem; Physical Resistance/Sticking; Retraction Problem; Device Damaged Prior to Use; Packaging Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A NEARBY PED MODEL PRODUCT WAS SUBSEQUENTLY REPLACED AND THE SURGERY WAS COMPLETED. THE CAUSE OF THE SHEATH BEING IN A CLOSED STATE WAS THE PROFESSOR CONFIRMED THAT WHEN IT WAS OPENED, IT WAS IMMEDIATELY DISCOVERED THAT SHEATH WAS IN A CLOSED STATE, AND THEN IT WAS OPENED WITH SURGICAL SCISSORS. THE CAUSE OF THE RESISTANCE WAS UNKNOWN, THE PROFESSOR REPEATEDLY STRESSED THAT THE STENT COULD NOT BE RETRIEVED AND THEREFORE COULD NOT BE REPOSITIONED FOR DEPLOYMENT. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178518 ↗
• MalfunctionOct 7, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE WAS COMPLETED BY IMPLANTING A PIPELINE VANTAGE SUCCESSFULLY. THE CAUSE OF THE PIPELINE FAILURE WAS DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388882 ↗
• MalfunctionJul 16, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) FELT IT WAS USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752539 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 3.5 MM AND A 2.9 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.25 MM AND PROXIMAL: 4.72 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 70. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A NORMAL ANGIO, WITH PIPELINE EMBOLIZATION OF ICA ANEURYSM. IT WAS REPORTED THAT NORMAL PIPELINE DEPLOYMENT OF A 4.75 X 16 MM DEVICE. DISTAL END WAS SLIGHTLY LAZY, BUT OPEN. UPON PULLING THE PUSHER WIRE OUT OF THE CATHETER, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE PUSHER WIRE (SLEEVES AND LEAD WIRE) WERE BROKEN OFF AND STUCK IN THE RHV. IT WAS REPORTED PUSHWIRE BREAK OCCURRED WITH THE TIP COIL DETACHED. THE BROKEN SEGMENT OF THE PUSHWIRE WAS REMOVED FROM THE PATIENT. THERE WAS NO FRICTION OR DIFFICULTY. THE PIPELINE WAS IMPLANTED IN THE PATIENT. IT WAS REPORTED THIS WAS A NORMAL DEPLOYMENT, WITH NO RESHEATHING, ISSUE DID NOT OCCUR UNTIL THE PUSHER WIRE WAS BEING REMOVED. PATIENT IS DOING WELL. THE PIPELINE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896305 ↗
• MalfunctionMar 11, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE REASON WHY THE TIP END OF THE PIPELINE COULD NOT BE OPENED MIGHT BE THAT THE SMALL WINGS AT THE TIP END WERE BOUND OR STUCK. IN THIS OPERATION, THE PIPELINE WAS PLACED ON THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY TO OPEN, NOT ON THE CURVED PORTION OF THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877959 ↗
• MalfunctionJan 3, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. MULTIPLE ATTEMPTS WERE MADE TO GET THE DEVICE TO OPEN PROPERLY. THE DEVICE WAS NOT DEPLOYED DUE TO IT NOT OPENING. THE PIPELINE WAS PLACED IN A DISTAL BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. 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 RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE WAS 3.3MM DISTALLY AND 4.7MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANGIOGRAPHIC RESULT POST PROCEDURE REVEALED SUCCESSFUL PLACEMENT OF ANOTHER PIPELINE DEVICE. ANCILLARY DEVICES INCLUDE A RIST 079 REF 107F-079-95 ; LOT 20101-01 SHEATH, PHENOM PLUS FG19120-1030-1S ; LOT 225638850 GUIDE CATHETER, PHENOM 27 F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440383 ↗
• MalfunctionDec 19, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361170 ↗
• InjuryDec 14, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINE DEVICES FAILED TO OPEN IN THE DISTAL SECTION. THE PROCEDURE WAS ULTIMATELY ABORTED DUE TO DIFFICULTY PLACING THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 4.5 MM DISTALLY AND 4.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESSED VESSEL WAS THE ICA. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NOT COMPLETED BECAUSE THE PROCEDURE WAS ABORTED DUE TO DIFFICULTIES PLACING THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO GET THE 500 X 18 PIPELINE SHIELD (PED2-500-18) TO OPEN ON THE DISTAL END. HE TRIED MULTIPLE TIMES TO OPEN THE DEVICE BUT THE DISTAL END WOULD NOT OPEN. THE MEDIAL SEGMENT DID OPEN. PHYSICIAN BECAME CONCERNED THAT THERE WAS SOMETHING WRONG WITH THE 5X18 PIPELINE SHIELD DEVICE AND ELECTED TO REMOVE THE SYSTEM AND TRY A DIFFERENT DEVICE. HE THEN LOADED A 5.00 X 16 PIPELINE SHIELD (PED2-500-16) INTO A NEW PHENOM 27 MICRO-CATHETER AND TRIED TO DELIVER THE PIPELINE BUT EXPERIE

  Patient problems: Failure of Implant

  MAUDE report 18326162 ↗
• MalfunctionOct 12, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT OPEN IN THE MIDDLE SECTION. MANY ATTEMPTS WERE MADE TO GET THE PIPELINE TO OPEN, BUT I NEVER DID. IT WAS NEVER DEPLOYED AND REMOVED FROM THE BODY. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE SECTION. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. 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 ANEURYSM WITH A MAX DIAMETER OF 4.69MM AND A 9.10MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 4MM DISTALLY AND 4.69MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED WITH A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 202.   ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER AND A SYNCHRO 14 GUIDEIWRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920481 ↗
• MalfunctionSep 25, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. WHILE DEPLOYING THE PIPELINE, THE DISTAL END WAS NOT OPENING PROPERLY. WE RECAPTURED 2 TIMES AND DECIDED TO TRY A NEW DEVICE. WHEN THE DEVICE WAS REMOVED THE DISTAL END WAS NOTICEABLY FRAYED. SECOND DEVICE DEPLOYED WITH NO ISSUES. THE DISTAL SECTION OF THE PIPELINE WAS PLACED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLYED WHEN IT FAILED TO OPEN. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE CAVERNOUS LOCATION. THE MAX DIAMETER WAS 9MM AND THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 3.83MM AND THE PROXIMAL LANDING ZONE WAS 4.8MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. NO PATIENT SYMPTOSM OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814869 ↗
• 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 17785232 ↗
• InjuryMay 11, 2023Activation, 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 THAT THERE WAS NOT ADDITIONAL OR PLANNED MEDICINAL OR SURGICAL INTERVENTIONS REQUIRED AS A RESULT OF THE PIPELINE STENOSIS. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION COVERING THE PARACLINOID ANEURYSM AND THE DEVICE WENT A LITTLE LONG. THE DISTAL LANDING WAS JUST PROXIMAL TO THE POSTERIOR COMMUNICATING ARTERY. PROXIMALLY IT LANDED IN THE VERTICAL SEGMENT OF THE CAVERNOUS INTERNAL CAROTID ARTERY.

  Patient problems: Stenosis

  MAUDE report 16911120 ↗
• MalfunctionApr 3, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16666221 ↗
• MalfunctionDec 13, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN SAID THAT THE DEVICE LOOKED FRAYED AND DIDN¿T APPEAR TO BE OPEN FULLY DISTALLY, HE THEN REMOVED THE DEVICE IN THE MICRO CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE WAS 4MM AT THE DISTAL END AND 4.2MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICE FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. WHEN A NEW DEVICE WAS PUT IN, THE RESULT WAS ACCEPTABLE. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968642 ↗
• MalfunctionOct 27, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ADVANCED A PIPELINE INTO THE DISTAL ICA AND BEGAN TO DEPLOY THE DEVICE WITH THE DISTAL END POSITIONED IN THE PARAOPHTALMIC REGION. THE DEVICE BEGAN TO OPEN BUT THEN SHOWED A NARROWING/TRUMPETING IN THE DISTAL END. THE DEVICE BEGAN TO OPEN PROXIMAL TO THAT DISTAL NARROWING BUT THE PHYSICIAN WOULD NOT FINISH THE DEPLOYMENT DUE TO THE DISTAL END NOT BEING OPENED. THE DEVICE WAS REMOVED AND ANOTHER PIPELINE WAS ADVANCED THROUGH THE CATHETER ALL THE WAY TO THE M1 REGION OF THE PATIENT. THE M1 REGION WAS MUCH STRAIGHTER AND THE PHYSICIAN BEGAN DEPLOYING THE DEVICE. THIS TIME THE DISTAL END OPENED WITHOUT NARROWING/TRUMPETING. THE PHYSICIAN LET OUT ABOUT 8MM (1/2) OF THE DEVICE AND THEN RESHEATHED THE DEVICE COMPLETELY. SHE THEN PULLED THE SYSTEM PROXIMAL INTO THE SAME SEGMENT WHERE SHE TRIED TO DEPLOY THE FIRST DEVICE (PARAOPTHALMIC). SHE BEGAN TO DEPLOY THE DEVICE AGAIN AND THE SAME PHENOMENON HAPPENED WITH THE DISTAL NARROWING/TRUMPETING. THE PHYSICIAN REMOVED THE DEVICE AND ENDED THE CASE. THE FIRST PIPELINE WAS NOT POSITIONED IN A BEND. THE SECOND PIPELINE PROXIMAL SECTION WAS POSITIONED IN A BEND. MORE THAN 50% OF THE BOTH PIPELINES HAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681567 ↗
• MalfunctionOct 11, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 4 PIPELINES FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER WAS 3.2MM, AND THE NECK DIAMETER WAS 2.7MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.0MM DISTAL AND 4.69MM PROXIMAL. IT WAS REPORTED THAT THE 4 PIPELINES FAILED TO OPEN IN THE DISTAL ICA. ALL 4 DEVICES LOOKED CRIMPED IN THE DISTAL SEGMENT. FINALLY, THE PHYSICIAN WAS ABLE TO OPEN A FIFTH PIPELINE IN THE M1 SEGMENT AND DRAG THE PIPELINE TO THE LANDING LOCATION FOR SUCCESSFUL DEPLOYMENT. THE PIPELINES HAD BEEN IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN THEY FAILED TO OPEN. THE PIPELINES HAD EACH BEEN RESHEATHED MORE THAN 2 TIMES, AND NO OTHER STEPS WERE TAKEN TO OPEN THEM. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED SUCCESSFUL DEPLOYMENT OF THE DEVICE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER AND A NAVIEN 058 GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584553 ↗
• MalfunctionFeb 8, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 PIPELINE FLEX WITH SHIELD STENTS THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED 6MM SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS. THE DISTAL LANDING ZONE WAS 2.06MM AND THE PROXIMAL LANDING ZONE WAS 4.75MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THE PIPELINES ARE ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE FIRST PIPELINE (MODEL: PED2-475-14, LOT: B284830) WAS TAKEN UP TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) TO DEPLOY AND DRAG BACK. UPON DEPLOYMENT, THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THE PHYSICIAN ATTEMPTED 3 TIMES TO RESHEATH AND DEPLOY THE DEVICE WITHOUT SUCCESSFUL OPENING OF THE PIPELINE. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT POSITIONED IN A BEND. THERE WERE NO OTHER STEPS OR DEVICES TRIED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. A SECOND PIPELINE (MODEL: PED2-475-16, LOT: B271888) WAS THEN USED AND TAKEN TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13485953 ↗
• MalfunctionNov 12, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES FAILED TO OPEN DISTALLY AND THERE WAS RESISTANCE IN THE PROXIMAL PART OF THREE PHENOM 27 MICROCATHETERS. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE RIGHT ICA. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.7MM DISTAL AND 4.7MM PROXIMAL. THE ACCESS VESSEL WAS THE RIGHT ICA, WHICH WAS 5MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 114. IT WAS REPORTED THAT THE FIRST PIPELINE WAS ADVANCED INTO THE MIDDLE CEREBRAL ARTERY. THE DISTAL OPENED AND THE DOCTOR PULLED IT BACK TO ITS DISTAL LANDING ZONE. THE MOST DISTAL PART OPENED WELL, BUT 2-3MM PROXIMAL TO THE DISTAL END THE DEVICE APPEARED CONSTRAINED. THE MAJORITY OF THE DEVICE WAS DEPLOYED AND ALL THE MIDSECTION COMPLETELY OPENED WITH THAT SMALL CONSTRAINED AREA UNCHANGED. THE DEVICE WAS RECAPTURED. IT WAS NOTICED THAT THE PRESSURE TO RESHEATH WAS DAMAGING TO THE PHENOM 27 CATHETER, AND IT WAS ACCORDIONING AT ITS PROXIMAL SECTION. BOTH THE PHENOM 27 AND PIPELINE WERE REMOVED FROM THE BODY AND REPLACED. THE EXACT SAME PROBLEM OCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807328 ↗

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-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-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-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