PIPELINE PED-475-14Recalls & reported problems
Micro Therapeutics, Inc. · PED-475-14 PIPELINE FLEX 4.75MM X 14MM · Class 3 · Implant
All models of PIPELINE (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00847536016651), received between Mar 25, 2016 and Sep 20, 2021 — classified as 3 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (14 reports).
1 FDA recall record name this device's identifier, 1 still open.
11 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.
Recalls naming this device
- Jul 13, 2021Class IOpen, Classified
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Activation Failure14
- Physical Resistance/Sticking2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient5
- Fistula1
- Foreign Body In Patient1
- Thrombosis/Thrombus1
- Vasoconstriction1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WAS NOT OPENING. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN OPHTHALMIC, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 1.5MM AND A 3MM NECK DIAMETER. THE MORPHOLOGY INCLUDED A BLISTER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PHYSICIAN WENT TO DEPLOY THE PIPELINE 4.75 X 14 AND WAS NOTIFIED THE DISTAL END WAS NOT OPENING. IT WAS INDICATED THE MIDDLE AND PROXIMAL PARTS OF THE PIPELINE WERE POSITIONED IN A BEND. THE PHYSICIAN RECAPTURED THE DEVICE AND OPENED AGAIN, HOWEVER, THE DISTAL END WOULD NOT OPEN. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RE-SHEATHED MORE THAN TWO TIMES WITH THE MICROCATHETER. THE PRODUCT WAS REMOVED BY THE PHYSICIAN AND A PIPELINE 4.75 X 12 WAS INSERTED. THE 4.75 X 12 OPENED DISTORT, HOWEVER, DURING THE DEPLOYMENT THERE WAS RIBBON IN THE MID-SECTION AND THE DEVICE WOULD NOT OPEN. A RECAPTURING OF THE DEVICE OCCURRED AND THE DEPLOYMENT WAS ATTEMPTED THREE TIMES BUT THERE WAS A RIBBON IN THE SAME SECTION. ONCE AGAIN, MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12495086 ↗MalfunctionSep 8, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT PHYSICIAN DEPLOYED PIPELINE FLEX 4.75X14 IN THE DISTAL INTERNAL CAROTID ARTERY. THE DEVICE BEGAN TO OPEN BUT THEN IT LOOKED FISHMOUTHED IN THE DISTAL END. THE DEVICE WAS RESHEATHED AND THEN REMOVED WITH THE MICROCATHETER. THE PIPELINE WAS PLACED IN A BEND IN THE DISTAL SECTION. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THERE WAS SUCCESSFUL DEPLOYMENT OF A NEW DEVICE, PED-475-14.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443785 ↗MalfunctionJul 22, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE FAILED TO OPEN AT THE DISTAL END WHEN DEPLOYED. IT WAS RESHEATHED MORE THAN 2 TIMES BUT STILL FAILED TO OPEN. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPENED WAS OBSERVED. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND. NO ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. BOTH THE PIPELINE AND THE MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. POST-PROCEDURE ANGIOGRAPHY SHOWED GOOD WALL APPOSITION. POTENTIAL PLATELET AGGREGATION WAS NOTED. INTEGRILIN WAS ADMINISTERED AND PATIENT WAS REPORTED TO BE WITHOUT INJURY. ANCILLARY DEVICE: PHENOM 27 MICROCATHETER.
Patient problems: Thrombosis/Thrombus
MAUDE report 12211604 ↗MalfunctionJul 13, 2021Activation Failure; Activation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE DEVICE STARTED TO OPEN ON THE FIRST DEPLOYMENT ATTEMPT. THE DEVICE FAILURE TO OPEN WAS WORSE ON SUBSEQUENT DEPLOYMENT ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12160055 ↗MalfunctionJul 9, 2021Activation Failure; Activation Failure
ADDITIONAL INFORMATION WAS RECEIVED ON 2021-JUL-13. IT WAS REPORTED THAT THE DOCTOR DOES NOT RECALL THE TIP OF THE CATHETER BEING UNDER STRESS WHEN THE CATHETER JUMPED. NO ADDITIONAL PIPELINE OR OTHER TREATMENT HAS BEEN ADMINISTERED TO ADDRESS THE INCOMPLETE NECK COVERAGE, AND NONE IS PLANNED AT THIS TIME. NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT,ANGIO, ETC.) ARE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12143675 ↗MalfunctionJun 2, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE NEURONMAX WAS DELIVERED TO THE DISTAL CAROTID AND EXPLOITED HIGH PRESSURES ON THE INTERMEDIATE CATHETER ON THE POSTERIOR GENUE. UPON DELIVERY OF THE PIPELINE, IT WAS NOTICED THERE WAS NARROWING OF THE DEVICE WITH THREE ATTEMPTS TO DEPLOY WITH UNFORTUNATE RESOLUTION. THE DISTAL SEGMENT OF THE PIPELINE HAD FAILED TO OPEN. THE ENTIRE SYSTEM WAS THEN REMOVED. A REPLACEMENT DEVICE OF A LONGER MODEL WAS USED WITH A NEW DELIVERY SYSTEM TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THE DEPLOYED DEVICE WAS WELL APPOSED WITH CLEAR DISTAL AND PROXIMAL WALL APPOSITION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FISTULA OF THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 3 MM AND A 3 MM NECK DIAMETER. THE PHYSICIAN ACKNOWLEDGED THIS WAS AN OFF-;LABEL USE OF THE DEVICE BUT FELT THE PIPELINE WAS BEST FIT TO TREAT THE PATIENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE, AND THE PHYSICIAN STATED THE ANATOMY POSED DIFFICULTY. I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11921517 ↗InjuryMay 5, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE TWO PIPELINE DEVICES FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE PARAOPHTHALMIC SECTION OF THE RIGHT ICA. THE MAX DIAMETER WAS 4.18MM, AND THE NECK DIAMETER WAS 4.28MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE WAS 4.18MM DISTAL AND 4.87MM PROXIMAL.¿DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 60. IT WAS REPORTED THAT THE DOCTOR¿ATTEMPTED TO DEPLOY THE PED-500-12 AS PER THE INSTRUCTIONS FOR USE (IFU), BUT IT DID NOT OPEN. THE DISTAL PORTION SLIGHTLY OPENED BUT WAS SEVERELY FLAT AROUND THE GENU. THE PHYSICIAN ATTEMPTED TO RESHEATH AND CENTER THE DEVICE, AND HAD THE NAVIEN CATHETER IN THE VERTICAL PETROUS SEGMENT. AFTER SEVERAL ATTEMPTS, THE DOCTOR PULLED OUT THE DEVICE ALONG WITH THE¿ MARKSMAN CATHETER. THE DOCTOR REPLACED THE MARKSMAN AND DOWNSIZED THE PIPELINE TO A PED-475-14. THEY ATTEMPTED TO OPEN IN THE MIDDLE CEREBRAL ARTERY SEGMENT (MCA), BUT THE PIPELINE DID NOT OPEN DISTALLY OR "CIGARED" WHERE THE MIDDLE PORTION WOULD OPEN. THE PHYSICIAN PUSHED THE WIRE MORE THAN 50% WITH BOTH DEVICES WHEN THEY FAILED TO OPEN. AFTER NOTICING SPASM IN T
Patient problems: Vasoconstriction
MAUDE report 11780552 ↗MalfunctionDec 11, 2020Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10993231 ↗MalfunctionNov 23, 2020Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE DEVICE DID NOT DEPLOY AFTER RESHEATHING ONE TIME. THERE WAS NO PATIENT HARM AND THE PROCEDURE COMPLETED WITH A REPLACEMENT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10889287 ↗MalfunctionDec 23, 2019Activation Failure; Activation Failure
MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLEX DEVICE FAILED TO OPEN. THE LEFT ICA WAS TORTUOUS LEADING UP TO THE ANEURYSM- THE ANEURYSM BEING LOCATED JUST DISTAL TO THE ANTERIOR GENU AND THE ORIGIN OF THE OPHTHALMIC ARTERY. THERE WAS DIFFICULTY GETTING ANY WIRE TO PASS THE PCOM BRANCH TO GET TO THE MCA TO ALLOW THE PHENOM 27 TO TRACK. AFTER SUCCESSFULLY GETTING THE WIRE (TRANSCEND) TO THE M1, THE CASE PROCEEDED. A TOTAL OF 3 PIPELINE DEVICES WERE USED- ONLY THE FINAL DEVICE WAS DEPLOYED. THE FIRST DEVICE OPENED WAS A 4.75X16 CONSIGNED PRODUCT LOT A835655, WHICH DID NOT OPEN WHEN PLACED IN THE M1. ONLY VERY DISTAL OPENING WAS OBSERVED, AND THE DEVICE WAS PULLED BACK TO A LARGER DIAMETER VESSEL AND MORE OF THE DEVICE RELEASED TO SEE IF IT WOULD OPEN. THE PTFE SLEEVES WERE "BUMPED" BACK WITHOUT SUCCESSFUL DEVICE OPENING. MORE SUPPORT WAS GARNERED FROM THE NAVIEN AND PHENOM- LOADING THE ENTIRE SYSTEM WITHOUT SUCCESSFUL OPENING OF THE DEVICE. THIS DEVICE WAS THEN REMOVED AND A 4.75X14 (TRUNK STOCK) DEVICE WAS OPENED LOT A873205. THIS DEVICE BEHAVED IN A SIMILAR FASHION- WITH A RIBBON SHAPED APPEARANCE ANGIOGRAPHICALLY. AFTER MUCH MANIPULATION OF THE DEVICE IT BECAME CLEAR THAT IT WOULD
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9511165 ↗InjuryDec 21, 2019Break; Activation Failure; Break; Activation Failure
MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX WIRE FRACTURE. DURING THE PROCEDURE, THE PIPELINE FLEX DEVICE WAS PARTIALLY DEPLOYED INTO THE RIGHT MCA AND THEN RETRACTED INTO PREDETERMINE DISTAL ZONE, JUST PROXIMAL TO THE ANTERIOR CHOROIDAL ARTERY. THE PIPELINE WAS THEN DEPLOYED INTO THE ANTERIOR GENU WITHOUT COMPLICATION. THERE WAS MODERATE MANIPULATION DONE TO THE PROXIMAL PORTION OF THE DEVICE IN THE DISTAL LANDING ZONE TO GET IT TO OPEN FULLY. DEVICE WAS THEN FULLY DEPLOYED AND THE CATHETER WAS TRACKED BACK OVER THE DEVICE WIRE FOR RECAPTURE. THE PROXIMAL PORTION OF THE DEVICE CAUGHT AND PUSHED 2MM DISTAL, BUT THE DEVICE LOOKED GOOD AND WELL OPPOSED OTHERWISE. AT SOME POINT THE DISTAL PORTION OF THE PIPELINE WIRE BROKE OFF INTO THE CATHETER AND WAS THEN PUSHED OUT INTO THE ARTERY. THE TREATING PHYSICIAN THEN SNARED THE DISTAL PORTION, BUT THE WIRE SLIPPED OFF WHILE RETRIEVING AND STENTS WERE THEN USED TO PIN THE WIRE TO THE VESSEL WALL. THE BROKEN DISTAL SECTION WAS LEFT IN THE RIGHT ICA, PROXIMAL TO THE PIPELINE. THE PATIENT REMAINED ASYMPTOMATIC. THE POST PROCEDURE ANGIOGRAPHIC WAS CLEAN A NO DEFICITS NOTED. THE TREATING LOCATION WAS THE RIGHT ICA, OPHTHALMIC REGION. THE ANEURY
Patient problems: Foreign Body In Patient
MAUDE report 9508527 ↗MalfunctionNov 22, 2019Activation Failure; Activation Failure
MEDTRONIC RECEIVED INFORMATION THAT PIPELINE WOULD NOT OPEN DURING DEPLOYMENT. IT WAS REPORTED THAT PIPELINE FLEX DEVICE DID NOT OPEN AT THE MIDDLE AND DISTAL END. THEY DEPLOYED ANOTHER DEVICE AND IT WENT WELL. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PIPELINE WAS NOT POSITIONED IN A BEND. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY WAS REPORTED. THERE WAS NO FURTHER INFORMATION AVAILABLE FROM THE CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9362201 ↗MalfunctionNov 17, 2019Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL END. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW DEVICES WITH GOOD RESULTS. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR AN UNRUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9333617 ↗InjuryNov 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT OF CAROTID CAVERNOUS FISTULA DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA.) ANATOMY WAS REPORTEDLY VERY TORTUOUS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT DURING THE PROCEDURE, A PIPELINE FLEX WAS ATTEMPTED TO BE PLACED. DURING ADVANCEMENT OF THE PIPELINE FLEX, A LARGE AMOUNT OF FORCE WAS REQUIRED THROUGH THE DISTAL SECTION OF THE PHENOM CATHETER. THE PROCEDURE WAS ABANDONED AND A CAROTID CAVERNOUS FISTULA (CCF) WAS NOTED. THE CCF WAS COILED. THE PATIENT DID NOT EXPERIENCE A NEUROLOGICAL DECLINE FROM BASELINE.
Patient problems: Fistula
MAUDE report 9268971 ↗MalfunctionMay 1, 2018Activation Failure; Activation Failure
MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FAILED TO OPEN AND WAS DAMAGED AT THE DISTAL SECTION. THE PIPELINE AND THE CATHETER WERE REMOVED AS A SYSTEM. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, LEFT PCOM ANEURYSM, THAT WAS SACCULAR. THE MAX DIAMETER WAS 11 MM WITH A NECK WIDTH OF 4.5MM. THE DISTAL LANDING ZONE WAS 4.82MM AND THE PROXIMAL WAS 4.32MM. THE ANATOMY WAS MODERATE IN TORTUOSITY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE ALL USED PER THE IFU. THE PIPELINE WAS REPORTED TO HAVE BEEN PLACED ON A BEND AND THE DEVICE FAILED TO OPEN AT THE DISTAL SECTION OF THE TREATING VESSEL. LESS THAN 50% WAS DEPLOYED WHEN THE DEVICE FAILED TO OPEN. THE PIPELINE RESHEATHED LESS THAN OR EQUAL TO 2 TIMES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7476626 ↗MalfunctionMar 25, 2016Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking
MEDTRONIC RECEIVED REPORT OF PIPELINE FLEX PUSH WIRE BREAK DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE LEFT OPHTHALMIC INTERNAL CAROTID ARTERY (ICA). MAX DIAMETER WAS 6MM AND NECK DIAMETER WAS 4MM. LANDING ZONE ARTERY SIZE WAS 3.8MM DISTAL AND 4.4 MM PROXIMAL. THE VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AND USED AS PER IFU. THE PIPELINE FLEX WAS DELIVERED TO THE DISTAL END OF THE CATHETER WITH A NORMAL AMOUNT OF RESISTANCE. THE PIPELINE FLEX WAS PARTIALLY UNSHEATHED AND THE PHYSICIAN DECIDED TO REPOSITION IT. THE PHYSICIAN ATTEMPTED TO RESHEATH, BUT THE PUSH WIRE (WHICH WAS STILL WITHIN THE CATHETER) BROKE IN THE DISTAL SECTION. THIS OCCURRED DURING THE FIRST RE-SHEATHING ATTEMPT. THE SYSTEM (PIPELINE FLEX AND CATHETER) WAS REMOVED FROM THE PATIENT TOGETHER. THE PIPELINE FLEX WILL BE RETURNED FOR EVALUATION. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT. SEE PE 701216519 FOR THE POST-PROCEDURE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5527693 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.
- Z-1246-2025 · Jan 30, 2025 · Open, ClassifiedMedtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
- Z-1245-2025 · Jan 30, 2025 · Open, ClassifiedMedtronic 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-2403-2021 · Jul 13, 2021 · Open, ClassifiedEV3 Pipeline Flex Embolization Device with Flex Shield Technology
- Z-1527-2020 · Feb 14, 2020 · Terminatedev3 Pipeline Flex Embolization Device. For neurological endovascular use.
- Z-0309-2017 · Oct 5, 2016 · TerminatedMarathon 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-0307-2017 · Oct 5, 2016 · TerminatedPipeline 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-0308-2017 · Oct 5, 2016 · TerminatedAlligator 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-0310-2017 · Oct 5, 2016 · TerminatedX-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-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 · TerminatedPipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
- Z-2045-2013 · Jul 19, 2013 · TerminatedPipeline 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
Other Intracranial aneurysm flow diverter devices
- Pipeline TM Flex Embolization Device with Shield Technology TM PED2-300-12Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter2 recalls1 report
- PIPELINE PED-500-20Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall31 reports
- PIPELINE PED-500-35Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death29 reports
- PIPELINE PED-500-16Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall2 deaths27 reports
- PIPELINE PED-500-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death23 reports
- PIPELINE PED-500-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall21 reports
- PIPELINE PED-450-25Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall20 reports
- PIPELINE PED-475-30Micro Therapeutics, Inc. · Intracranial aneurysm flow diverter1 recall1 death19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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