PIPELINE PED-500-18Recalls & reported problems
Micro Therapeutics, Inc. · PED-500-18 PIPELINE FLEX 5.00MM X 18MM · Class 3 · Implant
All models of PIPELINE (114)
Data updated Oct 16, 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
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536019690), received between Apr 10, 2017 and Jun 9, 2022 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (13 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 16, 2026.
Recalls naming this device
- Jul 13, 2021Open, 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 Failure13
- Break1
- Material Deformation1
- Physical Resistance/Sticking1
- Unintended Ejection1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient4
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2022Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE PROXIMAL AND MIDDLE SECTION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER AND NECK DIAMETER WERE 2.6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.3MM DISTAL AND 4.2MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 151. IT WAS REPORTED THAT THE PHYSICIAN CHANGED TECHNIQUE MANY TIMES TO ATTEMPT TO OPEN THE DEVICE WITHOUT SUCCESS. THE PROXIMAL AND MIDDLE PARTS OF THE DEVICE WERE PLACED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THE REPLACEMENT DEVICE DEPLOYED SUCCESSFULLY WITH NO IMMEDIATE COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A RIST 7FR SHEATH, PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND SYNCHRO STANDARD SELECT GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14645847 ↗MalfunctionNov 19, 2021Activation Failure; Activation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE WAS PLACED IN THE STRAIGHT PART OF THE BLOOD VESSEL. ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE WAS INDICATED AS HAD TRIED TO RECYCLE AGAIN, PUSHED LONG ENOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12844692 ↗MalfunctionSep 24, 2021Activation 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 LEFT OPHTHALMIC ARTERY SEGMENT. THE LANDING ZONE WAS 4.7MM ON THE DISTAL SIDE AND 4.5MM ON THE PROXIMAL SIDE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PED WAS HALF DEPLOYED, AND IT WAS FLATTENED. AFTER SEVERAL SWINGS, IT COULD NOT BE OPENED. TOOK IT OUT OF THE BODY AND PUSHED IT OUT FROM THE MICROCATHETER. THE PROXIMAL END STILL COULD NOT BE OPENED. THE PROXIMAL PART OF THE PIPELINE WAS POSITIONED IN A BEND. LESS 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 OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT BY CUTTING THE MICROCATHETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, THE PRU LEVEL WAS UNKNOWN. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SLOWED BLOOD FLOW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED, AND THEY WERE PREPARED AS INDICATED IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12527157 ↗MalfunctionJul 20, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER AND WIRE WERE PLACED SMOOTHLY. THE PIPELINE WAS PUSHED OUT OF THE MIDDLE CEREBRAL ARTERY (MCA), BUT THE DISTAL END DID NOT OPEN WELL. AFTER DEPLOYING ENOUGH LENGTH, THE MIDDLE SECTION OPENED, BUT THE TIP WAS STILL NOT FULLY OPENED. PULLING THE DEVICE BACK TO THE C7 BIFURCATION, THE DISTAL END WAS STILL NOT OPENED, AND THE UPPER-HIGH NAVIEN REPEATEDLY INCREASED AND DECREASED AND SWUNG, BUT THE EFFECT WAS NOT IDEAL. THE DEVICE WAS RESHEATHED AND THE STEPS WERE REPERFORMED UP TO THE M1. THE DISTAL END STILL DID NOT OPEN. FLUOROSCOPY SHOWED THE DISTAL END OF THE PIPELINE HAD OBVIOUS ROUGHNESS AND THE FORMATION OF A SPOUT. THE PIPELINE AND MARKSMAN WERE WITHDRAWN FROM THE BODY. REPLACEMENT DEVICES WERE USED TO 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 CONTRAST RETENTION IN THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12196669 ↗MalfunctionMay 26, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT ANATOMY WAS VERY TORTUOUS, AND THE PIPELINE WOULD NOT OPEN PROPERLY RIGHT BEFORE THE DISTAL END. THE STENT OPENED A LITTLE, AND THEN NARROWED/FLATTENED. THE DEVICE WAS NOT POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. MULTIPLE MANEUVERS WERE ATTEMPTED: WAGGING, RE-SHEATHING MORE THAN TWICE, AND REPOSITIONING AND REDEPLOYMENT. FINALLY, THE PHYSICIAN REMOVED THE DEVICE WITH THE MICROCATHETER, AND REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH NO REPORTED ISSUES. 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 WERE NORMAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM OF THE LEFT CAVERNOUS INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 18 MM AND A 7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS NOT REPORTED. ANCILLARY DEVICES INCLUDE A 6F STRYKER INFINITY LO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11884896 ↗MalfunctionMay 17, 2021Unintended Ejection; Physical Resistance/Sticking; Unintended Ejection; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SUSPECTED CAUSE OF THE EVENT WAS THAT THE BLOOD VESSEL WAS TOO TORTUOUS AND THE DIAMETER OF THE MARKSMAN WAS AFFECTED. THE SURGEON REPORTED THAT THE PUSH ROD HAD A LARGE RESISTANCE. IT WAS SUSPECTED THAT THE INTERNAL LUMEN WAS UNSTABLE DUE TO THE EXCESSIVE BENDING OF THE MICROCATHETER, WHICH HAD THE PIPELINE UNLOADED IN THE MICROCATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11836327 ↗MalfunctionApr 15, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT DISTAL END OF THE PIPELINE COULD NOT BE OPENED. REPEATED ATTEMPTS WERE TRIED BUT THE ISSUE PERSISTED, SO THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. UPON REMOVAL IT WAS FOUND THAT THE TIP OF THE PIPELINE WAS BURR-LIKE. THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR RIGHT CAVERNOUS SINUS ANEURYSM WITH A DIAMETER OF 15X13MM AND A NECK WIDTH OF 4MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THE DEVICE WAS NOT PLACED IN A BEND AND LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. MORE THAN 2 RESHEATHING ATTEMPTS WERE MADE AND NO ADDITION A STEPS WERE TAKEN TO OPEN THE DEVICE. ANCILLARY DEVICES INCLUDE A 6F NAVIEN GUIDE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11676202 ↗MalfunctionMar 11, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND WHEN THE FAILURE TO OPEN OCCURRED, THE VESSEL WAS STRAIGHT. THE PHYSICIAN WIGGLED THE WIRE AND ADJUSTED THE SLACK IN THE SYSTEM BUT STILL COULD NOT OPEN THE PIPELINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11462028 ↗MalfunctionMar 10, 2021Activation Failure; Activation Failure
MEDTRONIC RECEIVED A REPORT THAT THE TIP END OF THE PIPELINE COULD NOT BE OPENED. AFTER MANY ATTEMPTS, THE PROXIMAL END OPENED WELL, BUT THE TIP END STILL COULD NOT BE OPENED. A NEW PIPELINE AND PHENOM CATHETER WERE THEN USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED/FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU), AND 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 OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTH ALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 3.2 MM AND A 2.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11454018 ↗MalfunctionDec 8, 2020Activation Failure; Activation Failure
IT WAS REPORTED THAT THE DISTAL END OF THE PIPELINE HAD TROUBLE OPENING, AND THE PROXIMAL END OF THE 5MM X 18MM DID NOT OPEN AT ALL EVEN WHEN REMOVED, ONLY WHEN THE DEVICE WAS FORCED OFF THE WIRE THAT IT OPENED. THE 5MM X 20MM WAS STILL IN THE CATHETER. THE PIPELINES WERE NOT POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE REHEATED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINES WERE REHEATED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. IT WAS NOTED THE PIPELINES WERE USED FOR A CC FISTULA WHICH WAS NOT AN APPROVED INDICATION. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN CC FISTULA AT THE LEFT INTERNAL CAROTID ARTERY WITH A DISTAL LANDING ZONE OF 4.7MM AND A PROXIMAL LANDING OF 5.2MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE ANGIOGRAPHIC RESULT POST PROCEDURE INDICATED THAT THE 5MM X 16MM PIPELINE WORKED. THE PATIENT'S MEDICAL HISTORY INCLUDED A PREVIOUS TRAUMA (CAR ACCIDENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10971713 ↗MalfunctionJul 24, 2020Activation Failure; Activation Failure
ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING THE PROCEDURE THE PIPELINES WERE BEING PLACED IN A VESSEL BEND WHEN THEY FAILED TO OPEN. ATTEMPTS TO OPEN THE DEVICES WERE MADE WITH RESHEATHING AND ATTEMPTING TO OPEN IN OTHER VESSELS BUT ATTEMPTS WERE STILL UNSUCCESSFUL. THE PROCEDURE COULD NOT BE COMPLETED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10320085 ↗MalfunctionMay 14, 2020Activation Failure; Activation Failure
ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE WAS INITIALLY OPENED IN THE STRAIGHTENED SEGMENT BELOW THE TERMINUS THEN DRAGGED BACK TO ANEURYSM FOR DEPLOYMENT WHICH HAD MANY BENDS. MULTIPLE ATTEMPTS WERE MADE TO OPEN THE DISTAL SEGMENT OF THE PIPELINE FLEX INCLUDING RECONSTRAINING TO THE PTFE SLEEVE SEGMENT , VIGOROUS LOADING AND UNLOADING FLATTENED PIPE SEGMENT( WAGGING), CENTERING PHENOM 27 IN MIDDLE OF VESSEL DURING DEPLOYMENT, AND REPOSITIONING THE PIPELINE FLEX SEGMENT BEFORE THE VESSEL BEND. THERE WAS NO UNUSUAL RESISTANCE FELT DURING DEPLOYMENT OF THE PIPELINE FLEX DURING DELIVERY OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10057157 ↗InjuryJan 23, 2020Break; Break
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE BROKE OFF IN THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, CAVERNOUS RIGHT ICA ANEURYSM WITH A MAX DIAMETER OF 9MM, A 5MM NECK DIAMETER, AND A LANDING ZONE OF 4.8X5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE WAS DEPLOYED IN THE M1, AND WHEN THE PHYSICIAN STARTED TO DRAG THE DEVICE BACK, THE PUSHWIRE BROKE OFF FROM THE DISTAL TIP PROXIMAL TO THE RE-SHEATHING MARKER. A SNARE WAS USED TO TRY AND RETRIEVE THE WIRE, BUT IT DIDN'T WORK. FOUR ATLAS STENTS WERE PLACED TO COVER THE WIRE FROM THE PCOM (POSTERIOR COMMUNICATING ARTERY) AND INTO THE CAVERNOUS SECTION PAST THE PIPELINE BUT BEFORE THE ANEURYSM. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND IT WAS STATED THE PATIENT WAS DOING WELL. ANCILLARY DEVICES INCLUDE A 6FR SHUTTLE SHEATH, PHENOM 027 MICROCATHETER, PHENOM PLUS GUIDE CATHETER, AND A SYNCHRO 2 GUIDEWIRE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9622387 ↗MalfunctionNov 11, 2019Activation Failure; Activation Failure
MEDTRONIC RECEIVED REPORT THAT A PIPELINE FLEX DEVICE 5.00 X 18 WAS ATTEMPTED TO BE DEPLOY IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE DEVICE FAILED TO OPEN UPON REACHING THE LANDING ZONE. THE DEVICE WAS REMOVED AND A SECOND DEVICE WAS OPENED AND SUCCESSFULLY PLACED. NO PATIENT ADVERSE EVENT AS A RESULT. A CONTINUOUS FLUSH WAS USED DURING THE DELIVERY OF THE PED. THE DISTAL SECTION OF THE PED FAILED TO OPEN. THE DEVICES WERE EACH PREPARED AND USED PER THE INSTRUCTIONS FOR USE. THE PATIENT ANATOMY WAS MODERATED IN TORTUOSITY. NO RESISTANCE WAS FELT WHEN THE PED WAS ADVANCED. THE PED WAS RESHEATHED ONE TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9303090 ↗MalfunctionApr 10, 2017Activation Failure; Activation Failure
MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF AN ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) TWO PIPELINE DEVICES WOULD NOT FULLY OPEN DISTALLY. THE FIRST PIPELINE (PED-500-20) WAS ATTEMPTED AND IT REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO RECAPTURE AND REDELIVER. MORE THAN 50 % OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES AND REMOVED TOGETHER WITH THE MICROCATHETER. A NEW PIPELINE (PED-500-18) WAS USED AND REQUIRED BALLOON ANGIOPLASTY IN ORDER TO GET THE DEVICE TO FULLY OPEN AT THE DISTAL END. AS, THE DISTAL SEGMENT OF THE PIPELINE WAS POSITIONED IN A BEND. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. NO PATIENT INJURY WAS REPORTED. THE ANEURYSM WAS SACCULAR WITH A MAX DIAMETER OF 8 MM AND THE NECK DIAMETER WAS 5 MM. THE DISTAL LANDING ZONE WAS 3.8 MM AND THE PROXIMAL WAS 4.8 MM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6478537 ↗
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-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-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-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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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