PIPELINE PED-425-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536016088), received between Nov 27, 2019 and Nov 17, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2021Retraction Problem; Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DELIVERY SYSTEM BECAME STUCK IN THE PHENOM MICROCATHETER DURING RETRACTION. THE PATIENT WAS UNDERGOING TREATMENT FOR UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT ICA. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.2MM DISTAL AND 4.2MM PROXIMAL. THE ACCESS VESSEL WAS THE LEFT ICA, WHICH WAS 4.2MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 26. IT WAS REPORTED THAT THE PIPELINE WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM. THE PHYSICIAN WENT THROUGH THE DEVICE TO CAPTURE THE DISTAL PIPELINE WIRE. RETRIEVAL WAS TOUGH, AND THE WIRE BECAME STUCK IN THE CATHETER. THE WIRE AND CATHETER WERE REMOVED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PUSHWIRE WAS NOT ROTATED DURING REMOVAL, AND THERE WAS NO DAMAGE TO THE CATHETER. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED GOOD PLACEMENT. THE PATIENT WOKE UP WITHOUT INCIDENT AND RETURNED TO BASELINE. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NAVIEN 072 GUIDE CATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833170 ↗
• MalfunctionSep 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE ONE PIPELINE EXPERIENCED RESISTANCE IN THE HUB OF THE PHENOM 27 MICROCATHETER, TWO PIPELINES DEPLOYED IN THE CATHETER HUB, AND A THIRD FAILED TO OPEN DISTALLY AND BROKE DURING RETRIEVAL. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER WAS 2.9MM, AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS WAS 3.5MM DISTAL AND 4.5MM PROXIMAL. THE ACCESS VESSEL WAS THE LEFT ICA, WHICH WAS 3.5-4.5MM IN DIAMETER. IT WAS REPORTED THAT THE FIRST PIPELINE WAS INSERTED INTO THE FIRST PHENOM 27 CATHETER AND DEPLOYED IN THE HUB DURING INSERTION. THE DEVICE WAS REMOVED. A SECOND PIPELINE WAS INSERTED INTO THE CATHETER WITH EXTRA PRECAUTION. THIS DEVICE HAD RESISTANCE IN THE CATHETER HUB AND ALSO DEPLOYED IN HUB. THE TIP OF THE SHEATH HAD BEEN SEATED SECURELY IN THE HUB. THE SECOND PIPELINE WAS REMOVED ALONG WITH PHENOM 27 CATHETER WHICH WAS REPLACED WITH A NEW PHENOM 27. A THIRD PIPELINE WAS INSERTED INTO THE CATHETER AND WAS ABLE TO BE INTRODUCED INTO CATHETER. DURING DEPLOYMENT OF THIS PIPELINE, THE DEVICE WOULD NOT OPEN DISTALLY AND HA

  Patient problems: Insufficient Information

  MAUDE report 12550180 ↗
• MalfunctionJun 3, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. AT THIS TIME, THERE WAS NOT A PROCEDURE PLAN CHANGE AS WELL AS THERE WAS NO ADDITIONAL INTERVENTION FOR TREATMENT OF THE PATIENT'S ANEURYSM PLANNED FOR THE FUTURE. THE PATIENT WAS CURRENTLY ASYMPTOMATIC.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11931902 ↗
• MalfunctionMar 31, 2020Break; Positioning Failure; Activation, Positioning or Separation Problem; Break; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PREVIOUS PIPELINE (PLI20) IMPLANTED ONE YEAR PRIOR SHOWED RESIDUAL ANEURYSM. A NEW PIPELINE (PLI10) WAS IMPLANTED, BUT EXPERIENCED RESISTANCE DURING DELIVERY. THE NEW PIPELINE WAS SUCCESSFULLY DELIVERED WITH A SLIGHT INCOMPLETE APPOSITION OF THE DISTAL SEGMENT. IT WAS INDICATED THERE WAS DIFFICULT PLACEMENT/POSITIONING. A SYNCHRO 14 WIRE WITH A J-CURVE WAS ADVANCED TO THE DISTAL SEGMENT OF THE PIPELINE, AND THE TIP OF THE WIRE APPEARED INSIDE THE MARKSMAN MICROCATHETER. THE MARKSMAN WAS REMOVED FROM THE PATIENT AND FLUSHED ON THE TABLE REVEALING THE DISTAL TIP OF THE WIRE HAD FRACTURED AT THE JUNCTION ON THE WELD JOINT. A MICROVENTION SEPTER C BALLOON WAS ADVANCED AND DILATED WHICH SUCCESSFULLY COMPLETED APPOSITION OF THEDISTAL SEGMENT OF THE PIPELINE. 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. ANCILLARY DEVICES INCLUDE A PHENOM MICROCATHETER, MARKSMAN MICROCATHETER, FUBUKI SHEATH, MICROVENTION BALLOON, SYNCHRO 14 GUIDEWIRE. ADDITIONAL INFORMATION: THE PREVIOUSLY IMPLANTED PIPELINE MODEL AND LOT NUMBERS ARE (INITIAL TREATMENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9903499 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT THE PATIENT WAS REPORTED TO HAVE BEEN TREATED FOR A POST TRAUMATIC AUTOMOBILE ACCIDENT THAT RESULTED IN A LEFT, PROXIMAL, INTERNAL CAROTID ARTERY (ICA) PSEUDOANEURYSM /FISTULA. THE PATIENT WAS INITIALLY TREATED WITH 2 FLOW DIVERTER. HOWEVER, SINCE THE BLOOD FLOW WAS STILL PRESENT THE PATIENT UNDERWENT A SECOND PIPELINE PROCEDURE ON (B)(6) 2019 AND A 3RD PIPELINE WAS IMPLANTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9580329 ↗
• InjuryNov 27, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX PUSHWIRE SEPARATION DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF A LEFT ICA, UNRUPTURED, SACCULAR ANEURYSM. THE DISTAL LANDING ZONE WAS 3.7MM AND THE PROXIMAL WAS 4.1MM. THE VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. THE PIPELINE FLEX BRAID WAS DEPLOYED WITHOUT ISSUE. DURING RECAPTURE OF THE DELIVERY SYSTEM, THE PROXIMAL BUMPER WAS POSITIONED CLOSE TO THE POSTERIOR GENU AND AS THE MICROCATHETER WAS ADVANCED, THERE WAS A NOTED SEPARATION OF THE DELIVERY WIRE AT THE PROXIMAL BUMPER. WHEN THIS WAS NOTED, THE PROXIMAL SECTION OF THE DELIVERY WIRE WAS REMOVED, LEAVING THE DISTAL PORTION IN THE VESSEL. ATTEMPTS WERE MADE TO CAPTURE THE DISTAL WIRE WITH SEVERAL SNARES WITHOUT SUCCESS. THE FINAL DECISION WAS TO DEPLOY TWO STENTS ACROSS THE ENTIRE LENGTH OF THE FREE WIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9386354 ↗

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-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-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-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