PIPELINE PED-375-35 (UDI 00847536015753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536015753), received between Nov 29, 2018 and Jan 27, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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

1. 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE MIDDLE OF THE PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 18.7MM, AND THE NECK DIAMETER WAS 12.1MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 2.83MM DISTAL AND 3.47MM PROXIMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WHICH WAS 7.3MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AT A ROUTINE LEVEL. IT WAS REPORTED THAT THE PIPELINE COULD NOT BE PUSHED FORWARD OR WITHDRAWN. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE BLOOD FLOW HAD SLOWED DOWN. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A COOK 6 SHEATH, NAVIEN 5F GUIDE CATHETER, AND SYNCHRO 2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367879 ↗
• MalfunctionJul 6, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY AND CAVERNOUS SINUS SEGMENT. THE MAX DIAMETER AND NECK DIAMETER WERE 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.2MM DISTAL AND 3.8MM PROXIMAL. DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED, AND THE PRU LEVEL WAS SAID TO BE THE STANDARD ACHIEVEMENT PRIOR TO THE SURGERY. IT WAS REPORTED THAT INITIALLY THE TIP OF THE PIPELINE COULD NOT BE OPENED. AFTER THE TIP WAS OPENED BY MASSAGING, THERE WAS A KINK AT THE BEND OF THE TYPE IV CAVERNOUS SINUS AND THE MIDDLE OF THE PIPELINE COULD NOT BE OPENED. THE PROXIMAL AND MIDDLE SECTIONS OF THE PIPELINE HAD BEEN POSITIONED IN A BEND, AND MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN 2 TIMES, AND NO OTHER STEPS TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PENUMBRA NEURONMAX 6F088 GUIDE CATHETER, J <(>&<)>J CERENOVU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124617 ↗
• MalfunctionAug 28, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE AND THE TIP OF THE WIRE WAS BROKEN. IT WAS REPORTED THAT AFTER HYDRATION THE PIPELINE COULD NOT BE TRANSPORTED TO THE MICROCATHETER. AFTER SEVERAL ATTEMPTS, IT WAS FOUND THAT THE DEVELOPING GUIDE WIRE AT THE TIP OF THE STENT WAS BROKEN. THE PIPELINE WAS REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PATIENT¿S PRU LEVEL WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED IN THE RIGHT INTERNAL CERVICAL ARTERY. THE MAX DIAMETER WAS 15 MM. THE NECK WAS 5 MM. THE ARTERY LANDING ZONE WAS 3 MM DISTAL AND 3.5 MM PROXIMAL. THE VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10469072 ↗
• InjuryMay 26, 2020Break; Material Deformation; Activation Failure; Physical Resistance/Sticking; Break; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION: THE SEPARATED PIPELINE PORTIONS WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THE MARKSMAN CATHETER WAS DAMAGED. THE DEVICES ARE EXPECTED TO BE RETURNED. HOWEVER, THE DEVICES ARE CURRENTLY WITH THE DISTRIBUTOR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10089580 ↗
• InjuryMay 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE BROKE DURING ATTEMPT TO WITHDRAW. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 11MM AND THE NECK DIAMETER WAS 9MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER THE PIPELINE WAS SUCCESSFULLY IMPLANTED, THE CATHETER WAS MADE TO GO SUPERIOR TO WITHDRAW THE GUIDEWIRE. HOWEVER, THE CATHETER WAS UNABLE TO MOVE UPWARD AND HAD TO BE ADJUSTED. WHILE WITHDRAWING THE CATHETER, THE MARKING POINT AT THE PROXIMAL SIDE OF THE GUIDEWIRE BROKE. THE PROXIMAL MARKING POINT AND THE GUIDEWIRE THEN COULD NOT BE WITHDRAWN AND REMAINED IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10035609 ↗
• MalfunctionNov 29, 2018Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT, ONCE IN PLACE, THE PHYSICIAN ATTEMPTED TO OPEN THE PIPELINE DEVICE BUT IT WOULD NOT OPEN AND COULD "NOT BE FULLY ATTACHED." THE PHYSICIAN CONTINUED TO RELEASE THE DEVICE UP UNTIL THE MIDDLE OF THE NECK BUT THE TIP STILL WOULDN'T FULLY OPEN, WITH THE ENTIRE PIPELINE SYSTEM EVENTUALLY SLIPPING INTO THE ANEURYSM SAC BECAUSE THE PIPELINE TIP WAS NOT FULLY ATTACHED. AS A RESULT THE PIPELINE WAS WITHDRAWN AND REPLACED WITH ANOTHER OF THE SAME MODEL, ALLOWING THE OPERATION TO BE COMPLETED AS INTENDED. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 29MM AND A NECK DIAMETER OF 19MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND POST PROCEDURE ANGIOGRAPHIC IMAGING SHOWED BLOOD STASIS. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8118324 ↗

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-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-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-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