PIPELINE PED-375-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536015722), received between Mar 2, 2020 and Jul 21, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.

Recalls naming this device

1. 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS STUCK. AFTER PLACING THE MARKSMAN IN THE DISTAL MIDDLE CEREBRAL ARTERY, THE PIPELINE COULD NOT PASS THROUGH THE MARKSMAN NORMALLY. DURING THE PROCESS, IT COULD ONLY BE WITHDRAWN AS A WHOLE AND IT WAS FOUND THE STENT AND CATHETER WERE STUCK. THE MARKSMAN WAS DEFORMED. AFTER RE-SELECTING A NEW MARKSMAN, IT APPEARED THE PIPELINE COULD NOT PASS THROUGH THE MARKSMAN NORMALLY. DURING THIS PROCESS, THE PRODUCT WAS REMOVED AND WAS FOUND THE STENT AND CATHETER WERE STUCK AND THE MARKSMAN WAS AGAIN DEFORMED. AFTER REPLACING THE CATHETER AND PIPELINE, THE PRODUCT WAS SUCCESSFULLY DELIVERED TO THE TARGET LOCATION AND DEPLOYED SMOOTHLY. THE RESISTANCE WAS IN THE DISTAL END. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED ANEURYSM BLOOD FLOW RETENTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 22MM AND A 9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED FOR SEVEN DAYS. ANCILLARY DEVICES INCLUDE: A COOK 6F 70CM SHEATH, A 5F115 NAVIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079171 ↗
• MalfunctionOct 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE DEVICE AND MARKSMAN MICROCATHETER THAT HARD RESISTANCE TOGETHER AND THE MARKSMAN HAD ACCORDION DAMAGE. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR WIDE-NECKED ANEURYSM IN THE CLINOID PROCEDURE OF AN INTERNAL CAROTID ARTERY. THE ANEURYSM MAX DIAMETER WAS 9.3 MM AND THE NECK DIAMETER WAS 8.7 MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). INTRAOPERATIVE PUNCTURE AND ACCESS WERE ESTABLISHED. AFTER THE MARKSMAN WAS IN PLACE, THE PIPELINE WAS INTRODUCED. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED S ALINE PER IFU AND IT WAS NOTED THE HYDRATION WAS GOOD. HOWEVER, THE PHYSICIAN OBSERVED THAT THERE WAS SIGNIFICANT RESISTANCE DURING THE DELIVERY OF THE PIPELINE AND IT COULD NOT BE PUSHED OUT THE DISTAL END OF THE MARKSMAN MICROCATHETER. AFTER REPEATED ADJUSTMENTS, THE PIPELINE STILL COULD NOT BE DELIVERED AND DEPLOYED. THE WHOLE SYSTEM WAS WITHDRAWN AND ACCORDION DAMAGE WAS OBSERVED AT THE DISTAL TIP OF THE MARKSMAN MICROCATHETER. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE. BOTH DEVICES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662225 ↗
• MalfunctionSep 27, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY OF IMPLANTATION OF BLOOD FLOW GUIDE DEVICE FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 10MM AND A 6MM NECK DIAMETER. THE LANDING ZONE WAS 3MM ON THE DISTAL END AND 3.5MM ON THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8MM. IT WAS REPORTED THAT THE SURGEON UNDERWENT THE IMPLANTATION OF THE BLOOD FLOW GUIDE DEVICE. AFTER THE PHENOM27 CATHETER WAS IN PLACE, PED-375-30 WAS DELIVERED. AFTER BEING DELIVERED IN PLACE, ENOUGH LENGTH WAS RELEASED. AFTER A SERIES OF OPERATIONS, SUCH AS INCREASING AND DECREASING LENGTH, PUSHING FORWARD AND PULLING BACK, THE HEAD END OF THE BRACKET STILL CAN'T BE HIT, SHOWING A CONE SHAPE. THE HEAD OF THE STENT STILL COULD NOT BE HIT, AND IT TOOK A TAPERED SHAPE. FROM A SAFETY POINT OF VIEW, THE ENTIRE SYSTEM WAS REMOVED, A NEW PHENOM27 CATHETER WAS REPLACED, PED-350-30 WAS DELIVERED, AND IT WAS SUCCESSFULLY RELEASED. SO COMPLAINED THAT THE PED-375-30 AND PHENOM27 CATHETERS WHICH WERE REMOVED. THE PIPELINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533396 ↗
• MalfunctionNov 18, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE WHICH BROKE DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN WHETHER OR NOT DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE POSITION OF THE STENT WAS TO BE ADJUSTED AFTER INITIAL DEPLOYMENT. WHILE RETRIEVING THE STENT, THE PUSHWIRE BROKE AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. NO FRICTION OR OTHER DIFFICULTY HAD BEEN ENCOUNTERED. IT WAS NOT SPECIFIED HOW MANY TIMES THE PUSHWIRE WAS ROTATED TO DEPLOY THE STENT. THE BROKEN SEGMENT OF THE PUSHWIRE WAS REMOVED FROM THE PATIENT USING THE MICRO-GUIDEWIRE AND MICROCATHETER. STENT ASSISTED COIL EMBOLIZATION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10864130 ↗
• MalfunctionMar 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 10MM, 6.7MM NECK DIAMETER, AND 3.0MM DISTAL, 3.5MM PROXIMAL LANDING ZONE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE COULDN'T BE PUSHED OR OPENED NORMALLY IN THE MARKSMAN CATHETER AS IT BECAME STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE, AND NO DAMAGED WAS INDICATED TO THE CATHETER OR PUSHWIRE. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9778044 ↗

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-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-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-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