PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000284282), received between Aug 21, 2024 and Apr 29, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE THAT FAILED TO OPEN IN THE MID-SEGMENT OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6MM AND A 6MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 3.5MM DISTAL AND 3.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT WAS POST PROCEDURE, "FOLLOWING STENT REPLACEMENT, SIGNIFICANT CONTRAST STAGNATION WAS OBSERVED IN THE ANEURYSM, WITH NO VASCULAR LOSS DETECTED. NO IMAGES ARE AVAILABLE FOR REVIEW. IT WAS REPORTED THAT STENT DELIVERY WAS STARTED, THE PHENOM27 (P27) MICROCATHETER WAS POSITIONED AT THE M1 SEGMENT, AND STENT DELIVERY WAS STARTED. AS THE PATIENT¿S M1 SEGMENT WAS NOT STRAIGHT, THE CUSTOMER DECIDED TO DEPLOY THE STENT IN SITU. THE P27 MICROCATHETER WAS RETRACTED, AND DEPLOYMENT OF THE TIP OF THE STENT WAS INITIATED. THE STENT TIP GRADUALLY OPENED BUT INITIALLY APPEARED SOMEWHAT ROD-SHAPED. WITH ADVANCEMENT OF THE STENT, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033278 ↗
• MalfunctionFeb 3, 2026Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE STENT FAILED TO OPEN DUE TO A KINK OCCURRING IN THE MIDDLE SEGMENT, WHICH PREVENTED DEPLOYMENT. THE CAUSE OF THE STENT KINK WAS NOT CONFIRMED; HOWEVER, THE CUSTOMER REPORTED VESSEL TORTUOSITY AND STENT DEFORMATION. THE SECTION OF THE PIPELINE THAT DID NOT OPEN WAS THE MIDDLE PORTION, AND THIS SECTION HAD BEEN PLACED IN A VESSEL BEND WHEN THE FAILURE OCCURRED. MULTIPLE ATTEMPTS WERE MADE TO OPEN THE PIPELINE, BUT THESE ATTEMPTS WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247520 ↗
• MalfunctionJan 5, 2026Break; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PHENOM 27 MICROCATHETER WAS POSITIONED, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS ADVANCED, BUT THERE WAS RESISTANCE DURING STENT DELIVERY. WHILE WITHDRAWING THE STENT, THE STENT PROTECTIVE SLEEVE, ALONG WITH THE TIP RADIOPAQUE COIL, WAS DISCONNECTED FROM THE PUSH GUIDEWIRE. THE STENT WAS REPLACED WITH A MEDTRONIC STENT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.7 MM DISTALLY AND 3.9 MM P ROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD STASIS WITHIN THE ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). ANCILLARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959015 ↗
• MalfunctionNov 4, 2025Difficult or Delayed Positioning; Retraction Problem; Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Difficult or Delayed Positioning; Retraction Problem; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Inflammation

  MAUDE report 23469080 ↗
• MalfunctionFeb 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER THE DOCTOR RETRIEVED THE PIPELINE ONCE DURING THE OPERATION, ENCOUNTERED RESISTANCE WITH THE PHENOM WHEN PUSHING IT AGAIN. FAILED AFTER ANOTHER ATTEMPT, BUT SUCCEEDED AFTER REPLACING THE CATHETER AND STENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PATIENT WAS BEING TREATED FOR A SACCULAR, UNRUPTURED ANEURYSM IN THE COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 5MM. THE LANDING ZONE WAS 10MM DISTALLY AND 12MM PROXIMALLY. VESSEL TORTUOSITY WAS MINIMAL, ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE PROXIMAL END OF THE CATHETER. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319118 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED ANCILLARY DEVICES USED RIST RADIAL ACCESS 079; OTHER: RIST RADIAL ACCESS SIM2. PRIMARY INTRACRANIAL SUPPORT CATHETER: NAVIEN 058. THE PATIENT WAS BEING TREATED FOR A SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) C6 TERMINUS.

  Patient problems: Dizziness; Visual Disturbances

  MAUDE report 20032183 ↗
• MalfunctionAug 21, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE DID NOT OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012608 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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