PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000284190), received between Jan 10, 2022 and Sep 28, 2026 — classified as 1 death, 1 injury, 2 malfunctions.

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

• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922188 ↗
• MalfunctionJan 2, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY, C6 SEGMENT WITH A MAX DIAMETER OF 3.4MM AND A 3.8MM NECK DIAMETER. THE LANDING ZONE WAS 3.15MM DISTALLY AND 3.6MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.1MM. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE BLOOD VESSELS WERE PATENT, BUT CONTRAST AGENT REMAINED WITHIN THE ANEURYSM. IT WAS REPORTED THAT AFTER POSITIONING THE LONG SHEATH, INTERMEDIATE CATHETER, AND STENT DELIVERY CATHETER, THE PHENOM 27 STENT DELIVERY CATHETER WAS USED TO DEPLOY THE PED2-350-25 TIP END. THE STENT WAS DEPLOYED FROM THE MIDDLE CEREBRAL ARTERY BIFURCATION, AND INITIALLY OPENED WELL. HOWEVER, REPEATED PUSH-AND-PULL ATTEMPTS FAILED TO FULLY OPEN THE STENT AT THE C7 SEGMENT (APPROXIMATELY 3.15 MM). THE MICROCATHETER WAS REINTRODUCED INTO THE STENT, AND ANOTHER ATTEMPT TO ANCHOR AND DEPLOY THE STENT WAS MADE, BUT THE TIP END OF THE STENT WAS SEVERELY DEFORMED UPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946521 ↗
• InjuryDec 30, 2025Break; Retraction Problem; Device Dislodged or Dislocated; Material Deformation; Migration; Break; Retraction Problem; Device Dislodged or Dislocated; Material Deformation; Migration

  ADDITIONAL INFORMATION RECEIVED. THE PATIENT IS CURRENTLY RECOVERING WELL FROM THE PROCEDURE, WITH ONLY MILD APHASIA PRESENT; ALL OTHER CONDITIONS ARE GOOD. THE SYMPTOMS OF CEREBRAL INFARCTION HAVE IMPROVED FOLLOWING POSTOPERATIVE PHARMACOLOGICAL TREATMENT. REGARDING VASCULAR ACCESS, THE VESSEL DIAMETER WAS MEASURED AT 2.1 MM AT THE DISTAL END AND 2.82 MM AT THE PROXIMAL END. THE CAUSE OF THE EVENT WAS IDENTIFIED AS A FRACTURE OF THE DISTAL DEVELOPMENT COIL AT THE TIP OF THE PIPELINE PUSH ROD, WHICH BROKE OFF AND WAS LEFT INSIDE THE PATIENT. NO SIGNIFICANT RESISTANCE WAS ENCOUNTERED BY THE OPERATOR WHEN RETRIEVING THE PUSH ROD WITH THE MICROCATHETER. UPON INSPECTION, A FRACTURE OF THE DISTAL DEVELOPMENT GUIDEWIRE OF THE PIPELINE WAS OBSERVED; NO KINKING, STRETCHING, OR SEPARATION WAS NOTED. THERE WAS NO MIGRATION OF THE DEVICE, AND THE PIPELINE STENT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED LOCATION AND OPENED NORMALLY. NO ADDITIONAL DEVICES OR INTERVENTIONS WERE REQUIRED FOR THE BROKEN OR DISLODGED PARTS LEFT IN THE PATIENT, AS THEY HAD REACHED BEYOND THE M2 SEGMENT AND THE VESSEL WAS TOO SMALL FOR FURTHER MANIPULATION.

  Patient problems: Foreign Body In Patient; Ischemia Stroke

  MAUDE report 23923984 ↗
• DeathJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO PIPELINE FLEX SHIELDS WERE USED WITHOUT ISSUE AND FOLLOW UP IMAGING CONFIRMED EXCELLENT PLACEMENT AND APPOSITION. AS THE SYSTEM WAS REMOVED AFTER DEPLOYMENT IT APPEARED THAT THE STRESS ON THE VESSEL CAUSED THE VESSEL TO RE-RUPTURE. AFTER THE ANEURYSM RUPTURED THE ENTIRE RIGHT SIDE OF THE ANTERIOR CIRCULATION SHUT DOWN. THE PATIENT IS DECEASED. THE PATIENT WAS BEING TREATED FOR A RUPTURED FUSIFORM ANEURYSM IN THE RIGHT A2 LOCATION. THE MAX DIAMETER WAS 2MM AND THE NECK DIAMETER WAS 20MM. THE DISTAL LANDING ZONE WAS 2.6MM AND THE PROXIMAL LANDING ZONE WAS 2.8MM. VESSEL TORTUOSITY WAS MINIMAL. THE PIPELINE WAS USED FOR A INDICATION THAT WAS NOT APPROVED: A2. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU). ANGIOGRAPHIC RESULT POST PROCEDURE; BOTH ACA AND MCA WERE COMPLETELY CLOTTED.

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 13215031 ↗

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, 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-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-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-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