PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000284435), received between Jan 20, 2023 and Jan 27, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS C7 DISSECTING ANEURYSM WITH 5MM DIAMETER. NO PROBLEMS WERE REPORTED WITH THE PHENOM 27 MICROCATHETER. THE MAIN ALLEGATION REGARDING THE PED2 STENT WAS THAT IT COULD NOT BE OPENED, SPECIFICALLY AT THE DISTAL SECTION, ALTHOUGH IT WAS NOT PLACED IN A VESSEL BEND. MULTIPLE ATTEMPTS WERE MADE TO OPEN THE STENT, BUT THEY WERE UNSUCCESSFUL, AND THE CAUSE OF THE FAILURE WAS DETERMINED TO BE A STENT ISSUE. WHEN USING THE ECHELON 10 CATHETER WITH THE COIL, RESISTANCE WAS ENCOUNTERED IN THE DISTAL SECTION, BUT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE INSTRUCTIONS FOR USE WERE STRICTLY FOLLOWED, AND THERE WAS NO KINK OR DAMAGE OBSERVED TO EITHER THE COIL OR THE CATHETER AFTER REMOVAL. THE CAUSE OF THE RESISTANCE WAS DETERMINED TO BE A DEVICE ISSUE. BOTH ECHELON 10 MICRO CATHETERS HAD AN ISSUE WITH THE COIL. A TOTAL OF FIVE COILS WERE USED DURING THIS PROCEDURE, ONE OF WHICH COULD NOT PASS THROUGH. ANCILLARY DEVICES INCLUDE A ECHELON 190-5091-150/0230721934, FIVE COILS APB-3.5-10-3D-ES/229241635, APB-2-4-3D-ES/230393655, APB-2.5-4 -3D-ES/229241592, APB-1.5-2-3D-ES/229728836, APB -1.5-2-3D-ES/230592114.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192554 ↗
• MalfunctionAug 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, THE PIPELINE EMBOLIZATION DEVICE 4.25MM X 16MM FAILED TO OPEN AFTER MULTIPLE ATTEMPTS AND TECHNIQUES WERE USED. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN, AND THE DEVICE WAS RESHEATHED MORE THAN TWO TIMES. THE PIPELINE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER PIPELINE DEVICE, WHICH OPENED SUCCESSFULLY. ANGIOGRAPHIC IMAGING CONDUCTED POST PROCEDURE SHOWED A CLEAR AND SUCCESSFUL RESULT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873739 ↗
• MalfunctionMar 11, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS SUCCESSFULLY WORKING AFTER THE SURGERY. THE STENT DISPLACEMENT WAS IDENTIFIED BY THE DOCTOR A YEAR LATER DURING A FOLLOW UP EVALUATION. THERE WAS MIGRATION AFTER DEPLOYMENT. THE CAUSE OF THE MIGRATION IS UNKNOWN. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION. FULL WALL APPOSITION WAS ACHIEVED. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT. AFTER THE SURGICAL PROCESSES, THE ANGIOGRAPHIC RESULTS WERE FAVORABLE. THE ADVERSE RESULTS WERE IDENTIFIED ON THE FOLLOW UP EVALUATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN MENTIONED THE EVENT OCCURRED AFTER THE DSA

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575411 ↗
• MalfunctionJan 7, 2025Unintended Ejection; Retraction Problem; Unintended Movement; Physical Resistance/Sticking; Unintended Ejection; Retraction Problem; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS DETERMINED TO BE STENT DISLODGEMENT. RESISTANCE OCCURRED IN THE TIP END OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED. THERE WERE NOT MULTIPLE PIPELINE DEVICES BEING USED WHEN MOVEMENT OCCURRED. FRICTION OR DIFFICULTY OCCURRED DURING DELIVERY OR POSITIONING AND THE DEVICE JUMPED DURING DEPLOYMENT. THE TIP OF THE CATHETER MOVED DURING DEPLOYMENT. PREMATURE DEPLOYMENT OCCURRED WHEN THE STENT PASSED THROUGH THE TUMOR NECK. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THERE WAS RESISTANCE DURING RESHEATHING INTO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095772 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED DIZZINESS WITH MEAN ARTERIAL PRESSURE IN THE 50S (LOW) WITH HEART RATE IN THE 40S. NO HEMATOMA. HGB WAS LOW. SITE DID NOT REPORT ANY SPECIFIC CAUSE FOR THE ORTHOSTASIS HYPOTENSION.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension

  MAUDE report 20585110 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED BILATERAL LOWER EXTREMITY EDEMA. CEC ADJUDICATED AS POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 20417319 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE VESSEL TORTUOSITY WAS NORMAL. THE CAUSE OF DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298026 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH 2 PED2 PIPELINES HAD COMPLICATIONS. SOURCE DOCUMENT REPORTED THE FOLLOWING FINDINGS ON THE DAY OF INDEX HOSPITAL DISCHARGE: - HEMATURIA AND POSITIVE TEST FOR UTI. ANTIBIOTIC WAS GIVEN - RASH ON ABDOMEN AND BACK POSSIBLY DUE TO DRUG REACTION. STEROID CREAM WAS PRESCRIBED - FEMORAL DISSECTION: POSSIBLY ACCESS SITE, CONSERVATIVE FOLLOW UP ATRIAL FIBRILLATION WHICH WAS RESOLVED AND MEDICATION WAS NOT PRESCRIBED AT THIS MOMENT DUE TO RISK OF HEMORRHAGE. PLANNED TO WAIT FOR 2 WEEKS AFTER STROKE EVENT ON (B)(6) 2024. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Atrial Fibrillation; Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Skin Discoloration; Vascular Dissection

  MAUDE report 19085665 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED CEC ADJUDICATION 22JAN2025: CAUSALLY RELATED TO THE STUDY DEVICE.

  Patient problems: Aphonia; Hemorrhagic Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion; Ptosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 18964090 ↗
• MalfunctionMar 15, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED ICA WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4.2 MM, NECK DIAMETER 4.7 MM. LANDING ZONE DIMENSIONS: DISTAL 3.29 MM AND PROXIMAL 3.7. THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. AFTER A FEW ATTEMPTS OF DEPLOYING THE DEVICE FAILED TO OPEN DISTALLY AND EVEN IN THE MIDDLE SECTION. THE HEALTHCARE PROVIDER REMOVED THE DEVICE ONCE IT BEGAN TO "FISH MOUTH." IN THE SECOND ATTEMPT TO DEPLOY A PIPELINE, THE HEALTHCARE PROVIDER USED A 4.25 X 14 AND EXCHANGED THE PHENOM 27 MICROCATHETER FOR A NEW PHENOM 27. THIS TIME, THE HEALTHCARE PROVIDER OPENED HALF OF THE DEVICE IN THE M1, RECAPTURED HALFWAY AND THEN DRAGGED IT BACK TO THE DISTAL SEGMENT. THE REST OF THE DEVICE OPENED SMOOTHLY AROUND THE BEND. THERE WAS SOME DIFFICULTY RECAPTURING THE SECOND DEVICE THAT RESULTED IN THE DELIVERY WIRE TO BE COMPROMISED. THE PUSHWIRE/CAPTURE COIL WAS STUCK DURING RETRACTION AT THE DISTAL END OF THE STENT. NO CATHETER OR PUSHWIRE DAMAGE WAS NOTED. THE CAPTURE COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914204 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT EXPERIENCED SYMPTOMATIC ANEMIA FOLLOWING A PIPELINE IMPLANT, AND WAS HOSPITALIZED FROM (B)(6) 2023 TO (B)(6) 2023. THE PATIENT PRESENTED WITH DIZZINESS, DYSPNEA ON EXERTION, AND FATIGUE. THEY WERE GIVEN A LACTATED RINGER'S (LR) BOLUS AND SEEN BY THE GI TEAM. THEY UNDERWENT SCOPE WHICH REVEALED NORMAL ESOPHAGOGASTRODUODENOSCOPY (EGD) AND NO ACTIVE BLEE D. VIDEO CAPSULE ENDOSCOPY (VCE) WAS ATTEMPTED, BUT THE PATIENT GREW RESTLESS. THE EVENT RECOVERED/RESOLVED WITH SEQUELAE ON (B)(6) 2023. THE EVENT WAS NOT THE RESULT OF A DEVICE DEFICIENCY, AND WAS NOT A NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DISEASE UNDER STUDY, THE DEVICE, THE PROCEDURE, OR ANTIPLATELET MEDICATION. CEC ASSESSED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND ANTIPLATELET MEDICATION. THE PATIENT HAD UNDERGONE TREATMENT FOR A SIDEWALL, SACCULAR ANEURYSM LOCATED IN THE C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 5MM, THE DOME HEIGHT WAS 4.5MM, THE DOME WIDTH WAS 4.4MM, AND THE NECK SIZE WAS 2MM. THE PARENT ARTERY DIAMETER WAS 4.1MM DISTAL AND 3.8MM PROXIMAL. THE PIPELINE WAS SUCCESSFUL

  Patient problems: Anemia; Chest Pain; Dizziness; Fatigue; Respiratory Insufficiency

  MAUDE report 18452212 ↗
• MalfunctionJan 20, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE WAS PLACED IN THE VESSEL WHERE IT DIALED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214791 ↗

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-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