PIPELINE PED-450-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536016415), received between Oct 30, 2019 and Dec 17, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME LOCKED UP IN THE DISTAL SEGMENT OF THE PHENOM MICROCATHETER DURING DEPLOYMENT. THE PHYSICIAN WAS UNABLE TO PUSH THE STENT FORWARD OR RECAPTURE, AND THE STENT WAS PARTIALLY DEPLOYED. THE SLACK WAS RELEASED IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE DEVICE WAS STILL STUCK. WHEN RESHEATHING WAS ATTEMPTED, THE DEVICE LOCKED UP. AS A RESULT, BOTH THE PIPELINE AND MICROCATHETER WERE REMOVED TOGETHER AS A UNIT. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR THE PUSHWIRE. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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. POST-PROCEDURE ANGIOGRAPHY SHOWED SUCCESSFUL PIPELINE DEPLOYMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A NEURON MAX 6F 088, NAVIEN GUIDE CATHETER, PHENOM MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032883 ↗
• MalfunctionAug 21, 2020Break; Activation Failure; Break; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE MIDDLE SEGMENT OF THE PIPELINE FLEX DID NOT OPEN AND THE DISTAL PUSHWIRE SEPARATED DURING A PROCEDURE. THE MIDDLE OF THE PIPELINE FLEX FINALLY OPENED AS THE PHYSICIAN MANIPULATED A SNARE THROUGH IT TO AN ATTEMPT TO CAPTURE THE SEPARATED DISTAL PUSHWIRE. THE SEPARATED DISTAL PUSHWIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. POST PROCEDURE IMAGING REVEALED A DISSECTION OF THE OPHTHALMIC ARTERY WITH NON-RESTRICTIVE ANTEGRADE FLOW. THE PIPELINE DEVICE WAS PATENT AND APPOSED, BUT PROXIMAL TO THE TARGET SEGMENT. IMMEDIATELY ONE DAY POST PROCEDURE, THE PATIENT WAS STABLE WITH NORMAL EXAM FINDINGS. THE HOSPITAL POLICY DICTATES THEY WILL RETAIN ALL PRODUCTS USED DURING THE PROCEDURE. PRIOR TO THE EVENT, A PHENOM 27 WAS IN PLACE IN DISTAL M1 WITH SOFIA EX AS INTERMEDIATE SUPPORT CATHETER AND INFINITY LS AS THIRD COMPONENT OF TRIAXIAL SETUP. NO DIFFICULTY PUSHING WIRES AND CATHETERS PAST GENUS. THE PIPELINE FLEX WAS PREPPED PER IFU, ADVANCED SMOOTHLY THROUGH THE PHENOM, AND PARTIALLY DEPLOYED IN M1. THE DISTAL END OPENED AS SYSTEM WAS PULLED BACK INTO ICA TO TREATMENT SEGMENT. THE DISTAL END FULLY OPENED AS MORE DEVICE WAS PUSHED OUT UNTIL IT CAME ARO

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

  MAUDE report 10439147 ↗
• MalfunctionJul 9, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PUSHWIRE DID NOT SEPARATE OR BREAK. RESISTANCE WAS NOT FELT WHEN THE PIPELINE WAS ADVANCED OR RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10251150 ↗
• MalfunctionDec 3, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX INCOMPLETE OPENING DURING A PROCEDURE. INFORMATION THAT PIPELINE FLEX DEVICE FLATTENED AND STRETCHED DURING THE PROCEDURE. THE PIPELINE DID NOT OPEN. FISTULA HAPPENED DURING ADVANCEMENT OF THE NAVIEN AND PHENOM 027 IN AN ATTEMPT TO OPEN THE FLATTENED AREA. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR AN UNRUPTURED AMORPHOUS ANEURYSM LOCATED IN RIGHT INTERNAL CAROTID ARTERY (ICA) LANDING ZONE DISTAL 3.2MM PROXIMAL 4.7MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT PIPELINE WAS PREPPED PER IFU, NO ISSUES DURING DEPLOYMENT. PIPELINE DID APPEAR TO BE STRETCHING BEFORE DETACHMENT AND WAS DETACHED OVER A BEND WHICH RESULTED IN FLATTENING OF THE DEVICE. THE PHYSICIAN ADVANCED A GUIDE CATHETER AND MICROCATHETER TO OPEN THE FLATTENED AREA. A RUN WITH CONTRAST REVEALED A FISTULA THAT THE PHYSICIAN BELIEVES WAS CATHETER INDUCED. THE PHYSICIAN DECIDED TO ¿SACK¿ THE VESSEL AS THE RIGHT ICA ON IMAGING WAS BEING WELL FED FROM CONTRALATERAL FLOW. RIGHT ICA WAS SACRIFICED; THE PATIENT¿S CONTRALATERAL FLOW WAS FEEDING RIGHT CIRCULATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9407255 ↗
• MalfunctionNov 22, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX PUSHWIRE BROKE PROXIMAL TO PROXIMAL BUMPER WHILE RESHEATHING. THE WIRE WAS REMOVED AND PIPELINE REMAINED LODGED IN THE MICRO CATHETER. THE MICRO CATHETER AND PIPELINE WERE REMOVED AS A SYSTEM. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR AN UNRUPTURED INTERNAL CAROTID ARTERY ANEURYSM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SATISFACTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366520 ↗
• MalfunctionNov 17, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT PIPELINE FLEX PUSHWIRE SEPARATED. THE PIPELINE FLEX DEVICE WAS SUCCESSFULLY DEPLOYED WITH GOOD WALL APPOSITION AND GOOD NECK COVERAGE; UPON RETRIEVING THE DELIVERY WIRE OF THE PIPELINE DEVICE, IT WAS NOTICED THERE WAS NO MOVEMENT OF THE TIP COIL; IT WAS ATTEMPTED AGAIN TO RETRIEVE THE WIRE. THE ENTIRE DELIVERY SYSTEM AND CATHETER WERE REMOVED, AND THE DELIVERY WIRE WAS NOTICED TO HAVE BROKEN INSIDE OF THE MICROCATHETER. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER THE IFU. THE TORTUOSITY WAS MODERATE AND APPEARED TO BE A SLIGHTLY TOUGHER TO ADVANCE THE DEVICE MORE SO THAN NORMAL. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT OPHTHALMIC, INTERNAL CAROTID ARTERY (ICA), UNRUPTURED, AMORPHOUS, ANEURYSM. THE MAX DIAMETER WAS 7MM AND NECK WIDTH OF 5MM. THE DISTAL LANDING ZONE WAS 3.96MM AND THE PROXIMAL WAS 4.43MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9333604 ↗
• MalfunctionNov 11, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT PIPELINE FLEX DID NOT OPEN IN THE DISTAL SECTION. THE PED WAS ADVANCED TO THE LANDING ZONE WITHOUT ISSUE. THE DISTAL END WAS UNSHEATHED AND WAS NOTICED TO BE NARROWED AND NOT FULLY OPEN. IT WAS ATTEMPTED TO RE-CAPTURE THE PED AND RE-DELIVER TWICE, HOWEVER, THE PED REMAINED NARROWED. THE DEVICE WAS REMOVED AND A NEW PED WAS DELIVERED SUCCESSFULLY. THE DEVICE WAS NOT PLACED IN A BEND. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO EXPAND. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. PED WAS PULLED TO THE HUB OF THE MC AND THEN REMOVED BY REMOVING THE RHV. THERE WAS PARTIAL CONTRAST FILLING OF THE ANEURYSM POST THE INTERVENTION. THE ANEURYSM WAS IN THE RIGHT OPHTHALMIC WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 5MM WITH A NECK OF 3.5MM. DISTAL LANDING ZONE WAS 3.5MM AND 4.4MM PROXIMAL. THE ANATOMY WAS SEVERE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9307598 ↗
• MalfunctionOct 30, 2019Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX PUSHWIRE SEPARATION. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED ANEURYSM. VESSEL TORTUOSITY WAS DESCRIBED AS SEVERE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS DEPLOYED. THE MICROCATHETER WAS ADVANCED BACK THROUGH THE PIPELINE FLEX DEVICE TO CAPTURE THE DELIVERY WIRE. THERE WAS STRAIN PULLING ON THE DELIVERY WIRE BACK INTO THE CATHETER. UPON CONDUCTING A RUN, IT WAS NOTICED THAT THE PIPELINE FLEX PUSHWIRE BROKE AT THE PROXIMAL BUMPER. ASPIRATION WAS STARTED THE SYSTEM WAS REMOVED. THE BROKEN PIECE WAS REMOVED. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257929 ↗

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-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-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-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