MarksmanTM FA-55150-1030 (UDI 00847536026261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00847536026261), received between Nov 22, 2017 and Aug 17, 2026 — classified as 16 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (72 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Integrity Problem

  Additional information was received reporting that the patients vessel tortuosity was normal. The patient is recovering good. No patient symptoms or further complications were reported as a result of this event. The Pipeline had not been placed in a vessel bend when it failed to open. No additional steps or other devices were attempted to open the Pipeline. The inner liner coating was not observed to be from the Marksman catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278788 ↗
• MalfunctionMay 6, 2026Retraction Problem; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AMORPHOUS, UNRUPTURED MULTIPLE ANEURYSMS AT THE LEFT C7 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.4 MM DISTALLY AND 4.15 MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT THE MIDDLE SEGMENT OF THE PED-425-18 STENT FAILED TO OPEN AND REMAINED UNABLE TO OPEN DESPITE REPEATED ATTEMPTS. ANOTHER PED-400-20WAS USED, BUT THE DISTAL TIP END OF THE SECOND STENT FAILED TO OPEN, AND THE REST OF THE STENT COULD NOT BE RETRIEVED. IT HAD TO BE WITHDRAWN . THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD FLOW WAS UNOBSTRUCTED, WITH SIGNIFICANT CONTRAST STAGNATION WITHIN THE ANEURYSM. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A U-TRACK 5F SHEATH, MARKSMAN MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104534 ↗
• MalfunctionMay 4, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A MARKSMAN, ECHELON, AND PHENOM THAT ENCOUNTERED RESISTANCE WITH A PIPELINE THAT ALSO FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 1.8MM DISTAL AND 2.3MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE FEMORAL ARTERY WAS THE ACCESS VESSEL WITH A 8-9MM DIAMETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL MET THE STANDARD. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS A MIDDLE CEREBRAL ARTERY M2 SEGMENT ANEURYSM. IT WAS REPORTED THAT THE OPERATOR PLANNED TO PARTIALLY DEPLOY THE PED, THEN PLACE COILS, AND FINALLY FULLY DEPLOY THE PED. AFTER ANGIOGRAPHY, A NAVIEN WAS ADVANCED. THE MARKSMAN WAS DELIVERED FIRST; AFTER THE MICROCATHETER REACHED THE M1 SEGMENT, RESISTANCE INCREASED. THE OPERATOR OVERCAME THE RESISTANCE AND CONTINUED ADVANCING THE MICROCATHETER UNTIL IT WAS IN POSITION. THEN THE OPERATOR STARTED TO DELIVER ECHELON. A 250-18 STENT WAS THEN SELECTED FOR DEPLOYMENT. THE TIP END OPENED SMOOTHLY AND WAS ANCHORED. THE STENT WAS FURTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073109 ↗
• MalfunctionMar 31, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE ENCOUNTERED RESISTANCE IN A MARKSMAN CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 8 MM AND A 5 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4 MM AND PROXIMAL: 4.3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL AND ALSO NOTED NORMAL. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT PIPELINE 4.50-35 WAS STUCK INSIDE MARKSMAN MICROCATHETER AND REFUSED TO BE REMOVED FROM OR OUTSIDE THE MARKSMAN. IT WAS REPORTED THE PIPELINE WAS STUCK (LOCKED UP) IN THE CATHETER OR RESISTANCE IN THE MIDDLE OF THE CATHETER OCCURRED. IT WAS REPORTED THE MARKSMAN AND THE PIPELINE WERE STUCK TOGETHER WERE COULD NOT BE DETACHED. IT WAS REPORTED THE PIPELINE WAS NOT ABLE TO OPEN. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE BECAME STUCK IN THE MIDDLE SECTION DURING DEPLOYMENT. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT IT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742810 ↗
• MalfunctionMar 23, 2026Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. ¿THE PROXIMAL END OF THE STENT MICROCATHETER BROKE¿ WAS CLARIFIED TO MEAN THAT THE CATHETER BROKE AT THE PROXIMAL END. THE BREAK WAS SUSPECTED TO BE DUE TO VASCULAR TORTUOSITY AND EXCESSIVE TENSION. NO CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE WERE IDENTIFIED. THE RESISTANCE OCCURRED IN THE PROXIMAL PORTION OF THE CATHETER. NO DAMAGE TO THE PIPELINE PUSHWIRE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669656 ↗
• MalfunctionMar 23, 2026Retraction Problem; Deformation Due to Compressive Stress; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO THE ACCESS PATH BEING EXCESSIVELY TORTUOUS, AND MICROCATHETER DAMAGE RESULTING IN STENT DAMAGE. THE STENT COULD NOT BE RETRIEVED INTO THE MICROCATHETER. DURING DELIVERY THE OPERATOR REPORTED THAT THERE WAS INCREASED RESISTANCE WHICH MADE ADVANCEMENT DIFFICULT. THE RESISTANCE OCCURRED AT THE DISTAL SECTION OF THE CATHETER. IT WAS STATED THAT THE VESSEL WAS TORTUOUS, AND THE CAVERNOUS SINUS WAS TYPE IV. THE OVERALL PROCEDURE WAS COMPLETED WITH A A NEW SYSTEM BEING USED INSTEAD, AND THE MICROCATHETER BEING REPLACED WITH A PHENOM 2. IT WAS CLARIFIED THAT PREVIOUSLY REPORTED "ACCORDION-LIKE DEFORMATION WAS OBSERVED AT THE DISTAL END." WAS REFERRING TO CATHETER DAMAGE DUE TO THE ELONGATION OF THE DISTAL SEGMENT OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664909 ↗
• MalfunctionMar 19, 2026Retraction Problem; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED. AFTER REMOVING THE STENT DELIVERY GUIDEWIRE TOGETHER WITH THE MICROCATHETER, THE ACCESS ROUTE WAS RE-ESTABLISHED AND THE SUBSEQUENT PROCEDURAL STEPS WERE COMPLETED TO FINISH THE PROCEDURE. THERE WERE NO CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE OR IRREGULAR SHAPE THAT WERE IDENTIFIED. IT WAS CLARIFIED THAT "IRREGULAR SHAPE" MEANS THAT CURVATURE AND DEFORMATION WERE OBSERVED AT THE DISTAL END OF THE MICROCATHETER. NO SHAPING HAD BEEN PERFORMED. THE CATHETER WAS CONTINUOUSLY FLUSHED THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639214 ↗
• MalfunctionFeb 6, 2026Retraction Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278336 ↗
• MalfunctionFeb 5, 2026Retraction Problem

  ADDITIONAL INFORMATION RECEIVED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271936 ↗
• MalfunctionJan 23, 2026Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS DIFFICULTY DURING DELIVERY, AS THE PIPELINE COULD NOT BE PUSHED OUT OF THE MARKSMAN CATHETER. RESISTANCE WAS ENCOUNTERED IN THE DISTAL SEGMENT OF THE CATHETER. THE CATHETER WAS FLUSHED AND FULLY HYDRATED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161199 ↗
• InjuryJan 13, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD MULTIPLE INTRACRANIAL ANEURYSMS OF THE RIGHT INTERNAL CAROTID ARTERY, INCLUDING A LARGE 10MM ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY SEGMENT AND A SMALL 4MM ANEURYSM AT THE OPHTHALMIC ARTERY SEGMENT. THE OPERATOR PLANNED TO IMPLANT A PIPELINE FOR TREATMENT. DURING THE PROCEDURE TO ESTABLISH ACCESS, IT WAS FOUND THAT THE MICROCATHETER COULD NOT ENTER THE LUMEN OF THE NAVIEN DUE TO SIGNIFICANT RESISTANCE. AFTER REPLACING WITH A NEW ONE, IT WENT THROUGH SUCCESSFULLY. THE MARKSMAN MICROCATHETER WAS POSITIONED, AND A PED-450-30 WAS DELIVERED TO THE DISTAL END OF THE MICROCATHETER. HOWEVER, THE STENT COULD NOT BE CAME OUT DESPITE BEING ABLE TO BE RETRIEVED. MULTIPLE ATTEMPTS WERE MADE WITHINCREASED PUSHING FORCE, BUT THE PROBLEM PERSISTED. SUBSEQUENTLY, POSSIBLY DUE TO REPEATED FORCEFUL MANIPULATION, THE ANEURYSM SUDDENLY RUPTURED DURING THE PROCEDURE. THE OPERATOR STATED THAT THE STENT HAD A QUALITY ISSUE AND WOULD NOT BE CHARGED FOR IT. THE DEVICE WAS STUCK (LOCKED UP) IN THE CATHETER/RESISTANCE IN THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PIPELINE BECAME STUCK IN THE DISTAL SECTION OF THE CA

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 24060658 ↗
• MalfunctionJan 13, 2026Retraction Problem; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN INTRACRANIAL ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WITH 7MM DIAMETER.  IT WAS REPORTED THAT AFTER THE CATHETER WAS POSITIONED BY THE OPERATOR, THE PED-400-20 STENT WAS DELIVERED TO THE POSITION AND DEPLOYED SMOOTHLY. WHEN RETRIEVING THE STENT PUSH ROD, THE DISTAL END OF THE PUSH ROD COULD NOT BE WITHDRAWN INTO THE CATHETER AT THE DISTAL AREA DESPITE MULTIPLE ATTEMPTS, LEAVING THE TIP/DISTAL RADIOPAQUE MARKER AND PROTECTIVE SLEEVE OUTSIDE THE CATHETER. AT THIS POINT, THE OPERATOR COULD ONLY REMOVE THE CATHETER AND THE PUSH ROD TOGETHER. THE OPERATOR STATED THAT THE STENT PUSH ROD MUST BE ABLE TO BE WITHDRAWN INTO THE CATHETER FOR REMOVAL TO ENSURE THE SAFETY AND SUCCESS OF THE PROCEDURE. THE OPERATOR REQUESTED TO FILE A COMPLAINT REGARDING THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054083 ↗
• MalfunctionJan 12, 2026Retraction Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO OBSERVED DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037263 ↗
• MalfunctionDec 30, 2025Burst Container or Vessel; Physical Resistance/Sticking; Burst Container or Vessel; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE RESISTANCE OCCURRED IN THE MIDSECTION OF THE CATHETER. THERE WAS CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AD INDICATED IN THE IFU. THERE WAS NO OBSERVED DAMAGE TO THE PIPELINE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922301 ↗
• MalfunctionDec 29, 2025Retraction Problem; Retraction Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS DAMAGE TO THE PIPELINE PUSHWIRE OR MARKSMAN CATHETER OBSERVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909414 ↗
• MalfunctionDec 18, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE MARKSMAN CATHETER WAS INITIALLY USED TO DEPLOY THE STENT, BUT RESISTANCE WAS ENCOUNTERED AT THE DISTAL SECTION OF THE CATHETER. THE MARKSMAN CATHETER WAS THEN REPLACED WITH A PHENOM 27 MICROCATHETER (MODEL: FG15150-0615-1S, LOT NUMBER: 230755171). THE CAUSE OF THE STENT OVERLAP AND THE RESISTANCE WAS NOT DETERMINED. FRICTION OR DIFFICULTY WAS NOTED DURING DELIVERY OR POSITIONING. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839843 ↗
• MalfunctionNov 26, 2025Retraction Problem; Device Damaged by Another Device; Physical Resistance/Sticking; Retraction Problem; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE PIPELINE WAS SUCCESSFULLY DEPLOYED, AND THERE WAS NO COMPLAINT REGARDING THE STENT ITSELF. HOWEVER, AFTER STENT DEPLOYMENT, THE PUSHROD COULD NOT BE RETRIEVED INTO THE MARKSMAN, WHICH INCREASED THE DIFFICULTY OF THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663098 ↗
• MalfunctionNov 21, 2025Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE SHIELD THAT FAILED TO OPEN AT THE DISTAL END AND APPEARED DAMAGED, THEN HAD RESISTANCE IN THE MARKSMAN MICROCATHETER WITH RESHEATHING AND REDEPLOYING. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF A LEFT OPHTHALMIC ARTERY UNRUPTURED AMORPHOUS ANEURYSM VIA FEMORAL ARTERY ACCESS. THE ANEURYSM MAX DIAMETER WAS 5.4MM AND THE NECK DIAMETER WAS 4.3MM. THE DISTAL LANDING ZONE WAS 3.8MM; THE PROXIMAL LANDING ZONE WAS 5.1MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). AFTER POSITIONING, DEPLOYMENT OF THE STENT WAS INITIATED. DURING DEPLOYMENT, THE STENT TIP APPEARED ROUGH AND COULD NOT BE FULLY OPENED. EVEN AFTER DEPLOYING 15MM OF THE STENT, IT STILL COULD NOT BE OPENED. LESS THAN 50% OF THE STENT WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE OPERATOR ATTEMPTED TO RETRIEVE AND REDEPLOY THE STENT, BUT FOUND THAT THE STENT COULD NEITHER BE RETRIEVED NOR REDEPLOYED AND WAS STUCK AT THE DISTAL END THE CATHETER. THE PIPELINE WAS RESHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622252 ↗
• MalfunctionNov 13, 2025Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE STENT GETTING STUCK WAS NOT DETERMINED. RESISTANCE OCCURRED IN THE MIDSECTION OF THE MICROCATHETER, AT THE RUPTURE SITE. THERE WAS NO DAMAGE TO THE STENT PUSHWIRE OBSERVED. THIS EVENT DID NOT REQUIRE A MEDICAL INTERVENTION. THERE ARE NO IMAGES OF THE RUPTURED CATHETER. NO OTHER PROBLEMS HAVE OCCURRED DURING THE RECOVERY OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544294 ↗
• MalfunctionNov 12, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT BECAUSE THE CASE WAS REPORTED AT SHORT NOTICE, THE DISTRIBUTOR¿S STAFF ASSISTED IN THE OPERATING ROOM DURING THE PROCEDURE. THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS WITHIN THE NORMAL RANGE, AROUND 150. IT WAS CLARIFIED THAT THE REPORT THAT THE RADIOPAQUE GUIDEWIRE APPEARED TO BE SEVERELY COMPRESSED WAS REFERRING TO THE PED PUSHWIRE. IT WAS CLARIFIED THAT THE PED PUSHWIRE WAS ATTEMPTED TO BE RETRIEVED USING THE DELIVERY SHEATH. THE REPORTED RESISTANCE WAS WITH THE SHEATH, AND IT WAS LATER SUSPECTED THAT THE STENT MAY HAVE BEEN STUCK BY THE SMALL WINGS. AFTER THE ENTIRE PED DEVICE AND DELIVERY SYSTEM WERE WITHDRAWN AS A WHOLE, MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE STENT BODY OUTSIDE THE BODY. IT WAS LATER SUSPECTED THAT THE STENT MAY HAVE BEEN STUCK BY THE SMALL WINGS. IT WAS SUSPECTED THAT THE COMPRESSION WAS CAUSED BY THE STENT BEING UNABLE TO BE DEPLOYED. THE CAUSE OF THE RESISTANCE DURING RESHEATHING WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533878 ↗
• MalfunctionNov 11, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. RESISTANCE OCCURRED IN THE TIP END. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. MULTIPLE PIPELINE DEVICES WERE NOT BEING USED WHEN MOVEMENT OCCURRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER WAS NOT MOVED DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522758 ↗
• MalfunctionNov 7, 2025Retraction Problem; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Retraction Problem; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS RESISTANCE, PREVENTING BOTH PUSHING AND RETRIEVAL. THE RESISTANCE WAS AT THE DISTAL END OF THE CATHETER. THERE WAS NO DAMAGE TO THE PIPELINE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498594 ↗
• MalfunctionNov 3, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PREVIOUSLY RECEIVED INFORMATION INDICATING "TUBE DAMAGE" WAS REFERRING TO POSSIBLE CATHETER DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23454445 ↗
• MalfunctionNov 3, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN AND THE RESISTANCE WAS NOT DETERMINED. THE PROXIMAL SECTION OF THE PIPELINE DID NOT OPEN, AND THE DEVICE HAD NOT BEEN PLACED IN A VESSEL BEND AT THE TIME OF FAILURE. RESHEATHING WAS ATTEMPTED TO OPEN THE PIPELINE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. DAMAGE WAS OBSERVED TO THE CATHETER, BUT AFTER REPLACING IT WITH A P27 CATHETER, NO FURTHER PROBLEMS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453160 ↗
• MalfunctionNov 3, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROXIMAL VESSEL WAS TORTUOUS, CONSTRAINING THE STENT. THE RESISTANCE ENCOUNTERED DURING STENT RETRIEVAL WAS MODERATE. THE PROXIMAL SECTION OF THE PIPELINE FAILED TO OPEN. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451805 ↗