Excelsior XT-17 M003C1775ST0Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613252714866), received between Mar 20, 2019 and Jun 4, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Puncture/Hole

  THE MICROCATHETER (SUBJECT DEVICE) WAS RETURNED WITH THE ATLAS STENT DEVICE AND THE VISUAL/MICROSCOPIC INSPECTION REVEALED THAT THE SDW (STENT DELIVERY WIRE) OF THE ATLAS STENT HAD PIERCED THROUGH THE LUMEN/SHAFT OF THE SUBJECT MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398247 ↗
• MalfunctionSep 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANEURYSM-ASSISTED EMBOLIZATION PROCEDURE, AFTER THE SUBJECT MICROCATHETER WAS PROPERLY POSITIONED AND THE ATLAS STENT WAS TRANSPORTED INTO THE SYSTEM, BUT IT WAS FOUND THAT THE STENT COULD NOT BE PUSHED FORWARD. SUBSEQUENTLY, WHEN THE SYSTEM WAS WITHDRAWN, IT WAS DISCOVERED THAT THE SUBJECT MICROCATHETER HAD FRACTURED INSIDE THE INTERMEDIATE CATHETER. THE MICROCATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956925 ↗
• MalfunctionMar 5, 2025Material Puncture/Hole; Material Puncture/Hole

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT SUBJECT CATHETER (SUBJECT DEVICE) SHAFT HAD A HOLE/PERFORATION. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529702 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING PCOMA POSTERIOR COMMUNICATING ARTERY ANEURYSM STENT ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN THE STENT REACHED DISTAL OF THE SUBJECT MICROCATHETER IT GOT STUCK AND COULD NOT ADVANCE ANY MORE. THE OPERATOR TRIED FOR SEVERAL TIMES AND THEN FOUND THE TIP OF THE STENT MARKER WAS EXPANDED IN THE VESSEL. HOWEVER, THE STENT WAS NOT COMING OUT FROM TIP. SO, THE OPERATOR FELT THE DISTAL OF SUBJECT MICROCATHETER MIGHT BE FRACTURED, SO HE WITHDREW THE STENT AND SUBJECT MICROCATHETER TOGETHER THROUGH MIDDLE CATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606408 ↗
• MalfunctionApr 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE SUBJECT CATHETER SHAFT HAS HOLES/PERFORATION. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676272 ↗
• MalfunctionNov 1, 2022Fracture; Peeled/Delaminated; Material Puncture/Hole; Fracture; Peeled/Delaminated; Material Puncture/Hole

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SHAFT WAS DAMAGED AND HAD A HOLE IN THE PROXIMAL SHAFT. PTFE INNER LINER AND CATHETER (SUBJECT DEVICE) FRAGMENTS WERE ALSO PRESENT WHEN THE CATHETER WAS FLUSHED. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710129 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A CLINICAL STUDY THAT POST PROCEDURE OF TREATMENT FOR A STENT THROMBOSIS INVOLVING THE CATHETER (SUBJECT DEVICE) ON (B)(6) 2017, A SMALL CLOT WAS VISIBLE DURING LAST CONTROL OF ANGIOGRAM ON THE INFERIOR BRANCH OF THE BIFURCATION. IT LASTED LESS THAN 24 HOURS AND WAS RESOLVED WITHOUT SEQUELAE. THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO OTHER CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11246185 ↗
• MalfunctionJan 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN GUIDING THE SUBJECT CATHETER TO THE MIDDLE CEREBRAL ARTERY WITH THE GUIDEWIRE USED. PHYSICIAN THEN REPLACED THE GUIDEWIRE WITH THE SAME PRODUCT AND THE PROCEDURE WAS CONTINUED. A STENT WAS THEN INSERTED INTO THE SUBJECT CATHETER AND PHYSICIAN NOTED THERE WAS RESISTANCE. PHYSICIAN FELT A STRONG RESISTANCE IN FRONT OF THE TARGET SITE WHEN ATTEMPTING TO PLACE STENT. AS PHYSICIAN PUSHED THE STENT FORWARD, THE TIP OF THE STENT WAS PROTRUDING TO THE OUTSIDE OF THE SUBJECT CATHETER IN FRONT OF THE SECOND MARKER. PHYSICIAN PROCEEDED TO REMOVE THE SUBJECT CATHETER AND STENT FROM PATIENT. BOTH DEVICES WERE REPLACED WITH THE SAME PRODUCTS AND THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED SUBJECT CATHETER REVEALED THAT THE DEVICE HAD FRACTURED DURING USE. THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND EMDR WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11220341 ↗
• MalfunctionSep 30, 2020Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING OF THE DISTAL SHAFT OF THE MICROCATHETER (SUBJECT DEVICE) WAS PEELING AWAY WHEN REMOVED FROM THE DISPENSER HOOP. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. UPDATE: THE PRODUCT INVESTIGATION CONFIRMED THAT THE HYDROPHILIC PEELING ISSUE OF THE SUBJECT CATHETER WAS NOT CONFIRMED BASED ON ANALYSIS. THERE WERE SMALL FLAKES OF COATING IDENTIFIED ON THE CATHETER PROXIMAL SHAFT WHICH MAY HAVE BEEN PERCEIVED AS COATING PEELING BY THE PHYSICIAN. IT IS HIGHLY UNLIKELY THAT THE SMALL FLAKES OF COATING MAY CONTRIBUTED TO AND/OR CAUSE ANY PATIENT INJURY; THEREFORE, THIS RECORD HAS BEEN DEEMED NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610724 ↗
• MalfunctionAug 13, 2019Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE CATHETER PTFE (POLYTETRAFLUOROETHYLENE) INNER LINING PEELING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889028 ↗
• MalfunctionMar 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE MARKER OF THE MICROCATHETER APPEARED FRACTURED UNDER FLUOROSCOPY THE PHYSICIAN REMOVED THE MARKER WITH THE MICROCATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438539 ↗