EXCELSIOR XT-27 M003XT2750910Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540698155), received between Apr 8, 2019 and Sep 25, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fracture

  It was reported that the microcatheter (Subject device) was used in the treatment of opthalmic artery aneurysm procedure. After the stent was advanced to the midsection of the subject microcatheter, resistance was encountered. The physician then increased the pushing force resulting in fracture to the hub of the subject device. The subject device was then withdrawn and replaced, and the procedure was reported to be completed successfully without any clinical consequence to the patient. However, when the subject device was returned for analysis the shaft of the subject device was observed to be kinked/bent, flat/crushed and had friction at the damaged sections. Also, the shaft of the subject device was noted to be broken/fractured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892962 ↗
• MalfunctionApr 7, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT ANEURYSM, THAT WHEN DEPLOYING A STENT IN PLACE AND PUSHING IT OUT BY APPROXIMATELY TWO-THIRDS, THE PHYSICIAN ENCOUNTERED ABNORMAL RESISTANCE WITHIN THE SUBJECT MICROCATHETER. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. 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 24801582 ↗
• MalfunctionMar 6, 2026Fracture

  ANALYSIS OF THE RETURNED MICROCATHETER DEVICE WAS FOUND THAT THE SHAFT OF THE SUBJECT MICROCATHETER DEVICE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537159 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE OF THE STENT IMPLANTATION WAS CONDUCTED ON (B)(6) 2025 AS THE PATIENT HAD NO LIMB HEMIPLEGIA OR APHASIA AND CRANIAL AFTER SURGERY. AFTER THE PROCEDURE, THE DIAGNOSTIC IMAGING AND MRI (MAGNETIC RESONANCE IMAGING) SHOWED TWO ACUTE LACUNAR INFARCTION FOCI IN THE LEFT SUBCORTEX SENILE CEREBRAL CHANGES LEFT MAXILLARY SINUSITIS: MILD RIGHT MASTOID INFLAMMATION POSTOPERATIVE CHANGES OF THE LEFT OCULAR LENS. THE EVENT WAS CONSIDERED AS AN ISCHEMIC STROKE LOCATED AT IPSILATERAL AND IT WAS TREATED WITH MEDICATION. ONE DAY POST PROCEDURE ON (B)(6) 2025, THE PATIENT DEVELOPED BINOCULAR DIPLOPIA AS IT WAS RESOLVED ON (B)(6) 2025. THE PATIENT RECEIVED INTRAVENOUS INFUSION OF HUMAN ALBUMIN FOR VOLUME EXPANSION. LATER, A NEW LACUNAR CEREBRAL INFARCTION WAS DETECTED BY MRI, AND EDARAVONE DEXBORNEOL WAS ADMINISTERED TO SCAVENGE FREE RADICALS. IN PHYSICIAN¿S OPINION, THE CAUSE OF THE STROKE AND BINOCULAR DIPLOPIA AS THE STENT IMPLANTATION COVERS THE OPHTHALMIC ARTERY, CAUSING A THROMBOGENIC REACTION THAT AFFECTS THE BLOOD SUPPLY OF THE CENTRAL RETINAL ARTERY AND PROBABLY ALSO RELATED TO THE CATHETER (SUBJECT DEVICE). CURRENTLY, THERE IS NO IMPAIRMENT IN DAIL

  Patient problems: Ischemia Stroke; Visual Disturbances

  MAUDE report 24060000 ↗
• MalfunctionJun 24, 2025Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DIRECTLY BELOW THE HUB. 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 22325009 ↗
• MalfunctionFeb 24, 2025Fracture; Fracture

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE CATHETER SHAFT (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. 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 21447178 ↗
• MalfunctionJun 20, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MICROCATHETER (SUBJECT DEVICE) SHAFT WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578283 ↗
• MalfunctionAug 17, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATOR PLACED THE SUBJECT MICROCATHETER TO DEPLOY THE STENT. WHEN WITHDRAWING THE SUBJECT MICROCATHETER TO DEPLOY THE STENT, THE OPERATOR FELT FRICTION, HE TRIED SEVERAL TIMES TO ADJUST BY ADVANCING THE STENT SYSTEM AND SUBJECT MICROCATHETER BUT BIG FRICTION WAS STILL ENCOUNTERED. FINALLY, THE OPERATOR WITHDREW THE STENT AND SUBJECT MICROCATHETER OUT TOGETHER AND FOUND PART OF THE STENT PROTRUDED THROUGH THE SUBJECT MICROCATHETER SHAFT. 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 17565301 ↗
• MalfunctionMar 21, 2023Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 16585039 ↗
• MalfunctionFeb 24, 2023Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE INNER LINING OF SUBJECT MICROCATHETER WAS PEELED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440536 ↗
• MalfunctionFeb 2, 2023Fracture; Fracture

  THE MICROCATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. 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 16287425 ↗
• MalfunctionDec 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION REVEALED THAT THE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS PEELING. THERE WAS NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072452 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT SUBJECT CATHETER TIP WAS BROKEN/FRACTURED DURING USE AND RADIO OPAQUE (RO) MARKERS(S) DETACHED/SEPARATED/NOT VISIBLE UNDER FLUOROSCOPY. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418967 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHENOM 27 DEVICE COULD NOT BE PLACED IN THE LANDING ZONE AND IT WAS EXCHANGED FOR AN SUBJECT EXCELSIOR MICROCATHETER FOR BETTER ACCESS. THE PIPELINE WAS STACKED INSIDE AND IT WAS NOT ABLE TO RELEASE THE PIPELINE IN THE LANDING ZONE. THE PIPELINE WAS STUCK DURING DELIVERY BEFORE THE DISTAL COIL EXITED THE SUBJECT MICROCATHETER. MANY ATTEMPTS WERE MADE TO PUSH AND PULL THE PIPELINE AND TO REPOSITION THE SUBJECT MICROCATHETER, BUT WITHOUT SUCCESS. THE SUBJECT MICROCATHETER DEVICE WAS REPLACED BY ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE. POST PROCEDURAL ANGIOGRAPHY SHOWED COMPLETE OCCLUSION. NO PATIENT INJURY WAS REPORTED AS A RESULTS OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR UNRUPTURED FUSIFORM ANEURYSM MEASURING 25MMX15MM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA)/C7. THE DISTAL AND PROXIMAL LANDING ZONE WAS 3.00MMX4,50MM. THE VASCULATE WAS SEVERE IN TORTUOSITY. THE PATIENT WAS ON DUAL ANTIPLATELET. THE SUBJECT MICROCATHETER WAS FLUSHED WITH HEPARINIZED SALINE. PHYSICIAN RELEASED LOAD BUT DID NOT SOLVE PROBLEM. NO DAMAGE NOTED ON THE SUBJECT CATHETER OR THE PUSHWIRE. NO OTHER INFORMATION W

  Patient problems: Obstruction/Occlusion

  MAUDE report 15031172 ↗
• MalfunctionDec 22, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A NEUROVASCULAR SURGICAL PROCEDURE WAS PERFORMED ON A PATIENT WITH NINETY PERCENT STENOSIS IN RIGHT MCA (MIDDLE CAROTID ARTERY). INITIALLY A GUIDEWIRE WAS DELIVERED TO PASS THE TARGET LESION AND THEN THE TARGET LESION WAS DILATED USING A BALLOON. LATER THE SUBJECT MICROCATHETER WAS ADVANCED ALONG WITH THE GUIDEWIRE TO REACH THE DISTAL TARGET LESION AND THEN PREPARED TO DEPLOY THE STENT. DURING DELIVERY THE STENT ENCOUNTERED RESISTANCE ADVANCING THROUGH THE SUBJECT MICROCATHETER. THE STENT WAS RETRIEVED AND TRIED AGAIN BUT RESISTANCE WAS STILL ENCOUNTERED. WHEN THE OPERATOR TRIED TO WITHDRAW THE STENT AGAIN, THIS TIME THE STENT COULD NOT BE RETRIEVED. WHEN THE OPERATOR CHECKED UNDER DSA IT WAS FOUND THAT THE STENT WAS STUCK IN SUBJECT MICROCATHETER AT THE ANATOMICAL LOCATION OF TAIL OF ICA (INTERNAL CAROTID ARTERY)AND HENCE THE STENT WAS NOT ABLE TO REACH THE TARGET LESION. WHEN CHANGED TO ANOTHER VIEW, IT WAS FOUND THAT THE TIP OF THE STENT WAS DEPLOYED. THE OPERATOR WITHDREW THE STENT ALONG WITH THE SUBJECT MICROCATHETER AND THE GUIDEWIRE OUT OF PATIENT'S BODY AND FOUND THAT THE STENT HAD PERFORATED THE TIP OF SUBJECT MICROCATHETER, HENCE THE TIP OF THE STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061523 ↗
• MalfunctionJun 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE BEING PLACED AND ADJUSTED, THE CATHETER (SUBJECT DEVICE) TAIL WAS FRACTURED. THE PHYSICIAN REPLACED THE SUBJECT DEVICE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971438 ↗
• MalfunctionApr 8, 2019Break; Break

  DURING DEVICE INVESTIGATION, THE CATHETER SHAFT WAS FOUND BROKEN. NO CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491889 ↗