Excelsior 1018 M0031441890Recalls & reported problems
Stryker Corporation · 2Tip Straight Reinforced Microcather · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540688125), received between Mar 8, 2019 and Dec 18, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Defective Component1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Unintended Radiation Exposure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING ENDOVASCULAR COILING PROCEDURE AS THE 4TH DETACHABLE COIL WAS ATTEMPTED BUT DURING DEPLOYMENT, THE MICROCATHETER¿S TIP (SUBJECT DEVICE) HERNIATED OUT OF THE ANEURYSM NECK. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE UNSUCCESSFULLY TO PASS THE PREVIOUS PLACED STENT AND ADVANCE THE SUBJECT MICROCATHETER INTO THE VENTRAL PORTION OF THE ANEURYSM DOME WHICH RESULTED IN AN EXTENDED DURATION OF PROCEDURE AND RADIATION EXPOSURE. THE COIL WAS RETRIEVED WITHOUT DETACHMENT. THE SUBJECT DEVICE WAS EXCHANGED FOR ANOTHER MICROCATHETER TO COMPLETE THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: Unintended Radiation Exposure
MAUDE report 23838584 ↗MalfunctionOct 19, 2022Defective Component; Component Missing; Defective Component; Component Missing
IT WAS REPORTED THAT WHEN THE SUBJECT MICROCATHETER WAS USED IN A PATIENT WITH ABDOMINAL AORTIC ANEURYSM, THE MARKERS COULD NOT BE SEEN UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15633226 ↗MalfunctionMar 8, 2019Peeled/Delaminated; Peeled/Delaminated
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE (POLYTETRAFLUOROETHYLENE) COATING HAD PEELED/SCRAPED OFF. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8406221 ↗
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- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.