Excelsior 1018 M0031441900Recalls & reported problems
Stryker Corporation · 2 Tip Pre-Shaped 45 Microcather · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540688132), received between Mar 7, 2024 and May 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
Patient problems
- Embolism/Embolus1
- Ischemia Stroke1
- Movement Disorder1
- No Clinical Signs, Symptoms or Conditions1
- Speech Disorder1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WITHIN 48 HOURS AFTER PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE MICRO EMBOLIC INFARCTIONS ON THE RIGHT, FEW ON THE LEFT SIDE RESULTING IN WORD FINDING DISORDER AND FINE MOTOR DISORDER LEFT HAND. THE OUTCOME WAS RESOLVED, WITHOUT SEQUELAE.
Patient problems: Embolism/Embolus; Ischemia Stroke; Movement Disorder; Speech Disorder
MAUDE report 22074544 ↗MalfunctionMar 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE SALINE SOLUTION LEAKED FROM THE STRAIN RELIEF AREA OF THE SUBJECT MICROCATHETER. AFTER THAT, SUBJECT MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER AND COMPLETED THE PROCEDURE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857250 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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