LifeStream LSMU1351238Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 12 mm x 38 mm, 135 cm catheter length · Class 3 · Implant
All models of LifeStream (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391522081345), received between Jul 23, 2025 and Jul 23, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL (ARCH (BDPI-20-004) OF A NON-COMMERCIALLY AVAILABLE DEVICE (BD LIVERTY TIPS STENT GRAFT), THAT SOMETIME LATER POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF OCCLUSION OF THE TIPS STENT GRAFT. IT WAS FURTHER REPORTED THAT SUBJECT WAS IMPLANTED WITH COMMERCIALLY AVAILABLE LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT. APPROXIMATELY FOUR DAYS POST LIFESTREAM STENT IMPLANTATION PROCEDURE, THE SUBJECT BEGAN FALLING ILL AND UNDERWENT COMPUTED TOMOGRAPHY WHICH SHOWED OCCLUSION OF THE LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT. THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND STUDY PROCEDURE. THE SUBJECT UNDERWENT REVISION AND THE EVENT WAS RESOLVED.
Patient problems: Obstruction/Occlusion
MAUDE report 22575319 ↗
Other Iliac covered stent, arterial devices
- GORE VIABAHN VBX Balloon Expandable Endo BXB073902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths19 reports
- iCast Covered Stent System, 6mmX16mmX120cm 42616Atrium Medical Corporation · Iliac Covered Stent, Arterial1 recall15 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB057902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB067902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB075902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB095902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB077902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB085902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths8 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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