LifeStream LSMU1351058Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 10 mm x 58 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 05391522081314), received between Feb 18, 2020 and Feb 18, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST A BALLOON EXPANDABLE COVERED STENT PLACEMENT PROCEDURE IN THE RIGHT ILIAC ARTERY OF THE AORTA VIA ACCESS THROUGH THE LEFT COMMON FEMORAL ARTERY, THE PATIENT PRESENTED WITH PAIN IN THE LEG. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE SHORTER THAN LABELED. REPORTEDLY, THE COVERED STENT REMAINS IMPLANTED AND AN ADDITIONAL PROCEDURE IS INTENDED TO BE PERFORMED TO PLACE AN ADDITIONAL COVERED STENT IN AN ATTEMPT TO RESOLVE THE PAIN AND COVER THE TREATMENT SITE. THE PATIENT IS REPORTEDLY STABLE.
Patient problems: Injury; Pain
MAUDE report 9723442 ↗
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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