LifeStream LSMU0801238Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 12 mm x 38 mm, 80 cm catheter length · Class 3 · Implant
All models of LifeStream (37)
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 05391522081321), received between Nov 7, 2023 and Oct 8, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Device Dislodged or Dislocated1
- Material Deformation1
- Migration1
- Migration or Expulsion of Device1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT WAS TRIED BALLOONED, BUT IT KEPT ALLEGEDLY MIGRATING. IT WAS ALSO REPORTED THAT THEY ALLEGEDLY TRIED TO SNAG IT BUT IT KEPT GETTING SNAGGED. REPORTEDLY, THEY GOT IT LOW AND PLACED ANOTHER STENT OVER IT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395364 ↗InjuryNov 7, 2023Device Dislodged or Dislocated; Material Deformation; Migration; Device Dislodged or Dislocated; Material Deformation; Migration
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY, THE STENT ALLEGEDLY ALREADY MIGRATED TO THE DISTAL APART AFTER REMOVING THE SHEATH AND ATTEMPTING TO INFLATE THE DEVICE. IT WAS FURTHER REPORTED THAT THE STENT ALSO DISLODGED AFTER IT HAD EXPANDED TO ONE THIRD OF ITS LENGTH. REPORTEDLY, THAT THE STENT WAS REMOVED BY OPERATION. THERE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18085874 ↗
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 BXB085902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall2 deaths8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB077902AW. L. Gore & Associates, Inc. · Iliac covered stent, arterial1 recall8 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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