LifeStream LSMU1350658Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 6 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391522081079), received between Aug 30, 2022 and Mar 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM. DURING A PROCEDURE, AFTER THE DEVICE WAS INSERTED INTO THE SHEATH, THE BALLOON BECAME LODGED AND COULD NOT ADVANCE PROPERLY. UPON REMOVAL, THE BALLOON CATHETER DETACHED AND EXITED THE SHEATH HOWEVER, THE STENT PORTION REMAINED LODGED INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555170 ↗MalfunctionAug 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY FELL OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15318324 ↗
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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