LifeStream LSMU1350758Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 7 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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05391522081154), received between Aug 15, 2018 and May 20, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Dislocated6
- Retraction Problem2
- Device-Device Incompatibility1
- Leak/Splash1
- Migration or Expulsion of Device1
Patient problems
- Blood Loss2
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Stenosis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Migration or Expulsion of Device; Device Dislodged or Dislocated
A PATIENT UNDERWENT A BALLOON EXPANDABLE STENT GRAFT PROCEDURE USING THE LIFESTREAM DEVICE. DURING THE PROCEDURE, THE SHEATH AND STENT BEGAN TO MIGRATE OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225962 ↗MalfunctionFeb 2, 2026Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT FOR A STENT PLACEMENT PROCEDURE USING LIFESTREAM. PRIOR TO THE PROCEDURE, DURING INSTALLATION, THE LIFESTREAM COVERED STENT CAME OFF THE STENT BALLOON INSIDE THE SHEATH. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232135 ↗InjuryJun 18, 2020Leak/Splash; Retraction Problem; Device Dislodged or Dislocated; Leak/Splash; Retraction Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM DURING TREATMENT OF VERY CALCIFIED, BILATERAL ILIAC ARTERIES WITH 95% STENOSIS, AND WAS UNABLE TO BE RETRIEVED. IT WAS FURTHER REPORTED THAT ANOTHER STENT GRAFT WAS USED TO OPPOSE THE DISLODGED STENT AGAINST THE ARTERY VESSEL WALL. REPORTEDLY, THE PATIENT THEN HAD ALLEGED BLEEDING AND THE AREA WAS COVERED WITH AN ADDITIONAL COVERED STENT. PATIENT CURRENT STATUS WAS NOT PROVIDED.
Patient problems: Blood Loss
MAUDE report 10166391 ↗InjuryJun 16, 2020Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE STENT WAS PRESENT IN THE RIGHT EXTERNAL ILIAC ARTERY, THE DEVICE ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE STENT COULD NOT BE RETRIEVED AND THE PATIENT FOUND TO BE BLEEDING. THE PATIENT STATUS IS UNKNOWN.
Patient problems: Blood Loss; Stenosis
MAUDE report 10157202 ↗MalfunctionFeb 14, 2019Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE BALLOON EXPANDABLE VASCULAR COVERED STENT WAS ALLEGEDLY DIFFICULT TO LOAD ONTO THE GUIDEWIRE. AFTER THE DELIVERY SYSTEM WAS PULLED OFF THE GUIDEWIRE, IT WAS IDENTIFIED THAT THE BALLOON EXPANDABLE VASCULAR COVERED STENT WAS ALLEGEDLY LOOSE ON THE DELIVERY SYSTEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8339620 ↗MalfunctionAug 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE BALLOON EXPANDABLE VASCULAR COVERED STENT IN THE ILIAC ARTERY, THE STENT WAS ALLEGEDLY DISLODGED AND NOT IMPLANTED IN DESIRED LOCATION. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7787301 ↗
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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