LifeStream LSMU0800716Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 7 mm x 16 mm, 80 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391522081505), received between Nov 7, 2018 and Mar 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Device Dislodged or Dislocated
A PATIENT PREPPED FOR A STENT PLACEMENT PROCEDURE BY USING LIFESTREAM. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE HCP TOOK OFF THE COVER OF THE BALLOON, AND THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24515931 ↗MalfunctionSep 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING PREPARATION FOR A COVERED STENT DEPLOYMENT PROCEDURE, THE BALLOON EXPANDABLE COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8984016 ↗MalfunctionNov 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING POSITIONING OF THE BALLOON EXPANDABLE COVERED STENT IN THE CELIAC ARTERY, THE HEALTH CARE PROVIDER (HCP) DID NOT WANT TO DEPLOY THE COVERED STENT THROUGH THE TIGHT STENOSIS OF THE LESION WITHOUT THE PROTECTION OF THE SHEATH; THEREFORE, THE HCP RETRACTED THE PARTIALLY EXPOSED COVERED STENT BACK INTO THE INTRODUCER SHEATH AND PULLED THE BALLOON CATHETER BACK TO THE HEMOSTATIC VALVE OF THE SHEATH. AT THIS POINT, THE BALLOON CATHETER WAS COMPLETELY REMOVED AND THE HCP ALLEGEDLY IDENTIFIED THAT THE COVERED STENT WAS NO LONGER ATTACHED TO THE BALLOON CATHETER. FLUOROSCOPY WAS USED TO LOCATE THE COVERED STENT AT THE VALVE OF THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8047007 ↗
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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