LifeStream LSMU0800616Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 6 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05391522081420), received between Aug 23, 2017 and Apr 16, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Failure to Advance2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. DURING THE PROCEDURE, THE STENT FELL OFF IN THE SHEATH. REPORTEDLY, IT WAS REMOVED FROM THE BODY BY REMOVING THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893091 ↗MalfunctionMay 17, 2022Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE SHAFT WAS NOTED TO BE KINKED UPON REMOVAL FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14424150 ↗MalfunctionOct 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT, THE STENT ALLEGEDLY DISLODGED OFF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704337 ↗MalfunctionOct 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE THROUGH THE RIGHT FEMORAL, THE STENT WAS ALLEGEDLY NOT TIGHTLY MOUNTED ONTO THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12629618 ↗MalfunctionAug 23, 2017Failure to Advance
IT WAS REPORTED THAT THE DEVICE COULD NOT BE ADVANCED THROUGH THE SHEATH. WHILE IN PREPARATION FOR A STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT ADVANCE THROUGH THE SHEATH. REPORTEDLY, A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6813721 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page