LifeStream LSMU1350826Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 8 mm x 26 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
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05391522081215), received between Apr 4, 2018 and Apr 17, 2024 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 Dislocated10
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Vascular Dissection1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY CAME OFF THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19123108 ↗MalfunctionApr 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY CAME OFF THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19123107 ↗MalfunctionMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA LEFT ILIAC ARTERY, THE STENT ALLEGEDLY DEPLOYED BEFORE IT COULD BE ADVANCED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13900697 ↗MalfunctionMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA LEFT ILIAC ARTERY, THE STENT ALLEGEDLY DEPLOYED BEFORE IT COULD BE ADVANCED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13900692 ↗MalfunctionMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA LEFT ILIAC ARTERY, THE STENT ALLEGEDLY DEPLOYED BEFORE IT COULD BE ADVANCED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13900541 ↗MalfunctionMar 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE, THE STENT WAS ALLEGEDLY SLID OFF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13820528 ↗MalfunctionFeb 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DETACHED FROM THE BALLOON WHEN THE PROTECTOR WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13531027 ↗InjuryMar 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA LEFT BRACHIAL ACCESS THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM. FURTHERMORE, A SNARE WAS USED TO RETRIEVE THE DEVICE AND THE SUBCLAVIAN ARTERY WAS DISSECTED. REPORTEDLY, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Vascular Dissection
MAUDE report 8461921 ↗MalfunctionMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT UPON REMOVING THE STENT GUARD, THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8418578 ↗MalfunctionApr 4, 2018Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A AAA PROCEDURE, THE CATHETER WAS ALLEGEDLY DIFFICULT TO LOAD INTO THE SHEATH. THE CATHETER AND SHEATH WERE REMOVED AND THE SHEATH WAS RE-POSITIONED. ANOTHER ATTEMPT WAS MADE TO INSERT THE CATHETER THROUGH THE SHEATH WHICH WAS SUCCESSFUL; HOWEVER, THE STENT DISLODGED FROM THE BALLOON CATHETER. THE CATHETER AND SHEATH WERE REMOVED FROM THE PATIENT AND A SNARE WAS USED TO RETRIEVE THE DISLODGED STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7396773 ↗
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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