LifeStream LSMU1350716Recalls & reported problems
Clearstream Technologies Limited · LifeStream™ Balloon Expandable Vascular Covered Stent, 7 mm x 16 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05391522081543), received between Apr 2, 2019 and Jul 23, 2025 — classified as 6 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
- Device-Device Incompatibility2
- Packaging Problem1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025Packaging Problem; Packaging Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING LIFESTREAM DEVICE, PRIOR TO THE PROCEDURE, THE PACKAGES RECEIVED WAS ALLEGEDLY WET FROM INSIDE AND OUTSIDE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22573406 ↗MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN EXPANDABLE STENT GRAFT PLACEMENT PROCEDURE IN THE ILIAC THROUGH COMMON FEMORAL ACCESS, THE CATHETER DELIVERY SYSTEM ALLEGEDLY DID NOT FIT INTO A 6FR INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13576912 ↗MalfunctionFeb 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VESSEL VIA ACCESS THROUGH THE GROIN, THE COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON AT THE BIFURCATION LANDMARK. THEREFORE, THE DELIVERY SYSTEM AND STENT WERE RETRACTED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9700149 ↗MalfunctionDec 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING TREATMENT OF THE CELIAC ARTERY VIA RIGHT FEMORAL ARTERY ACCESS, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON DURING DEPLOYMENT AND WAS UNINTENTIONALLY IMPLANTED IN THE SPLENIC ARTERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9404342 ↗MalfunctionOct 24, 2019Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING MESENTERY STENTING VIA LEFT BRACHIAL ACCESS, THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY FAILED TO ADVANCE THROUGH THE 6FR INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT UPON REMOVAL, THE COVERED STENT ALLEGEDLY FELL OFF THE DELIVERY SYSTEM ONTO THE TABLE. THE PROCEDURE WAS RESCHEDULED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9233550 ↗MalfunctionApr 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE FOR TREATMENT OF CTO IN THE INNOMINATE ARTERY VIA FEMORAL ACCESS, THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON PRIOR TO DEPLOYMENT. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO POST-DILATE AND APOSE THE DISLODGED STENT TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8475044 ↗
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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