LifeStream LSMU0800837Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05391522081185), received between Jun 25, 2019 and Feb 20, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DROPPED OUT DURING THE GAP CONTRAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738578 ↗
• MalfunctionJun 22, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A BIFURCATION CALCIFIED TARGET LESION IN THE COMMON ILIAC ARTERY VIA BIDIRECTIONAL APPROACH FROM BOTH INGUINAL REGIONS, THE DEVICE WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DISLODGED UPON THE PHYSICIAN PULLED THE SHAFT OF THE DEVICE. REPORTEDLY, THE STENT WAS PLACED IN THE EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180481 ↗
• MalfunctionApr 6, 2023Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE LEFT COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THERE WAS SLIGHT RESISTANCE FELT UPON INSERTION AND THE STENT WAS FOUND DISLODGED WITHIN THE SHEATH UPON DEFLATION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689910 ↗
• InjuryMar 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT VIA BILATERAL COMMON FEMORAL ACCESS, THE LEFT SIDE STENT GRAFT ALLEGEDLY SLIPPED OFF BALLOON DURING ADVANCING TO THE LESION. IT WAS FURTHER REPORTED THAT THE CRIMPED STENT ENDED UP COMING OFF THE WIRE AND THE PATIENT NEEDED A SMALL COMMON ILIAC ARTERY CUTDOWN TO RETRIEVE UNDEPLOYED FLOATING STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16528252 ↗
• MalfunctionFeb 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY FOUND DISLODGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433957 ↗
• MalfunctionFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE COVERED STENT WAS ALLEGEDLY FOUND TO BE MISALIGNED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395195 ↗
• MalfunctionFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE COVERED STENT WAS ALLEGEDLY FOUND TO BE MISALIGNED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395131 ↗
• MalfunctionJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA A CONTRALATERAL APPROACH, THE STENT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT AND THE DELIVERY SYSTEM WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128932 ↗
• MalfunctionDec 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY FOUND CAME OFF FROM THE DELIVERY SYSTEM UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049927 ↗
• MalfunctionOct 11, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND KINKED. IT WAS FURTHER REPORTED THAT THE STENT DISLODGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580064 ↗
• MalfunctionMay 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED FORM BALLOON PREMATURELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14301709 ↗
• MalfunctionSep 19, 2019Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT THE STENT GRAFT ALLEGEDLY BECAME STUCK IN THE SHEATH WHILE ADVANCING OVER THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087182 ↗
• MalfunctionJun 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE COMMON ILIAC ARTERY VIA RIGHT COMMON FEMORAL ACCESS, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE IN TRANSIT TO THE LESION SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731574 ↗