LifeStream LSMU1350816Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391522081628), received between May 24, 2018 and Sep 4, 2019 — classified as 2 injuries, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2019Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE SLIGHTLY CALCIFIC RIGHT RENAL ARTERY VIA RIGHT GROIN ACCESS, THE HEALTHCARE PROVIDER (HCP), AWARE OF THE OFF-LABEL INDICATION FOR USE, ADVANCED THE DELIVERY SYSTEM TO THE LESION AND INFLATED THE BALLOON TO 8 ATM, AND THEN REALIZED THE INTRODUCER SHEATH MAY HAVE BEEN COVERING THE PROXIMAL END OF THE STENT GRAFT. THEREFORE, THE BALLOON WAS DEFLATED AND UPON RETRACTING THE DELIVERY SYSTEM, THE DEVICE ALLEGEDLY CAUGHT ON THE STENT GRAFT AND PULLED IT BACK INTO THE INTRODUCER SHEATH CAUSING IT TO ALLEGEDLY DISLODGE 30CM. IT WAS FURTHER REPORTED THAT THE HCP USED ANOTHER MANUFACTURER'S PTA CATHETER AND INFLATED IT INSIDE THE STENT GRAFT, SUCCESSFULLY REMOVED IT THOUGHT THE INTRODUCER SHEATH. REPORTEDLY, ANOTHER DELIVERY SYSTEMS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960660 ↗
• InjuryJul 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER WHEN THE BALLOON WAS INFLATED TO 4 ATM, BUT REMAINED ON THE CATHETER. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) WAS ABLE TO POSITION THE BALLOON CATHETER WITHIN THE COVERED STENT AND INFLATED THE BALLOON TO 8 ATM AND THE STENT ALLEGEDLY DISLODGED AND DETACHED FROM THE BALLOON CATHETER. REPORTEDLY, THE HCP REMOVED AND REPLACED THE BALLOON CATHETER WITH A 60 MM BALLOON CATHETER AND WAS ABLE TO FULLY EXPAND THE COVERED STENT IN THE COMMON ILIAC. REPORTEDLY, ANOTHER BALLOON EXPANDABLE COVERED STENT WAS USED TO TREAT THE LESION IN THE INTERNAL ILIAC. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7686631 ↗
• InjuryMay 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT OF THE RIGHT COMMON ILIAC ARTERY WITH ACCESS GAINED THROUGH THE LEFT FEMORAL ARTERY, THE STENT ALLEGEDLY CAUGHT ON THE END OF THE SHEATH AS THE SHEATH WAS PULLED BACK AND DISLODGED OFF THE BALLOON. NO RESISTANCE WAS FELT WHEN ADVANCING THE DEVICE THROUGH THE SHEATH. BOTH THE SHEATH AND STENT SYSTEM WERE REMOVED AS ONE UNIT; HOWEVER, THE STENT ALLEGEDLY CAME OFF OF THE SHEATH IN THE LEFT FEMORAL ARTERY. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE STENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS ASYMPTOMATIC.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7542362 ↗