LifeStream LSMU1350737Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05391522081147), received between May 10, 2018 and May 8, 2026 — classified as 1 injury, 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Device Dislodged or Dislocated

  A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT CAME NOT MOUNTED ON THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124244 ↗
• MalfunctionOct 1, 2024Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE OUTER PROTECTIVE COVER ALLEGEDLY COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY PULLED OFF THE BALLOON AND STAYED INSIDE THE OUTER PROTECTIVE COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342765 ↗
• InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE ADVANCING THROUGH THE LESION AND IT WAS ALLEGEDLY STUCK IN THE AORTA. REPORTEDLY, THE STENT WAS ALLEGEDLY UNABLE TO SNARE OUT AND THEREFORE, IT WAS DEPLOYED IN THE AORTA. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19021774 ↗
• MalfunctionMar 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE BALLOON WAS ALLEGEDLY NOTED TO BE RUPTURED AFTER THE REMOVAL OF DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938543 ↗
• MalfunctionFeb 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF OF THE BALLOON OUTSIDE OF THE PATIENTS BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13616899 ↗
• MalfunctionSep 23, 2020Device Dislodged or Dislocated; Packaging Problem; Device Dislodged or Dislocated; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, WHILE FLUSHING, THEY ATTEMPTED TO TAKE THE GUARD AND THE STENT ALLEGEDLY CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10571911 ↗
• MalfunctionJan 31, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE RIGHT COMMON AND EXTERNAL ILIAC ARTERY VIA POPLITEAL ARTERY APPROACH, THE DELIVERY SYSTEM ALLEGEDLY FAILED TO CROSS THE LESION. AS A RESULT, THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO REMOVE THE DELIVERY SYSTEM AND THE STENT DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE STENT WAS RETRIEVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9653619 ↗
• MalfunctionJan 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE REMOVING THE GUARD DURING PREPARATION, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9588850 ↗
• MalfunctionApr 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY WAS DISLODGED FROM THE BALLOON AS THE STENT GUARD WAS REMOVED. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8489433 ↗
• MalfunctionMar 7, 2019Device Dislodged or Dislocated; Packaging Problem; Device Dislodged or Dislocated; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A STENT GRAFT PLACEMENT PROCEDURE THE STENT GUARD WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE STENT GRAFT CAUSING THE STENT GRAFT TO ALLEGEDLY DISLODGE FROM THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8401982 ↗
• MalfunctionMay 10, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT IN AN ILIAC LESION VIA A CONTRALATERAL RETROGRADE APPROACH THROUGH A FEMORAL ACCESS, THE BALLOON EXPANDABLE VASCULAR COVERED STENT CATHETER ALLEGEDLY FAILED TO LOAD THROUGH A 6FR INTRODUCER SHEATH AS IT WAS BEING ADVANCE INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) FELT ALLEGED RESISTANCE WITH THE STENT GRAFT CATHETER AND RATHER THAN CONTINUE ADVANCING IT TO THE TARGET LESION, THE HCP DECIDED TO BACK OUT THE ENTIRE STENT GRAFT AND CATHETER THROUGH THE INTRODUCER SHEATH. UNFORTUNATELY, WHEN DOING SO THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER WITHIN THE INTRODUCER SHEATH. REPORTEDLY, THE DISLODGED STENT GRAFT AND THE INTRODUCER SHEATH WERE REMOVED AS ONE UNIT, EXCHANGED, AND REPLACED WITH ANOTHER 6X45 INTRODUCER SHEATH, AND A NEW 6X37MM BALLOON EXPANDABLE COVERED STENT CATHETER IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503813 ↗