LifeStream LSMU1350958Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05391522081277), received between Jul 2, 2019 and Nov 26, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2022Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY DISLODGED AND HAD DEVICE INCOMPATIBILITY ISSUES. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED AFTER SURGERY. FURTHERMORE BLEEDING WAS NOTED IN THE SITE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15866769 ↗
• InjuryNov 18, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DISLODGED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE STENT GOT STUCK IN THE ARTERY WALL AND THE PATIENT HAD TO BE TAKEN TO THE OPERATION ROOM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823932 ↗
• MalfunctionNov 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DISLODGED FROM THE BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15812425 ↗
• MalfunctionMar 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION OF CHRONIC TOTAL OCCLUSION IN THE COMMON ILIAC ARTERY VIA RIGHT BRACHIAL APPROACH, THE STENT WAS ALLEGEDLY FOUND TO BE DISLOCATED ON THE BALLOON. IT WAS FURTHER REPORTED THAT IT 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 13887343 ↗
• InjuryOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT TREATMENT OF A THORACIC TYPE B DISSECTION IN THE CELIAC ARTERY USING THE CHIMNEY TECHNIQUE VIA BRACHIAL ARTERY, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON. REPORTEDLY, THE HEALTHCARE PROVIDER WAS ABLE TO CATCH THE STENT GRAFT BY BRINGING IT BACK INTO THE SHEATH, BUT ALLEGEDLY DISLODGED IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE SHEATH WAS REMOVED FROM THE PATIENT AND THE STENT GRAFT REMAINED IN THE BRACHIAL ARTERY. THE HEALTHCARE PROVIDER ALLEGEDLY WAS AWARE THE PRODUCT WAS BEING USED OFF LABEL. THE PATIENT'S ARTERY WAS OPENED TO REMOVE THE STENT AND THREE VEIN GRAFTS WERE REQUIRED TO REPAIR THE ARTERY.

  Patient problems: Injury

  MAUDE report 9169088 ↗
• MalfunctionJul 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE ILIAC ARTERY VIA CALCIFIED COMMON FEMORAL ACCESS, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY REPOSITIONING THE BALLOON AND IMPLANTING THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755624 ↗