LifeStream LSMU0800858Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05391522081192), received between Sep 22, 2017 and Jun 16, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Device-Device Incompatibility

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL WAS UNABLE TO PROPERLY INSERT THE DEVICE INTO THE SHEATH. CONSEQUENTLY, THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514484 ↗
• MalfunctionApr 18, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM. IT WAS REPORTED THAT DURING PROCEDURE, THE STENT DISLODGED FROM THE BALLOON ON WHICH IT WAS MOUNTED BEFORE REACHING THE LESION. THE DISLODGED STENT HAS BEEN RETRIEVED FROM THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919228 ↗
• MalfunctionOct 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE ILIAC ARTERY, THE STENT ALLEGEDLY DISLODGED. REPORTEDLY THE STENT WAS RETRIEVED AND NOT REUSED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428028 ↗
• MalfunctionSep 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED AND SOAKED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141882 ↗
• MalfunctionSep 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED AND SOAKED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141881 ↗
• MalfunctionSep 2, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN LEFT COMMON ILIAC ARTERY VIA LEFT FEMORAL ARTERY, THE STENT GRAFT ALLEGEDLY CAME OFF THE BALLOON. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD RESISTANCE WHILE TRACKING IN COMMON ILIAC ARTERY THE STENT GRAFT WAS ALLEGEDLY REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116539 ↗
• MalfunctionJul 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THE LOOSENING OF THE BALLOON MOUNT WAS ALLEGEDLY CONFIRMED, AND USE WAS DISCONTINUED DUE TO CONCERNS THAT IT MIGHT FALL OFF DURING DELIVERY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791779 ↗
• MalfunctionJan 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT COMMON ILIAC ARTERY, THE STENT GRAFT ALLEGEDLY SLIGHTLY DISPLACED AT THE ENTRANCE OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524149 ↗
• MalfunctionNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY GOT CAUGHT IN THE SHEATH AND FELL OUT DURING INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128646 ↗
• MalfunctionJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM UPON REMOVING THE STENT COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314735 ↗
• MalfunctionFeb 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA AN IPSILATERAL RETROGRADE APPROACH, THE STENT ALLEGEDLY MISALIGNED FROM THE BALLOON AT THE INSERTION SITE OF THE SHEATH. 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 16450882 ↗
• MalfunctionOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THE COVER STENT GOT STUCK WITH THE TIP OF THE SHEATH AND WAS MISALIGNED WHEN THE PHYSICIAN RETRACED THE COVER STENT TO DEPLOY AT CORRECT POSITION. IT WAS FURTHER REPORTED THAT THE MISALIGNED COVER STENT WAS LEFT DEPLOYED AT THE POSITION AND ANOTHER DEVICE WAS USED AS ADDITIONAL TO COVER THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665360 ↗
• MalfunctionMar 29, 2022Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE BILATERAL COMMON ILIAC ARTERY VIA A BILATERAL FEMORAL APPROACH, THE DEVICE WAS ALLEGEDLY UNABLE TO REACH THE LESION. THE STENT WAS REPORTED TO BE STUCK WITH THE TIP OF THE SHEATH UPON ATTEMPTING TO EXCHANGE THE GUIDEWIRE, WHICH LED TO A STENT DISLODGEMENT FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13936176 ↗
• MalfunctionSep 22, 2017Detachment Of Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED. THE DEVICE WAS TO BE USED TO REPAIR AN ANEURYSM. THE DEVICE WAS BEING ADVANCED INTO A STEEP BEND IN THE ANATOMY AND THE STENT ALLEGEDLY CAME OFF OF THE BALLOON. THERE WAS ALSO ANOTHER LIFESTREAM DEVICE USED IN THIS PROCEDURE WHERE THE STENT ALSO DISLODGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6885750 ↗