LifeStream LSMU0800758Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05391522081116), received between Sep 22, 2017 and May 7, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT USING A STENT GRAFT PLACEMENT PROCEDURE USING LIFESTREAM STENT GRAFT TO TREAT LEFT BRACHIAL ACCESS AND LEFT COMMON FEMORAL ACCESS, ATTEMPTING REVASCULARIZATION OF A LEFT ILIAC ARTERY CHRONIC TOTAL OCCLUSION. A LIFESTREAM STENT WAS PREPPED AND DELIVERED TO THE SITE AND DEPLOYED WITHOUT COMPLICATION. ADDITIONAL ANGIOGRAPHY WAS PERFORMED AND SHOWED CONTINUED EXTRAVASATION AT THE MID STENT SITE. ANOTHER COVERED STENT WAS INSERTED AND DEPLOYED COVERING THE FULL LENGTH OF THE LIFESTREAM 7X58. FINAL ANGIOGRAPHY REVEALED CLOSURE OF THE PERFORATION. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 21974461 ↗
• MalfunctionNov 19, 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 DURING THE PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE IN THE OCCLUDED COMMON ILIAC ARTERY VIA THE COMMON FEMORAL ARTERY APPROACH, THERE WAS ALLEGEDLY A DIFFICULTY IN REMOVING THE PROTECTOR FROM THE STENT. IT WAS FURTHER REPORTED THAT THE WHEN THE PROTECTOR WAS REMOVED WITH FORCE, THE PROXIMAL PART OF THE STENT HAD ALLEGEDLY BECAME LOOSENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730124 ↗
• MalfunctionOct 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR CHRONIC TOTAL OCCLUSION LESION VIA IPSILATERAL APPROACH, THE LESION COULD NOT BE COVERED AND THE STENT GRAFT ALLEGEDLY DROPPED DURING LESION RETRACTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479270 ↗
• MalfunctionFeb 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY GOT DISLODGED FROM THE BALLOON. REPORTEDLY, A SNARE HAD TO BE UTILIZED TO RETRIEVE THE STENT GRAFT THAT HAD DETACHED FROM THE BALLOON MOUNT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738830 ↗
• MalfunctionDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED WITHIN THE SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316668 ↗
• MalfunctionJan 31, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN ALLEGEDLY FELT RESISTANCE WHEN ADVANCING THE STENT TO THE LESION SITE. IT WAS FURTHER REPORTED THAT THE STENT WAS FOUND TO BE MISALIGNED FROM THE BALLOON AND WHEN THE PHYSICIAN TRIED TO PULL THE COVERED STENT BACK INSIDE THE SHEATH, THE DEVICE WAS UNABLE TO BE REMOVED AND GOT STUCK WITH THE SHEATH. THE DEVICE WAS FURTHER REPORTED TO HAVE MIGRATED OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED OFF THE PATIENT AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391418 ↗
• MalfunctionNov 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE EXTERNAL ILIAC ARTERY, THE COVERED STENT WAS MISALIGNED FROM THE BALLOON. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT. 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 12841910 ↗
• MalfunctionSep 22, 2017Device 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 6885732 ↗