LifeStream LSMU0800637Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05391522081024), received between May 24, 2018 and Feb 6, 2026 — classified as 1 death, 14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Device Dislodged or Dislocated

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM STENT. IT WAS REPORTED THAT DURING STENT PREPARATION, WHEN THE HEALTHCARE PROFESSIONAL ATTEMPTED TO REMOVE THE PROTECTIVE COVER, THE STENT DETACHED FROM THE BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277313 ↗
• DeathJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF THE RIGHT ILIAC THROUGH RETROGRADE PASSAGE, A BARE STENT WAS PLACED WITHIN ANOTHER MANUFACTURERS STENT AND AN EXPANDABLE STENT GRAFT WAS ALSO PLACED PROXIMATELY AND POST DILATED WITH ANOTHER MANUFACTURERS BALLOON CATHETER. IT WAS FURTHER REPORTED THAT A FINAL ANGIOGRAPH SHOWED ALLEGED BLEEDING FROM THE ILIAC; THEREFORE, ANOTHER EXPANDABLE STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT ANOTHER BARE STENT WAS PLACED IN THE COMMON ILIAC ARTERY. THE PATIENT REPORTEDLY EXPIRED. THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE MENTIONED DEVICES USED WAS NOT PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 19790033 ↗
• MalfunctionApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, WHEN THE STENT WAS DILATED AT 12 ATM, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068949 ↗
• MalfunctionFeb 16, 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, WHEN TRIED TO REMOVE THE STENT GUARD, THE STENT ALLEGEDLY CAME OFF ALONG WITH THE STENT GUARD AND FELL OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719407 ↗
• MalfunctionOct 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DETACHED UPON ATTEMPTING TO REMOVE THE COVERED STENT GUARD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903607 ↗
• MalfunctionOct 9, 2023Material Rupture; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn; Material Rupture; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17893325 ↗
• MalfunctionOct 6, 2023Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON UPON REMOVING THE COVERED STENT GUARD. IT WAS FURTHER REPORTED THAT THE DISLODGED STENT WAS PUT ON THE BALLOON AND INSERTED INTO THE PATIENT. REPORTEDLY, THE BALLOON ALLEGEDLY RUPTURED AND THE STENT WAS FAILED TO BE PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885195 ↗
• MalfunctionJan 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF FROM THE BALLOON. BALLOON AND STENT WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143406 ↗
• MalfunctionNov 17, 2021Component Missing; Device Dislodged or Dislocated; Component Missing; Device Dislodged or Dislocated

  IT WAS REPORTED DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE STENT CAME OFF FROM THE BALLOON. IT WAS FURTHER REPORTED THAT STENT WAS MISSING ON THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828236 ↗
• MalfunctionJul 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY HAD A DISLODGEMENT ISSUE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10324861 ↗
• MalfunctionJul 14, 2020Device Dislodged or Dislocated; Packaging Problem; Device Dislodged or Dislocated; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO BALLOON EXPANDABLE STENT DEPLOYMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A PACKAGING ISSUE. IT WAS FURTHER REPORTED THAT, THE STENT CAME OFF WHEN THE DEVICE WAS PULLED OUT OF THE COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10269148 ↗
• MalfunctionJul 14, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED DURING A STENT GRAFT PLACEMENT IN THE FEMORAL ARTERY, THE DEVICE ALLEGEDLY MIGRATED INTO THE DISTAL FEMORAL ARTERY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10269146 ↗
• MalfunctionJan 9, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF THE ILIAC VIA GROIN ACCESS, THE DELIVERY SYSTEM ALLEGEDLY COULD NOT BE INSERTED THROUGH TWO DIFFERENT INTRODUCER SHEATHS AFTER A FEW ATTEMPTS. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572355 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FIRST TIME INTERVENTION VIA AN IPSILATERAL RIGHT COMMON FEMORAL APPROACH TO TREAT A VERY CALCIFIED ILIAC LESION FOR A PATIENT WITH ABNORMAL BRACHIAL INDEX (ABI), THE BALLOON EXPANDABLE VASCULAR COVERED STENT CATHETER WAS ALLEGEDLY DIFFICULT TO INSERT THROUGH A 6FR INTRODUCER SHEATH. HOWEVER, THE PROCEDURE WAS REPORTEDLY SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672266 ↗
• MalfunctionMay 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ADVANCEMENT TO THE LESION, THE COVERED STENT ALLEGEDLY DISLODGED FROM THE PTA BALLOON CATHETER. THE HEALTH CARE PROVIDER SUCCESSFULLY REMOVED THE COVERED STENT AND BALLOON FROM THE PATIENT AND USED ANOTHER STENT TO TREAT THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543093 ↗