LifeStream LSMU1350726Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05391522081130), received between Oct 23, 2017 and Jul 28, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (20 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM VIA RADIAL APPROACH. DURING THE PROCEDURE, WHEN INSERTING THE PRODUCT ALONG THE GUIDEWIRE RESISTANCE WAS ALLEGEDLY FOUND AT THE HEMOSTATIC VALVE OF THE SHEATH AND FAILED TO INSERT INTO THE SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639871 ↗
• MalfunctionJul 23, 2025Packaging Problem; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING LIFESTREAM DEVICE, PRIOR TO THE PROCEDURE, THE PACKAGES RECEIVED WAS ALLEGEDLY WET FROM INSIDE AND OUTSIDE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573565 ↗
• MalfunctionMay 13, 2025Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM. DURING THE PROCEDURE, THE SHEATH ALLEGEDLY FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007757 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PROCEDURE, AFTER OPENING THE PRODUCT, THE STENT WAS ALLEGEDLY FOUND TO HAVE FALLEN OFF DURING SETUP. IT WAS MISALIGNED FROM THE BALLOON MARKER AND HAD FALLEN OFF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880573 ↗
• MalfunctionDec 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COULD NOT BE INSERTED INTO THE INTRODUCER SHEATH, AND A STRONG RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891913 ↗
• MalfunctionNov 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FELL OUT WHEN IT WAS PULLED OUT OF THE PROTECTIVE SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703480 ↗
• MalfunctionSep 24, 2024Failure to Advance; Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated; Failure to Advance; Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, WHILE TRAPPING A BROKEN PIECE OF PREVIOUSLY PLACED COVERED STENT, THE STENT ALLEGEDLY HAD DIFFICULTY IN ADVANCING THROUGH THE SHEATH AND HAD DIFFICULTY IN TRAVERSING THE BIFURCATION. IT WAS FURTHER REPORTED THAT AS THE STENT HAD DIFFICULTY IN ADVANCING THROUGH THE SHEATH, THE STENT WAS REMOVED AND TRIED WITH DIFFERENT SHEATH, AND WHILE TRYING TO REMOVE THE CATHETER WHICH HAD NOT BEEN INFLATED, IT WAS FOUND THAT THE STENT HAD ALLEGEDLY DISLODGED FROM THE BALLOON. FURTHERMORE, THE STENT WAS RE-ADVANCED IN AN ATTEMPT TO REPOSITION THE STENT, WHICH WAS THEN DEPLOYED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289963 ↗
• MalfunctionSep 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA THE RADIAL APPROACH. THE STENT SYSTEM ALLEGEDLY DID NOT PASSED THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143185 ↗
• MalfunctionSep 4, 2024Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COULD NOT BE INSERTED INTO THE GUIDING SHEATH. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A DIFFICULTY WHILE REMOVING THE PROTECTIVE COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140785 ↗
• MalfunctionSep 4, 2024Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY COULD NOT BE INSERTED INTO THE GUIDING SHEATH. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY DIFFICULT TO REMOVE THE PROTECTIVE COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20132335 ↗
• MalfunctionJul 11, 2024Retraction Problem; Device-Device Incompatibility; Difficult to Advance; Difficult to Open or Remove Packaging Material; Retraction Problem; Device-Device Incompatibility; Difficult to Advance; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD STRONG RESISTANCE WHEN THE STENT PROTECTOR WAS REMOVED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD STRONG RESISTANCE FROM THE TIME OF INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727325 ↗
• MalfunctionJul 9, 2024Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, WHEN TRIED TO PULL OUT THE STENT COVER, THERE WAS ALLEGEDLY A TREMENDOUS RESISTANCE FELT, AND IT WAS REMOVED BY CLAMPING IT WITH FORCEPS. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY UNABLE TO BE INSERTED INTO THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699356 ↗
• MalfunctionJun 5, 2024Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DID NOT PASS THROUGH THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465300 ↗
• MalfunctionMay 6, 2024Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Material Deformation; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE PROTECTIVE SLEEVE WAS ALLEGEDLY STUCK TO THE CATHETER AND WOULD NOT COME OFF. IT WAS FURTHER REPORTED THAT THE SLEEVE WAS PULLED SO HARD THAT THE ACTUAL CATHETER ALLEGEDLY GOT SEPARATED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246000 ↗
• MalfunctionApr 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY GOT REMOVED WHEN THE PROTECTOR PROTECTING THE STENT WAS REMOVED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102645 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE CATHETER SHAFT ALLEGEDLY BROKE WHEN THEY WERE LOADING IT ON TO THE WIRE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976851 ↗
• MalfunctionFeb 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FROM THE RADIAL APPROACH, THE DEVICE ALLEGEDLY FELL OFF IN FRONT OF THE LESION. REPORTEDLY, THE DEVICE WAS INSIDE THE SHEATH AND WAS ABLE TO BE RETRIEVED SAFELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775717 ↗
• MalfunctionJul 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON ILIAC ARTERY, THE DEVICE WAS ALLEGEDLY UNABLE TO BE INSERTED INTO THE SHEATH. AFTER THAT, THE PHYSICIAN CHANGED THE SHEATH AND ATTEMPTED RE-INSERT, THEN THERE WAS A STRONG RESISTANCE FELT BUT THE DEVICE WAS ALLEGEDLY ABLE TO BE INSERTED INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408090 ↗
• MalfunctionApr 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE ILIAC ARTERY TO THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THERE WAS STRONG RESISTANCE FELT UPON INSERTION AND THE DEVICE ALLEGEDLY FAILED TO BE INSERTED INTO 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 16740433 ↗
• MalfunctionDec 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY WOULD NOT GO THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002777 ↗
• MalfunctionDec 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE STENT GRAFT PROCEDURE, THE STENT ALLEGEDLY CAME OFF IN THE PROTECTIVE COVER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922468 ↗
• MalfunctionAug 28, 2021Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED FROM THE CATHETER WHILE REMOVAL OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE STENT WAS ADVANCED FURTHER DOWN THE ARTERY AND DEPLOYED WHERE IT WAS NOT NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381213 ↗
• MalfunctionJul 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE STENT GRAFT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INSERT THROUGH THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10269153 ↗
• MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MESENTERY STENTING VIA LEFT BRACHIAL ACCESS, THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY FAILED TO ADVANCE THROUGH THE 6FR INTRODUCER SHEATH. THE PROCEDURE WAS RESCHEDULED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233548 ↗
• MalfunctionMay 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT OF THE SUBCLAVIAN ARTERY, THE STENT GRAFT ALLEGEDLY COULD NOT BE INSERTED THROUGH THE 6-FR INTRODUCER SHEATH UPON ACCESSING THE LEFT BRACHI. A NEW DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593495 ↗