LifeStream LSMU1350637Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05391522081062), received between Sep 28, 2017 and Jul 19, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (26 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25867868 ↗
• MalfunctionJun 10, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. DURING THE PROCEDURE, THE STENT DISLODGED FROM THE BALLOON BEFORE REACHING THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25454164 ↗
• 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 22573559 ↗
• InjuryJun 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM AND DURING THE PROCEDURE THE STENT ALLEGEDLY FELL OUT DURING DELIVERY. THE FALLEN STENT WAS PLACED IN THE SFA AND FELL OUT. PLACEMENT WAS COMPLETED USING A DIFFERENT SIZE LIFESTREAM. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22121472 ↗
• MalfunctionApr 29, 2025Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE LSMU STENT DID NOT PASS THROUGH THE CIA LESION AT TRI. IT WAS FURTHER REPORTED THAT THE STENT WAS CAUGHT IN THE LESION AND TURNED UP. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924839 ↗
• MalfunctionApr 16, 2025Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING A STENT GRAFT PROCEDURE USING THE LIFESTREAM CATHETER TO TREAT A PSEUDOANEURYSM AND SEVERE STENOSIS IN THE LEFT CIA. THE CONTRALATERAL APPROACH WAS FROM THE RIGHT CFA, BUT THE BIFURCATION WAS STEEP, AND IT WAS DIFFICULT TO GET THE SHEATH OVER THE MOUNTAIN. WHEN ALIGNING THE LESION, THE STENT FELL OFF AND STOPPED JUST BEFORE THE CFA. THERE WAS STRONG RESISTANCE WHEN BRINGING THE SHEATH TO THE CONTRALATERAL SIDE, AND RESISTANCE WHEN CROSSING THE BIFURCATION WITH THE INSHEATH DELIVERY OF THE STENT. AFTER THAT, A SMALL-DIAMETER BALLOON WAS INSERTED INTO THE STENT AND PULLED UP. AFTER THAT, A NEW BALLOON OF THE SAME SIZE WAS DELIVERED AND SUCCESSFULLY PLACED IN THE RESPONSIBLE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851966 ↗
• MalfunctionApr 15, 2025Device Dislodged or Dislocated; Material Deformation; Material Twisted/Bent; Device Dislodged or Dislocated; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO PLACEMENT PROCEDURE DURING DEVICE PREPARATION, THE STENT ALLEGEDLY DISLODGED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY BENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838792 ↗
• MalfunctionDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR A STENT GRAFT PLACEMENT PROCEDURE; AFTER REMOVING THE PROTECTIVE COVER, THE STENT GRAFT ALLEGEDLY FELL OUT OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911452 ↗
• MalfunctionOct 17, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY, THE STENT ALLEGEDLY FLOATED TO THE EXTERNAL ILIAC ARTERY. IT WAS FURTHER REPORTED THAT AN ATTEMPT WAS MADE TO PULL THE STENT UP TO THE COMMON ILIAC ARTERY WITH A SIX-MILLIMETER BALLOON, BUT IT WAS UNSUCCESSFUL. MOREOVER, THE EXTERNAL ILIAC ARTERY HAD A MILD STENOSIS, WHICH WAS NOT PLANNED FOR TREATMENT, SO, THE MIGRATED STENT WAS PLACED THERE IN ACCORDANCE WITH THIS SITE OF LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468977 ↗
• InjuryAug 26, 2024Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POST STENTING OF BOTH COMMON ILIAC ARTERIES AND RIGHT EXTERNAL ILIAC ARTERY, THE PATIENT ALLEGEDLY DEVELOPED A HEMATOMA IN LEFT GROIN, A LEAKAGE WAS IDENTIFIED, AND A STENT GRAFT WAS PLANNED TO BE PLACED. HOWEVER, DURING THE STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DISLODGED. AFTER SEVERAL ATTEMPTS, THE DISLODGED STENT WAS ALLEGEDLY REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20062724 ↗
• MalfunctionMay 13, 2024Retraction Problem; Device-Device Incompatibility; Device Dislodged or Dislocated; Retraction Problem; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT SUPERFICIAL ARTERY VIA LEFT GROIN ACCESS, ALLEGED RESISTANCE WAS MET WHILE THE CATHETER WAS ADVANCED THROUGH THE INTRODUCER SHEATH, SO THEY PULLED BACK ON THE SHEATH AND NOTICED THE STENT GRAFT WAS NO LONGER ON THE CATHETER. IT WAS FURTHER REPORTED THAT THE SHEATH WAS REMOVED AND COULD NOT ADVANCE THE DILATOR. REPORTEDLY, THERE WAS LITTLE DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT. A NEW INTRODUCER SHEATH AND CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296739 ↗
• MalfunctionMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE MOUNTED STENT ALLEGEDLY CAME OFF THE BALLOON WHEN REMOVED FROM PACKAGING ON BACK ON TABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835684 ↗
• MalfunctionFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791112 ↗
• MalfunctionFeb 20, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA RADIAL APPROACH, THE DEVICE HAD SLIGHT RESISTANCE AT THE LESION AND ALLEGEDLY DID NOT ADVANCE. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FELL OUT OF THE MOUNTING BALLOON. THE AREA WAS DILATED AND STENT BODY WAS PUSHED UP WITH A DISTAL BALLOON TO MOVE THE STENT TO THE AREA OF IMPLANT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738573 ↗
• MalfunctionJan 31, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FELL OFF WHEN IT WAS REMOVED FROM THE PROTECTIVE COVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615233 ↗
• MalfunctionJan 18, 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 COMMON ILIAC ARTERY THROUGH IPSILATERAL RETROGRADE APPROACH, THE DEVICE ALLEGEDLY COULD NOT CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY MOUNTED JUST BEFORE THE LESION WAS DISPLACED BY ABOUT HALF OF THE BALLOON. REPORTEDLY, THE DEVICE HAS NOT BEEN REMOVED AS THE ATTEMPT TO RETRIEVE WAS NOT POSSIBLE AS THERE WAS CHANCE OF STENT FALL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533752 ↗
• MalfunctionJan 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA BRACHY ACCESS, THE MOUNTED STENT ALLEGEDLY FELL OUT WHEN THE PROTECTOR WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490626 ↗
• MalfunctionDec 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FELL OUT OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290518 ↗
• MalfunctionOct 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE IN THE ILIAC VIA THE FEMORAL ACCESS, THE STENT ALLEGEDLY CAME OFF OF THE BALLOON AND REMAINED LODGED IN THE PROTECTIVE SLEEVE OVER THE BALLOON AND STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18043845 ↗
• MalfunctionApr 22, 2022Difficult 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 A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF WHEN THE YELLOW PROTECTOR WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14184517 ↗
• MalfunctionAug 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON WITHOUT FORCING OR DILATING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300624 ↗
• MalfunctionJul 16, 2020Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY EXPERIENCED DIFFICULTY IN ADVANCING. THERE WAS NO PATIENT CONTACT.

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

  MAUDE report 10282523 ↗
• MalfunctionDec 24, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE MESENTERIC ARTERY, THE HEALTHCARE PROVIDER (HCP), AWARE OF THE OFF-LABEL INDICATION FOR USE, PREDILATED THE LESION AND ADVANCED THE BALLOON EXPANDABLE VASCULAR COVERED STENT WHEN IT BECAME STUCK. IT WAS FURTHER REPORTED THAT UPON ATTEMPT TO PULL IT BACK, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE INSIDE THE SHEATH. THE DELIVERY SYSTEM AND INTRODUCER SHEATH WERE REMOVED. THE PROCEDURE WAS COMPLETED BY PERFORMING ANGIOPLASTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516527 ↗
• MalfunctionDec 24, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE MESENTERIC ARTERY, THE HEALTHCARE PROVIDER (HCP), AWARE OF THE OFF-LABEL INDICATION FOR USE, PREDILATED THE LESION AND ADVANCED THE BALLOON EXPANDABLE VASCULAR COVERED STENT WHEN IT BECAME STUCK ON THE EDGE OF THE MESENTERIC ARTERY. IT WAS FURTHER REPORTED THAT UPON ATTEMPT TO PULL IT BACK, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON AND EMBOLIZED DOWN THE LEG TO THE PROFUNDA. THE STENT WAS UNABLE TO BE RETRIEVED AND NO FURTHER ATTEMPTS WILL BE MADE AS IT WAS DETERMINED THAT THE LOCATION OF THE EMBOLIZED STENT DOES NOT POSE AS A HEALTH HAZARD TO THE PATIENT. THE PROCEDURE WAS COMPLETED BY PERFORMING ANGIOPLASTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516524 ↗
• MalfunctionAug 22, 2019Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE ILIAC ARTERY VIA COMMON FEMORAL ARTERY APPROACH, THE DELIVERY SYSTEM WAS ALLEGEDLY STUCK IN THE INTRODUCER SHEATH AND THE STENT DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM WAS REMOVED WITH THE INTRODUCER SHEATH AND ANOTHER DEVICE OF A DIFFERENT MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8921584 ↗