LifeStream LSMU1350616Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05391522081468), received between Aug 16, 2017 and Jul 9, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• InjuryJul 9, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE FOR LEFT RENAL ARTERY STENOSIS. PRE DEPLOYMENT EVALUATION DEMONSTRATED THAT THE LESION WAS HIGHLY FOCAL, WITH A SIGNIFICANT PORTION OF THE STENT EXPECTED TO EXTEND INTO THE AORTA. AT THAT POINT, A DECISION WAS MADE TO REMOVE THE DEVICE AND USE ANOTHER STENT. THE STENT WAS WITHDRAWN, AND INSPECTION REVEALED THAT IT HAD DISLODGED FROM THE BALLOON WITHIN THE LEFT RENAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE STENT; HOWEVER, THESE WERE UNSUCCESSFUL. THE STENT ULTIMATELY BECAME LODGED IN A SEGMENTAL BRANCH OF THE RENAL ARTERY, WHICH HAD SPASMED AROUND IT, RENDERING IT UNRETRIEVABLE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 25769149 ↗
• MalfunctionJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM. IT WAS REPORTED THAT DURING TO THE PROCEDURE, THE SENT ALLEGEDLY DISLODGED PRIOR TO INSERTING INTO SHEATH. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368605 ↗
• MalfunctionJul 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT, THE STENT ALLEGEDLY CAME OFF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263066 ↗
• MalfunctionJul 13, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE STENT PROCEDURE IN CELIAC CURVE THROUGH COMMON FEMORAL ACCESS, THE STENT GRAFT ALLEGEDLY DISLODGED WITHIN THE INTRODUCER SHEATH FROM THE BALLOON DELIVERY SYSTEM. ANOTHER DEVICE AND SAME SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 10263040 ↗
• MalfunctionSep 10, 2019Retraction Problem; Failure to Advance; Device Dislodged or Dislocated; Retraction Problem; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING OFF-LABEL TREATMENT OF THE CALCIFIC CELIAC ARTERY VIA RIGHT GROIN ACCESS, THE BALLOON EXPANDABLE VASCULAR COVERED STENT DELIVERY SYSTEM ALLEGEDLY FAILED TO CROSS THE LESION. THEREFORE, THE HEALTH CARE PROVIDER (HCP) DECIDED TO REMOVE THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH, CAUSING THE STENT GRAFT TO ALLEGEDLY PARTIALLY DISLODGE FROM BALLOON AT THE HEMOSTATIC VALVE. REPORTEDLY, THE STENT GRAFT AND THE DELIVERY SYSTEM WERE REMOVED AS ONE UNIT THROUGH THE INTRODUCER SHEATH WITH SOME DIFFICULTY. ANOTHER PTA BALLOON CATHETER AND ANOTHER DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982405 ↗
• InjuryAug 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AS THE DEVICE WAS PULLED BACK TO REPOSITION IT, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE CATHETER UNINTENTIONALLY IN THE ILIAC VIA A CONTRALATERAL APPROACH. IT WAS FURTHER REPORTED THAT THE VESSEL WAS PERFORATED AND A SECOND STENT WAS PLACED TO TAMPONADE THE VESSEL AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7803102 ↗
• MalfunctionAug 22, 2017Sticking; Physical Resistance

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN A 6FR COOK ANSEL SHEATH DURING ADVANCEMENT INTO THE LESION. THE DOCTOR PREPPED THE DEVICE. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER AND NO DIFFICULTY REMOVING THE STENT COVER. THE PATIENT WAS BEING TREATED FOR SMA STENOSIS MESENTERIC ISCHEMIA. A 6F, 45CM ANSEL 2 INTRODUCER SHEATH AND A 0.035, 260CM ROSEN GUIDEWIRE WERE USED. THE DEVICE WAS ATTEMPTED TO BE INSERTED THROUGH THE 6F SHEATH HOWEVER RESISTANCE WAS FELT JUST PAST THE VALVE OF THE SHEATH. AN ATTEMPT WAS MADE TO RETRACT THE DEVICE FROM THE SHEATH HOWEVER THIS WAS UNSUCCESSFUL AS THE STENT WAS STUCK. THE STENT REMAINED STUCK IN THE INTRODUCER SHEATH. AIR EVACUATION WAS NOT PERFORMED PRIOR TO INSERTING THE DEVICE. MULTIPLE ATTEMPTS TO INSERT THE DEVICE WERE NOT MADE. THERE WAS NO REPORTED PATIENT INJURY. HOWEVER, THE ACCESS SITE WAS LOST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810362 ↗
• MalfunctionAug 16, 2017Sticking; Physical Resistance

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN A 6FR COOK ANSEL SHEATH DURING ADVANCEMENT INTO THE LESION. THE DOCTOR PREPPED THE DEVICE. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER AND NO DIFFICULTY REMOVING THE STENT COVER. THE PATIENT WAS BEING TREATED FOR SMA STENOSIS MESENTERIC ISCHEMIA. A 6F, 45 CM ANSEL 2 INTRODUCER SHEATH AND A 0.035, 260 CM ROSEN GUIDEWIRE WERE USED. THE DEVICE WAS ATTEMPTED TO BE INSERTED THROUGH THE 6F SHEATH HOWEVER RESISTANCE WAS FELT JUST PAST THE VALVE OF THE SHEATH. AN ATTEMPT WAS MADE TO RETRACT THE DEVICE FROM THE SHEATH HOWEVER THIS WAS UNSUCCESSFUL AS THE STENT WAS STUCK. THE STENT REMAINED STUCK IN THE INTRODUCER SHEATH. AIR EVACUATION WAS NOT PERFORMED PRIOR TO INSERTING THE DEVICE. MULTIPLE ATTEMPTS TO INSERT THE DEVICE WERE NOT MADE. THERE WAS NO REPORTED PATIENT INJURY. HOWEVER, THE ACCESS SITE WAS LOST.

  Patient problems: Ischemia

  MAUDE report 6797689 ↗