LifeStream LSMU1350858Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05391522081239), received between Oct 17, 2017 and Aug 16, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2024Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RADIAL NERVE, THE STENT GRAFT ALLEGEDLY CAME OFF THE BALLOON. IT WAS FURTHER REPORTED THAT THERE WERE SOME DIFFICULTIES IN RETRACTING THE DEVICE. REPORTEDLY, THE STENT WAS RETRIEVED THROUGH A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997719 ↗
• MalfunctionSep 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, STENT ALLEGEDLY FELL OFF THE BALLOON ON THE WAY TO THE TARGET. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460558 ↗
• MalfunctionAug 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STENT ALLEGEDLY BROKE INTO TWO SEGMENTS. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181643 ↗
• MalfunctionMar 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC ARTERY VIA IPSILATERAL RETROGRADE APPROACH, THE CATHETER ALLEGEDLY GOT STUCK IN THE TORTUOUS EXTERNAL ILIAC ARTERY DURING ADVANCEMENT AND THE STENT CAME OFF FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13730251 ↗
• MalfunctionOct 15, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE SIZE AND THE LOT NUMBER OF THE DEVICE WAS NOT FOUND TO BE THE SAME AS MENTIONED ON THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10687133 ↗
• MalfunctionJun 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10172910 ↗
• MalfunctionJun 16, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE STENT WAS DEPLOYED FROM THE BALLOON. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Not Applicable

  MAUDE report 10157213 ↗
• MalfunctionAug 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT TO TREAT A SUBCLAVIAN VEIN LESION VIA RIGHT FEMORAL ACCESS USING AN 8F SHEATH THE STENT ALLEGEDLY CAME OFF THE CATHETER. REPORTEDLY, THE STENT WAS RETRIEVED USING A SNARE RETRIEVAL SYSTEM. A NEW STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913136 ↗
• MalfunctionAug 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE LEFT COMMON FEMORAL ARTERY, THE DELIVERY SYSTEM WAS ALLEGEDLY UNABLE TO LOAD THROUGH THE GUIDEWIRE. REPORTEDLY, THE DEVICE WAS REPLACED WITHOUT ISSUES AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814449 ↗
• MalfunctionAug 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDEWIRE ALLEGEDLY WOULD NOT EXIT THE HUB OF THE BALLOON EXPANDABLE COVERED STENT DELIVERY SYSTEM. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813675 ↗
• InjuryJan 22, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER INSIDE THE PATIENT AND HAD TO BE DEPLOYED AT THE SITE OF DISLODGMENT. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER AND THE STENT COVER WAS EASILY REMOVED WITHOUT ANY ISSUE. THE PATIENT WAS BEING TREATED FOR LEFT ILIAC STENOSIS. THE LESION WAS A CLASS C LESION. ACCESS WAS MADE VIA THE RIGHT AND LEFT COMMON FEMORAL ARTERY. THE AREA WAS CALCIFIED AND WAS PRE-DILATED WITH MULTIPLE BALLOON CATHETERS PRIOR TO INSERTING THE COMPLAINT DEVICE AND A SECOND LIFESTREAM DEVICE. TWO TERUMO 260CM GLIDEWIRE ADVANTAGE GUIDEWIRES AND A TERUMO 7FX25CM DESTINATION SHEATH WERE USED. THE COMPLAINT DEVICE WAS INSERTED AND THERE WAS MILD RESISTANCE FELT WHEN INSERTING THE DEVICE INTO THE SHEATH. THE DEVICE WAS UNABLE TO CROSS THE LESION AND WHEN THE DEVICE WAS ATTEMPTED TO BE REMOVED THE STENT DISLODGED OUTSIDE OF THE SHEATH. THE STENT THEN HAD TO BE DEPLOYED 10 TO 15MM BELOW THE INTENDED TREATMENT SITE. THE STENT GRAFT WAS PROTECTED BY THE SHEATH WHEN TRACKING TO THE LESION. AIR EVACUATION WAS PERFORMED PRIOR TO INSERTION. A SECOND LIFESTREAM STENT WAS INS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7208865 ↗
• InjuryJan 18, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER INSIDE THE PATIENT AN HAD TO BE DEPLOYED AT THE SITE OF DISLODGMENT. REPORTEDLY, ANOTHER BALLOON EXPANDABLE VASCULAR COVERED STENT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7203158 ↗
• InjuryOct 17, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED IN THE PATIENT BODY. THE TARGET LESION WAS THE COMMON ILIAC ARTERY. THE HEALTH CARE PROVIDER WAS PREPARING TO DEPLOY THE STENT HOWEVER IT WAS IDENTIFIED THAT THE STENT HAD ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER. THEREFORE, A SMALLER DIAMETER BALLOON CATHETER WAS USED TO SECURE THE STENT AGAINST THE VESSEL WALL. REPORTEDLY, ANOTHER STENT WAS THEN UTILIZED FOR THE PROXIMAL COMMON ILIAC ARTERY AND DEPLOYED WITHOUT ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6954808 ↗