LifeStream LSMU1350526Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05391522080980), received between Dec 6, 2017 and Dec 12, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 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, THE STENT GRAFT ALLEGEDLY BECAME DISLODGED WHILE REMOVING THE PROTECTIVE COVER. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULT IN REMOVING THE PROTECTIVE COVER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20910319 ↗
• InjuryJul 25, 2024Migration or Expulsion of Device; Difficult to Remove; Device Dislodged or Dislocated; Migration or Expulsion of Device; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, STENT WAS ALLEGEDLY PARTIALLY EXPOSED OUTSIDE OF THE SHEATH IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DID NOT PULL ALL THE WAY BACK INTO THE SHEATH. FURTHERMORE, THE STENT ALLEGEDLY CAME OFF THE WIRE AND MIGRATED INTO SUPERIOR FEMORAL ARTERY. REPORTEDLY, A SNARE WAS USED TO REMOVE THE STENT GRAFT AFTER A SURGICAL CUT DOWN WAS PERFORMED. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

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

  MAUDE report 19824446 ↗
• MalfunctionJul 23, 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 CAME OFF THE BALLOON. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS ALLEGEDLY SNARE AND BROUGHT DOWN TO AN ILIAC ARTERY AND CRUSHED AGAINST THE ILIAC ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803450 ↗
• MalfunctionApr 11, 2024Migration or Expulsion of Device; Failure to Advance; Migration or Expulsion of Device; Failure to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN DISTAL END OF THE RIGHT EXTERNAL ILIAC, THE DEVICE WAS ALLEGEDLY UNABLE TO CROSS THE LESION, EVEN AFTER SHOCKWAVE HAD BEEN USED. THE DEVICE WAS PUSHED BEYOND THE LESION OUTSIDE OF THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT HAD ALLEGEDLY MOVED FROM RETROGRADE OR PROXIMAL TO LESION LOCATION JUST BY ABOUT TEN MILLIMETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085973 ↗
• MalfunctionAug 17, 2022Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AORTA, THE STENT ALLEGEDLY DISLODGED FROM THE PTA BALLOON AND ALSO HAD INCOMPATIBILITY ISSUES. THE PROCEDURE WAS COMPLETED USING SAME BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238613 ↗
• MalfunctionMay 25, 2022Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH FEMORAL REGION, THE STENT ALLEGEDLY GOT STUCK IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496860 ↗
• MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DISLODGED. 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 13281962 ↗
• MalfunctionJan 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DISLODGED. 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 13263822 ↗
• MalfunctionDec 25, 2021Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY STUCK INSIDE THE SHEATH UPON INSERTION. THE PROCEDURE WAS COMPLETED BY ACCESSING FROM THE OTHER SIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085499 ↗
• MalfunctionDec 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY CAME OFF OF THE BALLOON WHILE THEY WERE ADVANCING THE CATHETER THROUGH A TIGHT LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12997841 ↗
• MalfunctionOct 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PREPARATION OF AN STENT GRAFT PLACEMENT, THE STENT GRAFT ALLEGEDLY DISMOUNTED FROM THE BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632523 ↗
• MalfunctionFeb 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON UPON AN ATTEMPT TO INTRODUCE THROUGH THE VALVE OF A 6FR INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8341858 ↗
• MalfunctionFeb 1, 2019Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE VASCULAR STENT GRAFT DELIVERY SYSTEM ALLEGEDLY FAILED TO ADVANCE MORE THAN HALFWAY THROUGH A 6FR INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT UPON REMOVAL, THE BALLOON EXPANDABLE VASCULAR STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON INSIDE THE INTRODUCER SHEATH. THEREFORE, THE DELIVERY SYSTEM AND INTRODUCER SHEATH WERE REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298928 ↗
• MalfunctionSep 21, 2018Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON, BUT REMAINED ON THE BALLOON CATHETER, WHILE PASSING THROUGH THE HEMOSTATIC VALVE OF A 6 FR SHEATH (BRAND UNKNOWN). THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898136 ↗
• MalfunctionApr 11, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY THIRTY-SIX MONTHS POST STENT GRAFT PLACEMENT IN THE RIGHT EXTERNAL ILIAC ARTERY, DUPLEX ULTRASOUND DEMONSTRATED STENOSIS JUST PROXIMAL TO THE PROXIMAL EDGE OF THE STENT. THERE WAS NO REPORTED INTERVENTION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7423866 ↗
• MalfunctionDec 8, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED. DURING ADVANCEMENT INTO A SEVERELY CALCIFIED LESION, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON; THEREFORE, THE BALLOON DELIVERY SYSTEM AND THE STENT WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7099366 ↗
• MalfunctionDec 6, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED FROM THE DEVICE WHEN ATTEMPTING TO PULL IT BACK THROUGH THE SHEATH. A 6.5F MEDTRONIC TOUR GUIDE INTRODUCER SHEATH WAS USED. THE TARGET LESION WAS THE SMA. THE COMPLAINT DEVICE WAS PREPPED CORRECTLY AND DELIVERED TO THE TARGET LESION OVER A 0.035 GUIDEWIRE. THE DOCTOR DECIDED THAT A STIFFER GUIDEWIRE WOULD BE REQUIRED FOR DEPLOYMENT SO AN ATTEMPT WAS MADE TO RETRACT THE LIFESTREAM DEVICE. WHEN THE CATHETER WAS BEING BACKED OUT OF THE SHEATH THE STENT DISLODGED FROM THE BALLOON COMPLETELY. IT WAS HALF WAY OUT OF THE VALVE AND WAS VISIBLE TO REMOVE. ANOTHER LIFESTREAM DEVICE WAS USED WITH THE NEW GUIDEWIRE IN THE SMA AND THE PROCEDURE WAS A SUCCESS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085962 ↗