LifeStream LSMU1350837Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05391522081222), received between Jul 3, 2018 and Jun 23, 2026 — classified as 1 death, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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.

• MalfunctionJun 23, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTREAM DEVICE. DURING INSERTION, WHILE ADVANCING THE DEVICE INTO A SEVENTH FRENCH COOK ANSEL SHEATH, THE STENT BECAME DISLODGED FROM THE BALLOON WHILE BEING ADVANCED INTO THE SHEATH. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592971 ↗
• MalfunctionJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, WHEN THE STENT GUARD WAS REMOVED, THE STENT WAS ALLEGEDLY SHIFTED AND WAS UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462699 ↗
• MalfunctionNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129029 ↗
• MalfunctionSep 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DETACHED FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669833 ↗
• InjuryJul 24, 2023Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT COMMON ILIAC ARTERY VIA THE RIGHT FEMORAL ACCESS, THE STENT WAS ALLEGEDLY FOUND TO HAVE MIGRATED INTO THE AORTA. IT WAS FURTHER REPORTED THAT THE PHYSICIAN MAY HAVE UNDERSIZED THE FIRST STENT, AND THEN THE SECOND STENT BECAME ATTACHED TO THE FIRST, AND THEN BOTH MIGRATED UPWARD. IT WAS ALSO REPORTED THAT THE STENT BALLOON WAS INFLATED INSIDE THE STENT IN AN ATTEMPT TO PULL IT BACK DOWN. FURTHERMORE, ATTEMPTS WERE MADE TO SNARE THE STENT WITH NO SUCCESS. REPORTEDLY, SURGERY WAS CONSULTED, AND A COMPLETE CUTDOWN WAS DONE TO ACCESS THE ILIACS AND AORTA TO RETRIEVE THE STENTS THAT MIGRATED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 17378043 ↗
• InjuryJul 24, 2023Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC ARTERY, THE STENT WAS ALLEGEDLY FOUND TO HAVE MIGRATED UPWARDS. IT WAS FURTHER REPORTED THAT THE PHYSICIAN MAY HAVE UNDERSIZED THE FIRST STENT, AND THEN THE SECOND STENT BECAME ATTACHED TO THE FIRST, AND THEN BOTH MIGRATED UPWARD. IT WAS ALSO REPORTED THAT THE STENT BALLOON WAS INFLATED INSIDE THE STENT IN AN ATTEMPT TO PULL IT BACK DOWN. FURTHERMORE, ATTEMPTS WERE MADE TO SNARE THE STENT WITH NO SUCCESS. REPORTEDLY, SURGERY WAS CONSULTED, AND A COMPLETE CUTDOWN WAS DONE TO ACCESS THE ILIACS AND AORTA TO RETRIEVE THE STENT THAT MIGRATED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 17377184 ↗
• MalfunctionMar 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY CAME OFF INSIDE OF THE GREEN PROTRACTOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590521 ↗
• MalfunctionJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY LOOSENED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101423 ↗
• MalfunctionJul 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE IN THE ILIAC ARTERY, THE STENT ALLEGEDLY CAME 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 15025672 ↗
• MalfunctionJul 6, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT IN THE HEAVILY CALCIFIED ILIAC ARTERY, THE STENT GRAFT ALLEGEDLY FAILED TO CROSS. IT WAS FURTHER REPORTED THAT, THE STENT CAME OFF WHEN THE DEVICE WAS PULLED OUT OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10231573 ↗
• InjuryMar 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA LEFT BRACHIAL ACCESS THE STENT GRAFT ALLEGEDLY DISLODGED WHILE RETRACTING THE DELIVERY SYSTEM. FURTHERMORE, A SNARE WAS USED TO RETRIEVE THE DEVICE AND THE SUBCLAVIAN ARTERY WAS DISSECTED. REPORTEDLY, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8461738 ↗
• DeathAug 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING INFLATION OF THE PTA BALLOON CATHETER TO TREAT A LESION IN THE LEFT ILIAC ARTERY VIA A RIGHT COMMON FEMORAL APPROACH, THE BALLOON EXPANDABLE COVERED STENT ALLEGEDLY DISLOCATED FROM THE BALLOON CATHETER. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER EXCHANGED THE BALLOON CATHETER OVER THE GUIDE WIRE FOR ANOTHER AND WAS ABLE TO POSITION AND EXPAND THE COVERED STENT IN SITU; HOWEVER, THE STENT WAS NOT POSITIONED AT THE LESION SITE. NO FURTHER TREATMENT WAS PROVIDED AND THE PROCEDURE WAS CONCLUDED. REPORTEDLY, THE PATIENT EXPIRED APPROXIMATELY 3-4 HOURS POST PROCEDURE. THE CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT.

  Patient problems: Death

  MAUDE report 7793970 ↗
• MalfunctionJul 3, 2018Occlusion Within Device; Obstruction of Flow; Occlusion Within Device; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY THREE YEARS POST STENT PLACEMENT IN THE RIGHT COMMON ILIAC ARTERY, ULTRASOUND DEMONSTRATED IN STENT STENOSIS. NO REPORTED INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659219 ↗