LifeStream LSMU1350938Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05391522081260), received between Dec 6, 2017 and Dec 12, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE SUBCLAVIAN ARTERY VIA BRACHIAL ACCESS, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE STENT GRAFT ALLEGEDLY FLOATED INTO THE CAROTID ARTERY. REPORTEDLY, THE STENT WAS UNABLE TO BE RETRIEVED THUS DEPLOYED IN THE CAROTID ARTERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308458 ↗
• MalfunctionAug 1, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE PRODUCT BOX WAS ALLEGEDLY DAMAGED AND FOUND WET UPON OPENING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137431 ↗
• MalfunctionSep 25, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT IN THE ILIAC LESION, THE STENT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY 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 10585366 ↗
• MalfunctionFeb 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE VASCULAR COVERED STENT ALLEGEDLY DISLODGED FROM THE BALLOON AS IT WAS PASSED OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE COVERED STENT WAS RECANNULATED IN ANOTHER AREA OF THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352287 ↗
• InjuryDec 6, 2017Bent; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED AND MIGRATED REQUIRING A SURGICAL CUT DOWN TO REMOVE IT. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER AND THERE WAS NO DIFFICULTY REMOVING THE STENT COVER. THE PATIENT WAS TO BE TREATED FOR SUBCLAVIAN STENOSIS. THE COMPLAINT DEVICE WAS TO BE USED IN THE LEFT OSTIAL SUBCLAVIAN LESION. THE LESION WAS 40% CALCIFIED AND THERE WAS STENOSIS. THE LESION WAS TORTUOUS. FEMORAL ACCESS WAS MADE. A 7FR SHUTTLE, 90CM INTRODUCER SHEATH WAS USED. THE COMPLAINT DEVICE WAS PREPPED CORRECTLY AND DELIVERED OVER A 035 GUIDEWIRE THROUGH THE SHEATH TO THE TARGET LESION. THE TRACKING PATH WAS 40% CALCIFIED. THE STENT GRAFT WAS PROTECTED BY THE SHEATH DURING ALL STEPS OF TRACKING TO THE TARGET LESION. THERE WAS NO RESISTANCE FELT WHEN TRACKING THE DEVICE. THE 9X38 STENT WAS DECIDED TO BE TOO LONG TO TREAT THE LESION AND IT WAS THEREFORE DECIDED TO BE REMOVED. THE DEVICE WAS REMOVED OVER THE WIRE BACK THROUGH THE SHEATH. WHEN RETRACTING THE DEVICE THE STENT DISLODGED FROM THE BALLOON NEAR THE EDGE OF THE SHEATH. THERE WAS A BEND IN THE WIRE ALSO WHICH WAS THOUGHT MAY HAVE CONTRIBUTED TO THE DI

  Patient problems: Calcium Deposits/Calcification; Injury

  MAUDE report 7085972 ↗