LifeStream LSMU0800737Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05391522081109), received between Jun 14, 2017 and Dec 13, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY HAD A HOLE IN IT. THE PROCEDURE WAS COMPLETED BY RELINING THE ORIGINAL STENT WITH ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923017 ↗
• MalfunctionOct 21, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT COMMON ILIAC ARTERY VIA THE LEFT COMMON FEMORAL ARTERY APPROACH, THERE WAS TOO MUCH RESISTANCE FELT AND THE STENT GRAFT WAS ALLEGEDLY FAILED TO BE ADVANCED AFTER EXITING THE SHEATH. IT WAS FURTHER REPORTED THAT AFTER REMOVAL OF THE DELIVERY SYSTEM AND THE STENT TOGETHER WITH THE SHEATH, IT WAS FOUND THAT THE STENT GRAFT WAS ALLEGEDLY REMAINED ON THE GUIDEWIRE NOT ON THE BALLOON ITSELF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982002 ↗
• MalfunctionAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY DISLODGED FROM THE STENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181754 ↗
• InjuryAug 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER STENT GRAFT IMPLANTATION, THE PATIENT ALLEGEDLY DEVELOPED A RASH ON THE RIGHT LEG WHERE THE DEVICE WAS PLACED.

  Patient problems: Rash

  MAUDE report 8855130 ↗
• InjuryJun 14, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND A SNARE WAS USED TO REPOSITION THE STENT. 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 TARGET LESION AS THE LEFT COMMON ILIAC ARTERY. THE VESSEL AND TRACKING PATH WERE NOT TORTUOUS OR CALCIFIED. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM AT THE LEFT COMMON ILIAC ARTERY. A 0.035, 260CM AMPLATZ GUIDEWIRE AND A 7F, 10CM CORDIS SHEATH WAS USED. A CONTRALATERAL APPROACH WAS MADE. THE DEVICE WAS ADVANCED AND NO RESISTANCE WAS FELT DURING DEVICE TRACKING TO THE LESION. THE STENT DISLODGED OUTSIDE OF THE SHEATH WHILE THE HEALTH CARE PROVIDER ATTEMPTED TO REPOSITION THE DELIVERY SYSTEM IN AN 8MM VESSEL. A SNARE WAS USED TO REPOSITION THE STENT NEAR THE INTENDED PLACEMENT SITE IN THE ILIAC. THE SNARE CATHETER ENGAGED THE INNER PORTION OF THE STENT AND THIS ALLOWED A 0.018 GUIDEWIRE TO BE FED THROUGH THE STENT AND AN ULTRAVERSE DEVICE PASSED THROUGH. THE BALLOON WAS INFLATED SLIGHTLY AND THE STENT WAS CAPTURED. THE STENT WAS THEN IMPLANTED AT THE TARGET LESION. THERE WAS NO REPORTED ISSUES I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639954 ↗