LifeStream LSMU0800826Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05391522081178), received between Dec 19, 2018 and Feb 6, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE UTILIZING A LIFESTREAM STENT. DURING THE PROCEDURE, IT WAS REPORTED THAT WHEN THE HEALTH CARE PROFESSIONAL ATTEMPTED TO ADVANCE THE STENT INTO THE SHEATH, THE STENT SLIPPED OFF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275766 ↗
• MalfunctionSep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM. UPON REPOSITIONING, IT WAS CONFIRMED THAT THE STENT HAD DISLODGED FROM THE SHEATH. THE GUIDING SHEATH WAS REMOVED AND REINSERTED, AFTER WHICH A STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975122 ↗
• MalfunctionJun 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM. PRIOR TO THE PROCEDURE, THE STENT ALLEGEDLY BECAME LOOSE ON BALLOON AND SLID BACK ON THE CATHETER WHEN TRYING TO ADVANCE IT THROUGH A 7F SHEATH. ATTEMPTED TO RE-SECURE THE STENT ON THE BALLOON, IT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125773 ↗
• MalfunctionOct 6, 2024Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT FEMORAL ARTERY LESION VIA THE CONTRALATERAL APPROACH, THE STENT ALLEGEDLY HAD STRONG RESISTANCE WHILE ENTERING AT THE HEMOSTATIC VALVE OF THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY HAD MISALIGNMENT WITH THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380318 ↗
• MalfunctionNov 15, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DIFFICULT TO BE DELIVERED WITH THE SHEATH PROTECTION. IT WAS FURTHER REPORTED THAT THE STENT WHICH HAD TO BE ADVANCED BARE WAS ALLEGEDLY MISALIGNED WITH THE MOUNTING BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138036 ↗
• MalfunctionOct 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DETACHED FROM THE BALLOON IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624394 ↗
• MalfunctionSep 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15452998 ↗
• MalfunctionJul 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DISLODGED UPON RETRACING BECAUSE THE PHYSICIAN FOUND MISTAKE SIZE CHOOSE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109914 ↗
• MalfunctionJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE MESENTERIC ARTERY VIA CALCIFIED AND TORTUOUS RIGHT COMMON FEMORAL ACCESS, THE STENT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM WHILE ADVANCING TO THE LESION; AS A RESULT, THE STENT GRAFT WAS SNARED AND REMOVED FROM THE BODY. IT WAS FURTHER REPORTED THAT NO ADDITIONAL STENTS WERE USED TO COMPLETE THE PROCEDURE DUE TO THE DEGREE OF CALCIFICATION IN THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737574 ↗
• MalfunctionDec 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY, THE BALLOON EXPANDABLE VASCULAR COVERED STENT DELIVERY SYSTEM FAILED TO INSERT THROUGH THE VALVE OF A 7X45 INTRODUCER SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8181190 ↗