LifeStream LSMU0800958Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05391522081253), received between Feb 16, 2022 and Sep 2, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025 A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT WHEN OPENING THE PACKAGE AND REMOVING THE BALLOON PROTECTOR, IT WAS DISCOVERED THAT THE STENT MOUNTED ON THE BALLOON HAD ALLEGEDLY FALLEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929941 ↗
• MalfunctionMar 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705176 ↗
• MalfunctionMar 27, 2025Retraction Problem; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Retraction Problem; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY, THE DELIVERY SYSTEM ALLEGEDLY HAD STRONG RESISTANCE TO REMOVE THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THERE WAS STRONG RESISTANCE IN ADVANCING THE DELIVERY SYSTEM THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705094 ↗
• MalfunctionOct 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA FEMORAL ACCESS, THE STENT GRAFT ALLEGEDLY DID NOT GO IN THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AFTER REPLACING THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397183 ↗
• MalfunctionOct 8, 2024Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DID NOT GO IN THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A RESISTANCE WHILE REMOVING THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AFTER REPLACING THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396822 ↗
• MalfunctionJul 17, 2024Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT PRIOR A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY UNABLE TO BE INSERTED INTO THE SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767974 ↗
• MalfunctionJun 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DROPPED OUT WHEN THE PROTECTOR COVER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580562 ↗
• MalfunctionJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA GROIN ACCESS, THE STENT ALLEGEDLY CAME OFF OF THE BALLOON WHILE ADVANCING IT THROUGH THE COMMON ILIAC. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM AND THE BALLOON WAS REMOVED, THE STENT REMAINED IN PLACE AND A SMALLER BALLOON WAS USED TO INFLATE THE STENT. THE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495988 ↗
• MalfunctionMay 28, 2024Retraction Problem; Separation Failure; Difficult to Open or Remove Packaging Material; Retraction Problem; Separation Failure; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, DURING PREPARATION OF THE DEVICE, THE STENT SLEEVE ALLEGEDLY COULD NOT BE REMOVED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402932 ↗
• MalfunctionNov 14, 2023Difficult to Insert; Device Dislodged or Dislocated; Material Split, Cut or Torn; Difficult to Insert; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION, THERE WAS A RESISTANCE FELT UPON THE DEVICE WAS INSERTING INTO THE SHEATH AND THE EDGE OF THE STENT WAS ALLEGEDLY PEELED OFF. IT WAS FURTHER REPORTED THAT THE PHYSICIAN REPAIRED THE DEVICE AND ATTEMPTED TO RE-INSERT, BUT THE STENT WAS ALLEGEDLY DISLODGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129167 ↗
• MalfunctionAug 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THERE WAS STRONG RESISTANCE FELT UPON ADVANCING IN THE SHEATH AND THE STENT WAS ALLEGEDLY FOUND MISALIGNED. THE SYSTEM AND THE SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442006 ↗
• MalfunctionApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION, THE STENT ALMOST DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY WITHOUT DISLODGEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16774730 ↗
• MalfunctionMar 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA A RETROGRADE APPROACH IN THE COMMON ILIAC ARTERY, THE STENT ALLEGEDLY CAME OFF FROM THE DELIVERY SYSTEM. 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 13665386 ↗
• MalfunctionFeb 16, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AND DETACHED UPON DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE DETACHED BALLOON WAS RETRIEVED USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540849 ↗