LifeStream LSMU0800726Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05391522081093), received between Dec 20, 2017 and Aug 5, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Device Dislodged or Dislocated; Material Deformation

  On (b)(6) 2026, a patient underwent a stent placement procedure using a Life stream device. During the procedure, it was reported that the stent detached from the delivery system and required retrieval using a snare. The detachment was noted after the stent delivery system had been positioned at the intended treatment site within the subclavian artery. Angiography was performed to confirm device position prior to deployment, at which time it was observed that the stent was no longer mounted on the delivery shaft. The stent was subsequently located in the brachial artery. The procedure was prolonged and was subsequently completed using another device. The patient's current condition was unknown.

  Patient problems: Foreign Body In Patient

  MAUDE report 50144024 ↗
• MalfunctionJul 20, 2026Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25870392 ↗
• MalfunctionJun 18, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A BALLOON EXPANDABLE STENT GRAFT USING THE LIFESTREAM DEVICE. DURING THE PROCEDURE, THE INITIALLY INTENDED STENT WAS DISLODGED DURING PLACEMENT DUE TO INTERFERENCE AND WAS FAILED TO COVER THE LESION, NECESSITATING PLACEMENT OF AN ADDITIONAL STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547036 ↗
• InjuryJun 9, 2026Device Dislodged or Dislocated

  A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTREAM. IT WAS REPORTED THAT DELIVERY WAS ATTEMPTED VIA THE CONTRALATERAL APPROACH. HOWEVER, THE STENT DISLODGED JUST PROXIMAL TO THE CONTRALATERAL LESION. THE STENT REMAINED IMPLANTED WITHIN THE BODY, THE DELIVERY SYSTEM WAS WITHDRAWN THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 25442438 ↗
• MalfunctionApr 24, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM. THE STENT FELL OFF THE SHAFT DURING DEPLOYMENT IN THE SHEATH TARGETING THE SMA VESSEL. THE LIFESTREAM WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979528 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON BEFORE BEING DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884729 ↗
• MalfunctionApr 16, 2025Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND TO THE PRESCRIBED VALUE AND WAS SLIGHTLY FLOATING. FURTHER IT WAS REPORTED THAT BALLOON DISLODGEMENT OBSERVED IN THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851497 ↗
• MalfunctionOct 24, 2024Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY WOULD NOT CROSS. IT WAS FURTHER REPORTED THAT THE TIP WAS ALLEGEDLY BEND. REPORTEDLY, STENT ALLEGEDLY DISLODGED FROM DEPLOYMENT BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520882 ↗
• MalfunctionOct 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE PROTECTOR AND THE STENT ALLEGEDLY FELL OFF TOGETHER FROM THE MOUNTING BALLOON WHILE THE PROTECTIVE COVER WAS BEING REMOVED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437099 ↗
• MalfunctionSep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT PROCEDURE VIA IPSILATERAL APPROACH, THE STENT AND TIP OF THE SHEATH INTERFERED AND ALLEGEDLY FELL OUT CENTRALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244546 ↗
• MalfunctionMay 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA BILATERAL FEMORAL ARTERY APPROACH, THE DEVICE ALLEGEDLY FAILED TO PASS THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403239 ↗
• MalfunctionMay 3, 2024Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY COULD NOT BE INSERTED INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY FELL OUT OF 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 19238862 ↗
• MalfunctionFeb 20, 2024Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE SHEATH, IT ALLEGEDLY GOT CAUGHT AND WAS DIFFICULT TO BE INSERTED IT INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS ALLEGEDLY DISLODGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738368 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN A BILATERAL FEMORAL ARTERY APPROACH, THE DEVICE ALLEGEDLY COULD NOT PASS THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473029 ↗
• MalfunctionSep 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE USING A SIX-FRENCH SHEATH, THE STENT WAS ALLEGEDLY MISALIGNED FROM THE SHAFT OF THE CATHETER AND FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17676073 ↗
• MalfunctionJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT WAS ALLEGEDLY DISLODGED FROM THE BALLOON WHEN THE COVERED STENT GUARD WAS REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296568 ↗
• MalfunctionJun 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE OF CHRONIC TOTAL OCCLUSION IN THE COMMON ILIAC ARTERY AND EXTERNAL ILIAC ARTERY VIA AN IPSILATERAL APPROACH FROM COMMON FEMORAL ARTERY, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM UPON DELIVERING. THE DISLODGED STENT WAS RETRIEVED WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITHOUT USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196164 ↗
• MalfunctionJun 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY BELOW THE BIFURCATION SITE VIA A RETROGRADE APPROACH THROUGH THE COMMON FEMORAL ARTERY, THE BALLOON ALLEGEDLY FAILED TO INFLATE. 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 17164914 ↗
• MalfunctionJan 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE IN THE EXTERNAL ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THE STENT ALLEGEDLY DISLODGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143316 ↗
• MalfunctionDec 27, 2021Inflation Problem; Separation Failure; Device Dislodged or Dislocated; Inflation Problem; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED FORM BALLOON BEFORE DEPLOYMENT. IT WAS FURTHER REPORTED THAT STENT GRAFT WAS RETRIEVED VIA A SNARE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087826 ↗
• MalfunctionDec 7, 2021Migration or Expulsion of Device; Device-Device Incompatibility; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY FAILED TO BE INSERTED THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY MIGRATED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958249 ↗
• MalfunctionOct 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES USING 6FR SHEATH, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE INSERTED THROUGH THE SHEATH. 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 12631245 ↗
• MalfunctionJun 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING BALLOON EXPANDABLE STENT DEPLOYMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INSERT DEVICE THROUGH THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10211190 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FIRST TIME INTERVENTION VIA AN IPSILATERAL RIGHT COMMON FEMORAL APPROACH TO TREAT A VERY CALCIFIED ILIAC LESION FOR A PATIENT WITH ABNORMAL BRACHIAL INDEX (ABI), THE BALLOON EXPANDABLE VASCULAR COVERED STENT CATHETER ALLEGEDLY FAILED TO LOAD THROUGH A 6FR INTRODUCER SHEATH. THEREFORE, THE CATHETER WAS REMOVED WITHOUT INCIDENT FROM THE PATIENT, AND A 6X37 BALLOON EXPANDABLE VASCULAR COVERED STENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672145 ↗
• MalfunctionJun 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PREPARATION, THE BALLOON EXPANDABLE VASCULAR COVERED STENT CATHETER WAS ALLEGEDLY UNABLE TO PASS THROUGH THE 6FR INTRODUCER SHEATH. ANOTHER BALLOON EXPANDABLE VASCULAR COVERED STENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7640039 ↗