LifeStream LSMU0800938Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05391522081246), received between Dec 11, 2019 and Feb 11, 2026 — classified as 4 injuries, 12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTREAM DEVICE. AFTER THE GUIDEWIRE SUCCESSFULLY CROSSED THE LESION, THE DESIGNATED STENT WAS PREPARED FOR USE. HOWEVER, THE STENT BECAME DISLODGED DURING DELIVERY. THE DISLODGED STENT WAS SUBSEQUENTLY RETRIEVED WITHOUT LEAVING ANY RESIDUAL MATERIAL IN THE PATIENT'S BODY. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATIVE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312837 ↗
• InjuryAug 29, 2025Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM CTO LESION VIA RADIAL APPROACH. IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, ANTEGRADE WIRING WAS ATTEMPTED, BUT DID NOT PASS THROUGH THE LESION. AFTER SOMEHOW PASSING THE LESION WITH A 14 WIRE, A PREBALLOON WAS PERFORMED WITH A 5MM PTA BALLOON. WHEN CONFIRMED WITH IVUS, VASCULAR DISSECTION HAD OCCURRED. THEN IT WAS DECIDED TO SEAL THE ENTRY. IVUS CONFIRMED THAT THE DISSECTION HAD BEEN COMPLETELY SEALED. FINAL ANGIOGRAPHY SHOWED GOOD BLOOD FLOW, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Vascular Dissection

  MAUDE report 22920285 ↗
• MalfunctionAug 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM, THE STENT COULD NOT ADVANCE THROUGH THE SHEATH AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804076 ↗
• MalfunctionJan 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC AND EXTERNAL ILIAC ARTERIES VIA THE LEFT INGUINAL ACCESS, THE BALLOON MARKER WAS ALLEGEDLY FOUND TO BE DISPLACED. IT WAS FURTHER REPORTED THAT WHEN AN ATTEMPT WAS MADE TO REPLACE IT, THE STENT FELL OUT, BUT IT WAS MOVED TO THE LESION AND LEFT IN PLACE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21051380 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY SHIFTED SIGNIFICANTLY WHEN REMOVING THE STENT COVER, AFTER OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445120 ↗
• MalfunctionFeb 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE VIA COMMON FEMORAL ARTERY BILATERALLY, DIFFICULT TO PASS GUIDEWIRE BUT CROSSED AND OVER SHEATHED WITH SHEATH WITH BILATERAL KISSING. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DROPPED OUT DURING POSITIONING AND LESION WAS NOT COVERED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738600 ↗
• MalfunctionNov 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 12 ATM WHEN ATTEMPTED TO DILATE IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18063554 ↗
• MalfunctionDec 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE OF A CALCIFIED AND CHRONIC TOTAL OCCLUSION IN THE LEFT COMMON ILIAC ARTERY, THE BALLOON ALLEGEDLY RUPTURED AT THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16031669 ↗
• MalfunctionSep 12, 2022Difficult to Open or Remove Packaging Material; Material Split, Cut or Torn; Difficult to Open or Remove Packaging Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FELT RESISTANCE UPON REMOVING THE STENT COVER. IT WAS FURTHER REPORTED THAT THE OUTER STENT WAS ALLEGEDLY PEELED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15398842 ↗
• MalfunctionAug 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THE COVERED STENT WAS ALLEGEDLY MISALIGNED AS THE DEVICE WAS INSERTED. 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 15264351 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE EXTERNAL ILIAC AND AFTER USING A MYNX CLOSURE DEVICE, THE BLOOD PRESSURE OF THE PATIENT ALLEGEDLY STARTED TO DROP ULTIMATELY LEADING TO THE DEATH OF THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension

  MAUDE report 12622391 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE EXTERNAL ILIAC AND AFTER USING A MYNX CLOSURE DEVICE, THE BLOOD PRESSURE OF THE PATIENT ALLEGEDLY STARTED TO DROP ULTIMATELY LEADING TO THE DEATH OF THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 12622317 ↗
• MalfunctionJul 2, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING LIFE-STREAM PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILURE TO INSERT THROUGH 7FR ANSEL SHEATH. IT WAS FURTHER REPORTED THAT IT FELL OFF THE CATHETER WHILE TRYING TO PASS THROUGH THE HEMOSTASIS VALVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223951 ↗
• InjuryMar 25, 2020Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION FOR A KISSING STENT GRAFT PLACEMENT IN THE MODERATELY CALCIFIED COMMON ILIAC VIA FEMORAL TRACKING, AIR BUBBLES WERE ALLEGEDLY IDENTIFIED; HOWEVER, THE HEALTHCARE PROVIDER (HCP) CONTINUED WITH THE PROCEDURE. DURING TREATMENT, A RUPTURE WAS ALLEGEDLY IDENTIFIED, PREVENTING FULL STENT GRAFT EXPANSION. AS A RESULT, THE HCP BEGAN TO REMOVE THE DELIVERY SYSTEM AND THE STENT GRAFT DISLODGED FROM THE BALLOON. REPORTEDLY, AN ADDITIONAL PTA BALLOON WAS USED TO RETRACT THE DISLODGED STENT GRAFT INTO THE COMMON FEMORAL ARTERY AND A SURGICAL CUTDOWN PROCEDURE WAS REQUIRED TO RETRIEVE THE STENT GRAFT ALTOGETHER. ANOTHER STENT OF A DIFFERENT MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Injury

  MAUDE report 9880960 ↗
• MalfunctionFeb 20, 2020Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT, THE DELIVERY SYSTEM FAILED TO ADVANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733268 ↗
• MalfunctionDec 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE BALLOON EXPANDABLE VASCULAR COVERED STENT WAS INFLATED TO 10 ATM AND THE STENT ALLEGEDLY EXPANDED ON ONE SIDE WHICH ALLEGEDLY CAUSED A LONGITUDINAL SPLIT IN THE PTFE. THEREFORE, THE DEVICE WAS REMOVED AND DEPLOYED OUTSIDE OF THE PATIENT AS A DEMONSTRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451422 ↗