LifeStream LSMU0800626Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05391522081017), received between Aug 22, 2017 and Apr 28, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTREAM. WHILE DOING THE PROCEDURE, BALLOONS MOUNTED STENT CAME DISLODGED WHEN TRYING TO GO INTO SHEATH AND IT WAS SUCCESSFULLY RECOVERED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011598 ↗
• MalfunctionSep 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY VIA THE FEMORAL ARTERY, WHEN THEY TOOK THE PROTECTIVE COVERING OFF, THE STENT ALLEGEDLY CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297740 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE IN THE COMMON ILIAC VIA FEMORAL ARTERY, THE STENT GRAFT ALLEGEDLY CAME OFF WHEN THE PROTECTIVE 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 20277354 ↗
• MalfunctionJul 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT IN THE CELIAC ARTERY, THE STENT GRAFT ALLEGEDLY DISLODGED AS IT WAS BEING INSERTED INTO THE SHEATH. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256252 ↗
• MalfunctionJun 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DISTAL CALCIFIED LEFT CIA AT THE ANASTOMOSIS OF AN AORTA BI-ILIAC GRAFT VIA A RETROGRADE APPROACH ACCESS WITHOUT LESION PRE-DILATION, USING A 7X45 SHEATH AND AN GUIDEWIRE TO DELIVER THE BALLOON EXPANDABLE VASCULAR COVERED STENT GRAFT, THE STENT GRAFT WAS IDENTIFIED ALLEGEDLY DISLODGED ON THE WIRE PROXIMAL TO THE ANGIOPLASTY LOCATION, HOWEVER, IT WAS UNCLEAR AT WHAT POINT EXACTLY THE STENT GRAFT DISLODGED FROM THE BALLOON CATHETER. IT WAS FURTHER REPORTED THE 7FR SHEATH WAS EXCHANGED FOR AN 8X30 SHEATH, AND A 6FR GOOSE NECK SNARE WAS UTILIZED TO CAPTURE THE DISTAL TIP OF THE STENT AND RETRIEVED IT SUCCESSFULLY. REPORTEDLY, ANOTHER BALLOON EXPANDABLE VASCULAR COVERED STENT GRAFT WAS USED TO TREAT THE LOCATION AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7607038 ↗
• InjuryJan 18, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED INSIDE THE PATIENT. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE BOX, TRAY OR STENT COVER. THE TARGET LESION WAS THE SMA AND THE ACCESS WAS THROUGH THE CFA. THE PATIENT WAS BEING TREATED FOR STENOSIS AND OCCLUSION. REPORTEDLY, A COOK 6FR SHEATH AND AN AMPLAX 6W GUIDEWIRE WERE USED. THE STENT DISLOCATED WHILE ADVANCING THE DEVICE TO THE TARGET LESION. WHEN THE STENT DISLOCATED THE PHYSICIAN WAS ABLE TO DEPLOY THE PROXIMAL END OF THE STENT TO PREVENT IT FROM MIGRATING. THE DELIVERY SYSTEM WAS REMOVED THROUGH THE SHEATH. THE GUIDEWIRE WAS THEN CHANGED FOR A 0.014 SPARTACORE WIRE AND TWO ULTRAVERSE DEVICES WERE USED TO DILATE THE DISTAL END OF THE STENT. THE REST OF THE STENT WAS THEN DEPLOYED WITH ANOTHER ULTRAVERSE DEVICE. THE STENT WAS NOT DEPLOYED IN THE INTENDED TREATMENT SITE. PRE-DILATION WAS PERFORMED WITH AN ULTRAVERSE BALLOON. IT IS UNKNOWN IF THE STENT WAS PROTECTED BY THE SHEATH WHEN TRACKING TO THE LESION. IT IS UNKNOWN IF AIR EVACUATION WAS PERFORMED. MULTIPLE ATTEMPTS TO INSERT THE DEVICE INTO THE SHEATH WERE NOT REQUIRED. ANOTHER BALLOON EXPANDABLE VASCULAR COVERED STENT WAS REPORT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7203160 ↗
• MalfunctionDec 6, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED IN THE SHEATH. 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 WAS THE LEFT SUBCLAVIAN ARTERY. ACCESS WAS MADE VIA THE BRACHIAL ARTERY. A 260 ROSEN GUIDEWIRE AND A COOK 6F ANSEL INTRODUCER SHEATH WERE USED. THE PATIENT WAS BEING TREATED FOR 90% STENOSIS. DURING ADVANCEMENT INTO THE LESION, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON. REPORTEDLY, THE STENT REMAINED WITHIN THE 6FR SHEATH. THE DEVICE, STENT AND SHEATH WERE ALL REMOVED TOGETHER. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE PATIENT, GUIDEWIRE ACCESS WAS MAINTAIN, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE STENT WAS PROTECTED BY THE SHEATH DURING ALL STEPS OF TRACKING TOO THE LESION. MULTIPLE ATTEMPTS TO INSERT THE DEVICE INTO THE SHEATH WERE NOT MADE AND THE DEVICE WENT INTO THE SHEATH VALVE SMOOTHLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087475 ↗
• MalfunctionAug 22, 2017Difficult To Position

  IT WAS REPORTED THAT DURING TREATMENT, THE DEVICE WAS ALLEGEDLY DIFFICULT TO LOAD THROUGH A 6FR INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER MANAGED AND WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY, AND REMOVED THE DELIVERY SYSTEM WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810361 ↗