LifeStream LSMU1350626Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05391522081055), received between Sep 28, 2017 and Jul 8, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Device Dislodged or Dislocated

  On (b)(6) 2026, a patient was prepped for a stent placement procedure using a Lifestream device. The reporter stated that they were not present during the case; information was provided by the technician. The vessel was predilated and adequately prepared prior to stent insertion. However, the stent was allegedly dislodged before deployment and was not used in the patient. There was no reported patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747479 ↗
• MalfunctionNov 24, 2025Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTREAM. DURING THE PROCEDURE, THE CATHETER COULD NOT BE ADVANCED TO THE APPROPRIATE DEPLOYMENT POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629038 ↗
• MalfunctionAug 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DETACHED FROM THE BALLOON WHILE TRYING TO PUT IT IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT DEPLOYMENT SYSTEM WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15247481 ↗
• MalfunctionJul 1, 2022Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE SHAFT WAS NOTED TO BE KINKED UPON REMOVAL FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883397 ↗
• MalfunctionOct 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT, THE STENT ALLEGEDLY DISLODGED OFF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704331 ↗
• MalfunctionJul 27, 2020Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY GOT STUCK AND WAS NOT ABLE TO LOAD THROUGH THE INTRODUCER SHEATH AND FAILED TO ADVANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325063 ↗
• MalfunctionJul 24, 2020Optical Decentration; Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated; Optical Decentration; Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE THROUGH THE CELIAC ARTERY, THE HEALTH CARE PROVIDER (HCP) IDENTIFIED UNDER FLUOROSCOPY THE COVERED STENT WAS TOO LONG, THEREFORE, THE DELIVERY SYSTEM WAS RETRACTED CAUSING THE STENT GRAFT TO ALLEGEDLY DISLODGED FROM THE BALLOON DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE HCP THEN MEASURED THE AREA WHERE THE STENT GRAFT HAD DISLODGED AND FOUND THE STENT GRAFT WAS NOT OCCLUDING ANY NECESSARY VESSEL. THEREFORE, THE STENT GRAFT WAS EXPANDED AND DEPLOYED IN PLACE. THE PROCEDURE WAS COMPLETED WITH THIS SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319494 ↗
• MalfunctionApr 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE HEALTHCARE PROVIDER (HCP) MADE MULTIPLE ATTEMPTS TO ADVANCE THE DELIVERY SYSTEM THROUGH THE TORTUOUS RENAL ARTERY, THE DELIVERY SYSTEM SUCCESSFULLY ARRIVED AT THE TARGET LESION AND DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS RETRIEVED. AIR EVACUATION WAS ALLEGEDLY NOT PERFORMED BEFORE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914359 ↗
• MalfunctionOct 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9221441 ↗
• MalfunctionNov 27, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF A BALLOON EXPANDABLE COVERED STENT, A HOLE WAS ALLEGEDLY IDENTIFIED ON THE STENT USING ANGIO. ANOTHER STENT WAS USED TO OVERLAP THE HOLE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109030 ↗
• MalfunctionNov 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, THE BALLOON EXPANDABLE VASCULAR STENT GRAFT ALLEGEDLY DISLODGED FROM THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8107222 ↗
• MalfunctionNov 3, 2017Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED INSIDE OF THE SHEATH. A 90 CM, 6FR, TERUMO DESTINATION SHEATH WAS USED. THE TARGET LESION WAS THE CORONARY ARTERY, CLOSE TO THE AORTIC ARCH. ACCESS WAS MADE VIA THE COMMON FEMORAL ARTERY. PRE DILATATION WAS PERFORMED. A LIFESTREAM DEVICE WAS DELIVERED TO THE DEPLOYMENT SITE, PASSING THROUGH THE ENTIRETY OF THE SHEATH. HOWEVER UPON INSPECTION, DR. FERNANDEZ JUDGED THAT THE STENT NEEDED TO BE PLACED IN A DIFFERENT POSITION, WHICH CALLED FOR A DIFFERENT SHEATH POSITION. THEREFORE, THE LIFESTREAM DEVICE UNIT WAS THEN WITHDRAWN OUT OF THE PATIENT FULLY INTACT. THE SHEATH WAS REPOSITIONED AND THE DEVICE WAS RE-DELIVERED. ONCE OUT OF THE DISTAL END OF THE SHEATH, IT WAS NOTED THE STENT-GRAFT WAS NO LONGER MOUNTED ON THE BALLOON. AN ANGIOGRAPHIC IMAGE SHOWED THE STENT GRAFT LODGED INSIDE THE DISTAL PORTION OF THE SHEATH. THE SHEATH WAS WITHDRAWN AND THE STENT WAS RETRIEVED. A SECOND SHEATH, THIS TIME A 6.5FR MEDTRONIC STEERABLE TOURGUIDE SHEATH WAS SELECTED AND PLACED. THE COMPLAINT DEVICE WAS TO BE USED. HOWEVER, AGAIN THE STENT-GRAFT WAS FOUND DISLODGED FROM THE BALLOON AND LODGED IN THE DISTAL PORTION OF THE SHEATH, CONFIRMED UNDER FLUOROSCOPY. T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998585 ↗
• MalfunctionSep 28, 2017Failure to Advance

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM WAS UNABLE TO BE ADVANCED THROUGH A COOK ANSEL 6F INTRODUCER SHEATH. THEREFORE THE DEVICE WAS PULLED OUT OF THE SHEATH. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH WAS REPLACED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900347 ↗