SOLOPATH STFI-1435Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852381004210), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2016Break; Break

  THE USER FACILITY REPORTED THAT THE SOLOPATH DEVICE BROKE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A 14FR X 35 CM SOLOPATH SHEATH WAS USED FOR AN EVAR PROCEDURE USING AN ENDOLOGIX GRAFT; THE PATIENT HAD 4 MM ILIAC VESSELS WITH HIGHLY CALCIFIED LESIONS AND PREVIOUSLY DEPLOYED STENTS PRESENT; THE VASCULAR SURGEON PRE-DILATED THE EXTERNAL AND COMMON ILIAC VESSELS WITH AN 8 MM FOLLOWED BY A 10 MM AND THEN A 12 MM BALLOON PRIOR TO PLACING THE SHEATH; THE SOLOPATH SHEATH WAS THEN INTRODUCED AND INFLATED WITHOUT INCIDENT; THE PROCEDURE WAS COMPLETED AND THE AAA GRAFT WAS PLACED SUCCESSFULLY; WHEN IT CAME TIME TO REMOVE THE SOLOPATH SHEATH, IT WOULD NOT MOVE; THE SURGEON PULLED VERY AGGRESSIVELY UNTIL THE SHEATH BROKE AROUND MID-SHAFT OF THE SHEATH, LEAVING THE DISTAL HALF IN THE VESSEL; THE SURGEON WAS ABLE TO REMOVE A FEW MORE SEGMENTS OF THE SHEATH VIA A CUT DOWN BUT WAS UNABLE TO REMOVE ALL THE REMAINING SEGMENTS; THE VASCULAR SURGEON LEFT THE REMAINING DISTAL PORTION OF THE SHEATH IN THE PATIENT AS IT WAS UNABLE TO BE RETRIEVED, THE SURGEON FELT IT DID NOT POSE A THREAT TO THE PATIENT'S HEALTH; BLOOD LOSS WAS LESS THAN 250

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 6176640 ↗