SOLOPATH SR-2435Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852381004418), received between May 19, 2016 and May 23, 2018 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A TEVAR CASE WITH LEFT CFA ACCESS USING SOLOPATH DEVICE THE PHYSICIAN ATTEMPTED TO INFLATE THE DEFLATION BALLOON AND ALL OF THE CONTRAST WAS NOTED TO BE LEAKING FROM A HOLE IN THE EXTERNAL SOLOPATH BALLOON. THE PHYSICIAN FORCED A RAPID BOLUS OF CONTRAST WHICH WAS ABLE TO GET PRESSURE TO 6ATM WHICH DID COLLAPSE THE SOLOPATH BEFORE REMOVAL. IT WAS ALSO NOTED THAT AFTER THE DILATOR WAS REMOVED FROM THE SOLOPATH AND A WIRE WAS IN PLACE, THE SOLOPATH LEAKED BLOOD, AT TIMES BEING A PULSATILE STREAM. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PATIENT IS FINE AND STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7537572 ↗
• MalfunctionMay 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT DURING A TEVAR CASE WITH LEFT CFA ACCESS USING SOLOPATH DEVICE THE PHYSICIAN ATTEMPTED TO INFLATE THE DEFLATION BALLOON AND ALL OF THE CONTRAST WAS NOTED TO BE LEAKING FROM A HOLE IN THE EXTERNAL SOLOPATH BALLOON. THE PHYSICIAN FORCED A RAPID BOLUS OF CONTRAST WHICH WAS ABLE TO GET PRESSURE TO 6ATM WHICH DID COLLAPSE THE SOLOPATH BEFORE REMOVAL. IT WAS ALSO NOTED THAT AFTER THE DILATOR WAS REMOVED FROM THE SOLOPATH AND A WIRE WAS IN PLACE, THE SOLOPATH LEAKED BLOOD, AT TIMES BEING A PULSATILE STREAM. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PATIENT IS FINE AND STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7537006 ↗
• InjuryMay 19, 2016Break; Break

  THE USER FACILITY REPORTED SHEATH SEPARATION WHILE USING THE SOLOPATH DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: ILIAC AVULSION ON SOLOPATH RE-COLLAPSIBLE SHEATH; THE VESSEL WAS ACCESSED VIA FEMORAL ARTERY CUT DOWN ON THE RIGHT SIDE FOR THE PURPOSE OF INTRODUCING A 37MM GORE TAG GRAFT FOR A TYPE B DISSECTION; ACCESS WAS GAINED AND A 35CM 24FR. SOLOPATH SHEATH WAS INTRODUCED OVER A LUNDERQUIST WIRE INTO THE AORTA; DURING INSERTION SOME RESISTANCE WAS ENCOUNTERED, MOST LIKELY AS A RESULT OF CALCIUM IN THE ARTERY; THE SHEATH WAS TWISTED, RE-POSITIONED AND WAS ADVANCED OVER THE WIRE INTO THE DESCENDING AORTA; THE SOLOPATH WAS INFLATED PER IFU AND THE TAG GRAFT WAS DELIVERED SUCCESSFULLY; WHEN IT WAS TIME TO REMOVE THE SOLOPATH RC SHEATH, A WIRE WAS INSERTED INTO THE ASCENDING AORTA AND AN ENDOFLATOR WAS ATTACHED TO THE SIDE ARM COLLAPSIBLE PORT TO INFLATE THE OUTER BALLOON FOR COLLAPSING; PER THE IFU, THE PHYSICIAN TRIED TO INFLATE THE OUTER BALLOON TO 6ATM TO COLLAPSE THE SHEATH, HOWEVER, 4ATM WAS THE MAXIMUM INFLATION ACHIEVED, LIKELY BECAUSE OF A "PINHOLE" IN THE OUTER BALLOON CAUSED BY CALCIUM; THE PHYSICIAN DECIDE

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

  MAUDE report 5667713 ↗