SOLOPATH SR-2235Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852381004395), received between Oct 23, 2017 and May 11, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2018Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT DURING A TRANS CATHETER AORTIC VALVE IMPLANTATION (TAVI) THE SOLOPATH INTRODUCER WAS POSITIONED AND THE COREVALVE PRO AORTIC VALVE WAS IMPLANTED. IT WAS IMPOSSIBLE TO REMOVE THE DELIVERY OF THE INTRODUCER VALVE. DURING REMOVAL OF THE INTRODUCER AN AVULSION OF A PORTION OF THE RIGHT EXTERNAL ILIAC ARTERY OCCURRED. THE PATIENT UNDERWENT BYPASS SURGERY WITH A RIGHT FEMORAL ILIAC PROSTHESIS. ADDITIONAL INFORMATION WAS RECEIVED ON 5/3/2018: SOLOPATH WAS INSERTED AND INFLATED CORRECTLY BUT COREVALVESIC PRO WAS UNABLE TO PASS DUE TO A SPASM IN THE FEMORAL ARTERY. PHYSICIAN RETRIED TO DILATE THE SOLOPATH WITH ITS DILATOR AND ON THE SECOND ATTEMPT, THE VALVE CROSSED THE SOLOPATH EVEN WITH SOME FRICTION. AFTER A SUCCESSFUL VALVE DEPLOYMENT, THE DELIVERY SYSTEM OF COREVALVE PRO REMAINED STUCK IN THE SOLOPATH CANNULA DURING ITS RETRIEVAL AT THE END OF THE PROCEDURE. DUE TO THE IMPOSSIBILITY TO REMOVE THE COREVALVE DELIVERY SYSTEM FROM SOLOPATH, THE PHYSICIAN HAD TO REMOVE BOTH SYSTEMS (COREVALVE PRO DELIVERY SYSTEM + SOLOPATH) TOGETHER AS ONE PIECE. SOLOPATH WAS REMOVED SIMPLY BY PULLING IT OUT TOGETHER WITH COREVALVE PRO DELIVERY SYSTEM. AS A RESULT OF THE PULL

  Patient problems: Cephalohematoma; Perforation of Vessels

  MAUDE report 7508527 ↗
• InjuryOct 23, 2017Break; Deflation Problem; Break; Deflation Problem

  THE USER FACILITY REPORTED THEY WERE UNABLE TO DEFLATE THE BALLOON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) THE PHYSICIAN COULD NOT DEFLATE THE BALLOON; AND (2) THE COLLAPSE PORT WAS BROKEN WITHOUT ANY MANIPULATION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017. THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE BECAUSE HE COULD NOT DEFLATE THE BALLOON. THE PATIENT NEEDED 1 LITER OF BLOOD. A FEMORAL CROSS OVER BYPASS WAS REQUIRED. THE PATIENT WAS RATHER WEAK. THE TAVI WAS FINE, REGULAR WOUND HEALING PROCESS WAS DELAYED. NO OTHER DEVICES WERE USED WITH THE REPORTED PRODUCT.

  Patient problems: Blood Loss; Weakness

  MAUDE report 6968704 ↗