Destino Steerable Guiding Sheath DS127150GWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672001063), received between Feb 3, 2017 and Feb 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 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.

• MalfunctionFeb 3, 2017Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2014 THE CUSTOMER REPORTED "IN PATIENT #1, AT THE END OF THE CASE (WITH 2 INSERTIONS/RETRACTIONS OF THE ACM CATHETER) IT WAS NOTED THAT A SMALL RIBBON FIBER WAS PRESENT IN THE "BASKET" ARRAY AREA OF THE ACM CATHETER. THE FIBER WAS DISPOSED OF AT THE CLINICAL SITE. THE SHEATH USED IN THIS CASE WAS RETURNED TO ACUTUS MEDICAL FOR EVALUATION. THE SHEATH WAS INSPECTED ON THE OUTSIDE AND DISSECTED TO INSPECT THE INSIDE SURFACE. NO ANOMALIES WERE FOUND ON THE OUTSIDE SURFACES AND OBSERVATIONS WERE RECORDED REGARDING THE INNER SURFACE (PTFE LINER), SOME AREAS OF THE LINER APPEARED TO BE SCRATCHED AND/OR NOT PRESENT. SOME REGIONS OF THE LINER APPEAR TO HAVE FOLDS IN THE MATERIAL. THE SHEATH IN QUESTION WAS MODEL DS127150GW, L/N C8-01469. THIS WAS USED IN CONJUNCTION WITH AN ACM CATHETER. WE ARE SENDING BACK THE DISSECTED PARTS AND WILL AWAIT YOUR FINDINGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6301794 ↗