DASH G57298Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002572987), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionSep 5, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H.® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. IT WAS INITIALLY REPORTED THAT THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE DOWN AS SOON AS THE NURSE TRIED TO BAND IT IN FRONT OF THE PAPILLA SO THEY TOOK ANOTHER ONE OF THE SAME DEVICES. THE DEVICE WAS RETURNED FOR EVALUATION ON (B)(6) 2025. THIS COMPLAINT WAS ORIGINALLY INTERPRETED AS CUTTING WIRE BREAKS IN ONE LOCATION W/O DETACHMENT WHICH HAS NOT HISTORICALLY BEEN CONSIDERED A REPORTABLE EVENT FOR THE US. HOWEVER, THE RETURNED DEVICE WAS FOUND TO HAVE ANCHOR SEPARATION WITHOUT DETACHMENT. [SUBJECT OF REPORT] A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978283 ↗