Soft-Pass G18658Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002186583), received between Apr 23, 2018 and Apr 21, 2026 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 21, 2026Device Contaminated During Manufacture or Shipping

  AS REPORTED, FOREIGN MATTER RESEMBLING A FIBER WAS NOTED ON THE "RIGHT SIDE OF THE TIP AND THE ECHO METAL" OF A SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET DURING A FROZEN EMBRYO TRANSFER (FET) PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAS BEEN NO REPORT OF THE PATIENT EXPERIENCING ADVERSE EFFECTS. HOWEVER, THE USER EXPRESSED CONCERN ABOUT THE POTENTIAL IMPACT ON EMBRYO IMPLANTATION RESULTS. THE USER IS WAITING FOR THE PATIENT'S RESULTS WHICH SHOULD BE APPROXIMATELY NINE DAYS AFTER THE PROCEDURES WERE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940112 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT AT THE TIME OF MAKING AN EMBRYO TRANSFER, THE ECHOTIP FROM THE SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET HAD DETACHED AND WAS LEFT INSIDE THE PATIENT. THE ECHOTIP FROM THE CATHETER WAS NOT RETRIEVED. THE DOCTOR STATED THAT THE CATHETER HAD BEEN REUSED BY HIS ASSISTANT. PER THE INSTRUCTIONS FOR USE (IFU) THE DEVICE IS INTENDED FOR ONE-TIME USE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7451936 ↗