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Soft-Pass G18954Recalls & reported problems

Cook Incorporated · Soft-Pass EchoTip Embryo Transfer Catheter Set · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002189546), received between May 18, 2018 and May 18, 2018 — classified as 1 malfunction.

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

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2018Break; Break

    IT WAS REPORTED THAT DURING AN EMBRYO TRANSFER, THE SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET WAS USED. DURING EXTRACTION OF AN EMPTY CATHETER FROM THE PATIENT, THAT WAS INSERTED FOR A FIRST TRIAL, THE TIP OF THE TRANSFER CATHETER WAS STRUCK AND AS A RESULT THE METAL PART WAS DETACHED AND REMAINED IN THE PATIENT'S UTERUS. DURING THE EXTRACTION, THE CATHETER EXTENDED BEYOND ITS NORMAL LENGTH. THE DOCTOR DECIDED TO WAIT FOR THE PATIENT'S MENSTRUATION TO WASH IT OUT. NOW IT'S OUT OF THE PATIENT'S BODY. THE PATIENT WILL NEED TO COME IN FOR ANOTHER EMBRYO TRANSFER PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7526428 ↗

Other CATHETER, ASSISTED REPRODUCTION devices

All CATHETER, ASSISTED REPRODUCTION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.