Soft-Trans G26669Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002266698), received between Aug 10, 2017 and Aug 22, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

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.

• MalfunctionAug 22, 2017Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material; Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material

  THE COOK REPRESENTATIVE VISITED THE USER FACILITY TO PERFORM TESTING OF UNUSED SOFT-TRANS EMBRYO TRANSFER CATHETERS IN STOCK AT THE FACILITY IN AN EFFORT TO FIND A CATHETER THAT FLUSHES OUT YELLOW MEDIA FLUID. AFTER TESTING OVER 50 UNUSED CATHETERS, ONE CATHETER WAS FINALLY FOUND THAT THE MEDIA WAS FLUSHED THROUGH THE CATHETER AND CAME OUT YELLOW. THIS SAMPLE AND THE OTHER DEVICES USED DURING THE TEST WERE PACKAGED TOGETHER TO RETURN TO THE MANUFACTURER FOR FURTHER ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT DURING THIS TESTING. THE ISSUE OF MEDIA FLUID FLUSHING OUT "YELLOW" WAS PREVIOUSLY REPORTED BY THIS FACILITY. HOWEVER, SAMPLES WERE NOT PROVIDED FOR ANALYSIS. THE TWO PREVIOUS REPORTS CAN BE FOUND IN MFR. REPORT NUMBERS 1820334-2017-02298 AND 1820334-2017-02304.

  Patient problems: No Patient Involvement

  MAUDE report 6811082 ↗
• MalfunctionAug 10, 2017Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material; Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED PRIOR TO ALL EMBRYO TRANSFERS THE CATHETERS ARE FLUSHED USING CLEAR VITROLIFE MEDIA. DURING THE LAST EMBRYO TRANSFER OF THE DAY, THE SOFT-TRANS EMBRYO TRANSFER CATHETER WAS FLUSHED WITH MEDIA BUT THE FLUID CAME OUT YELLOW. THE CATHETER WAS NOT USED. ALL REMAINING MEDIA FROM THE SAME LOT WAS CHECKED AND NO SIGN OF DISCOLORATION WAS FOUND. A NEW CATHETER WAS FLUSHED WITH A FRESH TUBE OF MEDIA AND THE LIQUID CAME OUT CLEAR. THE NEW CATHETER WAS USED FOR THE EMBRYO TRANSFER. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE YELLOW EXPELLED LIQUID WAS VIEWED UNDER THE MICROSCOPE. NO SIGN OF GROWTH WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6785574 ↗