Soft-Pass G18955Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002189553), received between Jan 18, 2018 and Apr 21, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 8 most recent of 8 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 24940056 ↗
• InjuryMay 5, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11780657 ↗
• MalfunctionDec 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10942833 ↗
• MalfunctionFeb 26, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757593 ↗
• MalfunctionAug 1, 2018Material Separation; Material Separation

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7739617 ↗
• MalfunctionJul 5, 2018Bent; Material Separation; Bent; Material Separation

  IT WAS REPORTED, DURING A OOCYTE TRANSFER PROCEDURE AS THE SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET WAS ATTEMPTING TO ENTER THE CERVIX, THE CATHETER BENT. AS REPORTED, THE ECHO TIP CATHETER WENT AROUND IN THE CERVIX TWICE, AND WHEN THE SPECULUM WAS REMOVED, THEY NOTICED THE ECHO TIP IN THE VAGINA, THE ECHO TIP WAS REMOVED FROM THE VAGINA AND THEN THEY NOTICED THE TIP WAS MISSING ON THE CATHETER. AS REPORTED, THEY WAITED FOR A FULL BLADDER, THEN THEY USED A GYNETICS TULIP EMBRYO TRANSFER DEVICE WITHOUT COMPLICATIONS. THE DEVICE WAS DESTROYED AND WILL NOT BE RETURNED. PATIENT OUTCOME POST-PROCEDURE, NOT PREGNANT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663678 ↗
• MalfunctionApr 17, 2018Break; Break

  IT WAS REPORTED THAT THE METALLIC ECHO TIP FROM THE SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET HAS LOOSENED FROM THE TRANSFER CATHETER AND LAID AT THE BOTTOM OF THE PACKAGE. THE CATHETER WAS NOT USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7436644 ↗
• InjuryJan 18, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT ONE NORMAL FEMALE BLASTOCYST WAS THAWED IN PREPARATION FOR THE EMBRYO TRANSFER PROCEDURE. PRIOR TO THE EMBRYO TRANSFER PROCEDURE A TRIAL TRANSFER WAS PERFORMED USING THE COOK SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET. DURING THE TRIAL TRANSFER THE METAL OF THE ECHO-TIP SOFT-PASS EMBRYO TRANSFER CATHETER WAS NOTED TO BE MISSING AND THE TRANSABDOMINAL ULTRASOUND SHOWED A SMALL ECHOGENIC AREA WITHIN THE LOWER UTERINE SEGMENT CONSISTENT WITH THE METAL OF THE ECHO-TIP CATHETER. THE EMBRYO TRANSFER PROCEDURE WAS CANCELLED AND ON THE FOLLOWING DAY A HYSTEROSCOPIC REMOVAL OF THE METAL WAS SUCCESSFULLY DONE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME REGARDING THE PATIENT OR PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7203571 ↗