Soft-Pass G30399Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002303997), received between Jun 25, 2014 and Apr 3, 2019 — classified as 1 injury, 1 malfunction.

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

• MalfunctionApr 3, 2019Material Separation; Material Separation

  IT IS REPORTED WHILE PERFORMING A MEASUREMENT IN PREPARATION FOR EMBRYO TRANSFER USING AN EMBRYO TRANSFER CATHETER ASSIST DEVICE (RPNJ-SPPE-681710-ET-MC) THE ECHO TIP BAND BECAME CAUGHT IN THE OUTER CATHETER. PRIOR TO EMBRYO TRANSFER, THE PHYSICIAN REPORTS USING THE EMBRYO TRANSFER CATHETER ASSIST DEVICE (RPNJ-SPPE-681710-ET-MC) TO MEASURE WHERE THE EMBRYO WOULD BE PLACED. WHILE REMOVING THE CATHETER FROM THE OUTER SHEATH, THE PHYSICIAN REPORTED "THE ECHO TIP BAND BECAME CAUGHT IN THE OUTER CATHETER. A GREAT DEAL OF FORCE WAS REQUIRED TO SEPARATE THEM. METAL ECHO TIP DISLODGED FROM THE INNER CATHETER AND STUCK ONTO OUTER CATHETER " A SECOND SOFT-PASS ECHO TIP EMBRYO TRANSFER CATHETER SET (K-J-SPPE-681710-ET) WAS USED TO COMPLETE THE MEASUREMENT PRIOR TO EMBRYO TRANSFER WITHOUT DIFFICULTY. AFTER SUCCESSFUL MEASUREMENT, THE EMBRYO TRANSFER WAS COMPLETED USING A SOFT-PASS ECHO TIP EMBRYO TRANSFER CATHETER SET (K-J-SPPE-681710-ET). IT IS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480402 ↗
• InjuryJun 25, 2014Material Separation

  DURING A MOCK EMBRYO TRANSFER PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE INNER CATHETER AND IT GOT STUCK ON THE OUTER CATHETER. WHEN THE PHYSICIAN REMOVED THE SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER IT WAS NOTED THAT THE ECHO TIP BAND WAS NOT THERE. AN ULTRASOUND WAS DONE AND THE TIP WAS FOUND IN THE PATIENT. THE PATIENT HAD A SEPARATED BAND RETRIEVED VIA HYSTEROSCOPY ON (B)(6) 2014. IT WAS INDICATED THAT THEY HAD TO GO IN WITH A RIGID SCOPE TO REMOVE THE BAND AS IT WAS DIFFICULT TO RETRIEVE. THIS WAS THE SECOND IVF PROCEDURE FOR THE PATIENT. THERE WAS NO SHARP CERVICAL ANGLE. NO HARM WAS NOTED TO THE PATIENT.

  Patient problems: Foreign body, removal of

  MAUDE report 3918817 ↗