Pivet G30457Recalls & reported problems
Cook Incorporated · Pivet Guide Embryo Transfer Catheter Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Medical Pivet Guide embryo transfer catheter set is used to move embryos into the uterus during IVF. The 29 reports mostly describe contamination found when opening the package — dirt, a hair, or other foreign matter inside the sealed inner packaging — along with one catheter that would not pass through the guide because of debris. No deaths and no injuries were reported, and in most cases a new set was used instead. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002304574), received between Dec 22, 2017 and Oct 22, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (9 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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem9
- Device Contaminated During Manufacture or Shipping8
- Contamination6
- Device Contamination with Chemical or Other Material5
- Complete Blockage1
- Difficult to Advance1
- Material Protrusion/Extrusion1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Patient Involvement6
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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
MAUDE report 23360456 ↗MalfunctionAug 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED; A HAIR WAS FOUND INSIDE THE OUTER CATHETER PACKAGING OF THE PIVET GUIDE EMBRYO TRANSFER SET. THE HAIR WAS FOUND PRIOR TO USE. THE USER REPLACED THE DEVICE WITH ANOTHER NEW DEVICE TO COMPLETE THE IVF-EMBRYO TRANSFER PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883035 ↗MalfunctionApr 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED, AFTER UNPACKING THE OUTER PACKAGING OF A PIVET GUIDE EMBRYO TRANSFER SET, THE USER FOUND THAT THE INNER PACKAGING OF THE PRODUCT WAS CONTAMINATED. IT WAS NOT USED AND WAS REPLACED WITH A NEW SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. A PHOTO OF WHAT APPEARS TO BE FOREIGN MATTER INSIDE THE SEALED PACKAGE WAS PROVIDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860295 ↗MalfunctionSep 27, 2024Contamination; Contamination
AS REPORTED, DURING AN IN VITRO FERTILISATION, EMBRYO TRANSFER PROCEDURE, IT WAS FOUND THAT THE INNER WALL OF THE UNUSED NEW PACKAGED PIVET GUIDE EMBRYO TRANSFER SET, HAD VISIBLE DIRT ON IT, AND THE CATHETER WAS SUSPECTED OF BEING CONTAMINATED. THE CATHETER WAS NOT USED AND REPLACED WITH A BRAND-NEW CATHETER. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20325516 ↗MalfunctionSep 10, 2024Complete Blockage; Contamination; Material Protrusion/Extrusion; Complete Blockage; Contamination; Material Protrusion/Extrusion
ADDITIONAL INFORMATION RECEIVED 08DEC2024: THE CATHETER DID COME INTO CONTACT WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20181824 ↗MalfunctionSep 6, 2024Contamination; Obstruction of Flow; Contamination; Obstruction of Flow
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20158213 ↗MalfunctionSep 6, 2024Contamination; Contamination
IT WAS REPORTED, UPON OPENING THE PIVET GUIDE EMBRYO TRANSFER SET'S PACKAGE A FOREIGN OBJECT WAS FOUND AT THE FRONT END OF THE INNER TUBE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20158019 ↗MalfunctionAug 11, 2023Difficult to Advance; Device Contaminated During Manufacture or Shipping; Difficult to Advance; Device Contaminated During Manufacture or Shipping
AS REPORTED, DURING AN EMBRYO TRANSFER USING A PIVET GUIDE EMBRYO TRANSFER SET, THE TRANSFER CATHETER COULD NOT BE PUSHED THROUGH THE GUIDE CATHETER DUE TO FOREIGN MATTER IN/ON THE DEVICE. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17512063 ↗MalfunctionAug 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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
MAUDE report 17501941 ↗MalfunctionMar 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PIVET GUIDE EMBRYO TRANSFER SET HAD IMPURITIES FOUND AT THE TIP OF THE INNER TUBE UNDER A MICROSCOPE. THIS WAS DISCOVERED AFTER THE EMBRYO WAS ABSORBED FROM THE PETRI DISH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639607 ↗MalfunctionDec 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO FOREIGN MATTER VISIBLE INSIDE THE DEVICE PRIOR TO FLUID ENTERING THE DEVICE. THE BUBBLES WERE NOTED IN THE ASPIRATED MEDIA AND NOT ON THE DEVICE SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15934157 ↗MalfunctionDec 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, DURING AN EMBRYO TRANSFER PROCEDURE, FOREIGN MATTER WAS FOUND INSIDE THE INNER CATHETER OF A PIVET GUIDE EMBRYO TRANSFER SET WHEN PREPARING TO LOAD THE DEVICE WITH EMBRYOS UNDER A MICROSCOPE. COOK BLASTOCYST CULTURE SOLUTION AND ANOTHER MANUFACTURER'S SYRINGE WERE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW DEVICE. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15934098 ↗MalfunctionDec 1, 2022Contamination; Contamination
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
MAUDE report 15893180 ↗MalfunctionDec 1, 2022Contamination; Contamination
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
MAUDE report 15893033 ↗MalfunctionOct 11, 2022Unsealed Device Packaging; Unsealed Device Packaging
UPON RETURN AND EVALUATION OF THE DEVICE, EVIDENCE OF A PACKAGE SEAL WAS PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15574858 ↗MalfunctionJun 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE INNER PACKAGE OF A PIVET GUIDE EMBRYO TRANSFER SET CONTAINED WATER DROPLETS. THE DROPLETS DISAPPEARED AFTER 24 HOURS. THE CUSTOMER SUSPECTED THE STERILE ENVIRONMENT OF THE PRODUCT HAD BEEN DAMAGED. THIS WAS NOTED PRIOR TO USE ON ANY PATIENTS. ALL THREE REPORTED AFFECTED DEVICES DISPLAYED THE SAME ISSUE. NO DAMAGE WAS NOTED ON ANY PACKAGING. THE CUSTOMER REPORTS THE DEVICES ARE STORED AS REQUIRED PER THE IFU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711382 ↗MalfunctionSep 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10567275 ↗MalfunctionSep 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10567228 ↗MalfunctionSep 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10567226 ↗MalfunctionSep 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10567068 ↗MalfunctionAug 7, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10379616 ↗MalfunctionFeb 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8377746 ↗MalfunctionJan 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8243860 ↗MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED, WHILE PREPPING FOR AN IN VITRO FERTILIZATION (IVF) PROCEDURE, PRIOR TO USING THE PIVET GUIDE EMBRYO TRANSFER SET, THE USER FOUND, UNDER A MICROSCOPE, THAT THERE WERE UNKNOWN FOREIGN FILAMENTS AT THE INNER CATHETER ORIFICE. ANOTHER SAME TYPE OF TRANSFER CATHETER WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7657890 ↗MalfunctionMar 27, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TWO PIVOT GUIDE EMBRYO TRANSFER SETS WERE OPENED AND OILY LIQUID WAS FOUND ON THE INNER CATHETER. AFTER FLUSHING THE SET, THE USER FOUND THE OILY LIQUID WAS ABSORBING INTO THE INNER WALL OF THE INNER CATHETER. THE DISTRIBUTOR IN CHINA IS RETURNING FIFTY SAME LOT DEVICES. 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 7374118 ↗
Other CATHETER, ASSISTED REPRODUCTION devices
- Guardia G34783Cook Incorporated · CATHETER, ASSISTED REPRODUCTION62 reports
- Guardia G53007Cook Incorporated · CATHETER, ASSISTED REPRODUCTION10 reports
- Soft-Pass G18955Cook Incorporated · CATHETER, ASSISTED REPRODUCTION8 reports
- Guardia G24216Cook Incorporated · CATHETER, ASSISTED REPRODUCTION5 reports
- Sydney IVF G18740Cook Incorporated · CATHETER, ASSISTED REPRODUCTION3 reports
- Soft-Pass G30399Cook Incorporated · CATHETER, ASSISTED REPRODUCTION2 reports
- Soft-Trans G26669Cook Incorporated · CATHETER, ASSISTED REPRODUCTION2 reports
- Soft-Pass G18658Cook Incorporated · CATHETER, ASSISTED REPRODUCTION2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page