Sydney IVF G18740Recalls & reported problems
Cook Incorporated · Sydney IVF, Embryo Transfer Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002187405), received between Jun 24, 2019 and Jan 19, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem2
- Unsealed Device Packaging1
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2021Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Consequences Or Impact To Patient
MAUDE report 11197392 ↗MalfunctionJul 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT HAS BEEN REPORTED THAT PRIOR TO AN IN VITRO FERTILIZATION (IVF) PROCEDURE OF AN EMBRYO TRANSFER INTO THE UTERINE CAVITY OF A (B)(6) YEAR OLD FEMALE PATIENT USING A SYDNEY IVF MICROVOL EMBRYO TRANSFER CATHETER SET, THE HEALTHCARE PROFESSIONAL NOTED AN IMPURITY IN THE CATHETER. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE PATIENT AND EVENT. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8842415 ↗MalfunctionJun 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT IS REPORTED PRIOR TO AN IN VITRO FERTILIZATION(IVF)-EMBRYO TRANSFER PROCEDURE USING A SYDNEY IVF MICROVOL EMBRYO TRANSFER CATHETER SET, THE USER FOUND IMPURITY IN THE CATHETER. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8727910 ↗
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- Soft-Pass G18955Cook Incorporated · CATHETER, ASSISTED REPRODUCTION8 reports
- Guardia G24216Cook Incorporated · CATHETER, ASSISTED REPRODUCTION5 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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