Guardia G34783Recalls & reported problems
Cook Incorporated · Guardia Access Embryo Transfer Catheter · Class 2
All models of Guardia (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Guardia Access embryo transfer catheter is a thin tube used to move embryos into the uterus during fertility treatment. The 62 reports mostly describe contamination and packaging problems — opened or unsealed sterile packaging, dark granules or hair-like fibers found on or inside the package, and empty packages. No deaths and no injuries were reported, and in the described cases the procedure was finished with another device and patients had no effects. No recalls name 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
- 62
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00827002347830), received between Aug 4, 2017 and Jul 10, 2026 — classified as 62 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (21 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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping21
- Contamination /Decontamination Problem16
- Device Contamination with Chemical or Other Material13
- Contamination6
- Unsealed Device Packaging4
- Nonstandard Device2
- Packaging Problem2
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient21
- No Patient Involvement11
- No Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782740 ↗MalfunctionJun 29, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, THE GUARDIA ACCESS EMBRYO TRANSFER CATHETER'S PACKAGING WAS OPENED AND "THE SURFACE OF INTERNAL CATHETER WAS STAINED WITH A BLACK GRANULE". THE FACILITY CHANGED TO ANOTHER SAME-LIKE DEVICE TO FINISH THE EMBRYO TRANSFER PROCESS. 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 25652766 ↗MalfunctionMar 19, 2026Unsealed Device Packaging
IT WAS REPORTED, THE PACKAGE OF A GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER WAS FOUND UNSEALED. THERE WAS NO PRODUCT INSIDE THE PACKAGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 24638099 ↗MalfunctionDec 23, 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 23877369 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS FOUND INSIDE THE STERILE PACKAGING OF A GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER. THE FIBER BECAME VISIBLE FROM BEHIND THE LABELING WHEN BEING HANDLED BY THE DISTRIBUTOR. THE COMPLAINT DEVICE REMAINED WITH THE DISTRIBUTOR AND NEVER MADE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657176 ↗MalfunctionSep 12, 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 23038470 ↗MalfunctionJul 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 22563904 ↗MalfunctionOct 25, 2024Device 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 20533628 ↗MalfunctionSep 23, 2024Contamination; Device Contaminated During Manufacture or Shipping; Contamination; 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 20284199 ↗MalfunctionAug 7, 2024Packaging Problem; Packaging Problem
AS REPORTED, WHEN UNPACKING THE GUARDIA ACCESS EMBRYO TRANSFER CATHETER, THE INNER CATHETER PACKAGING WAS FOUND DAMAGED PRIOR TO AN EMBRYO TRANSFER PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929199 ↗MalfunctionJul 24, 2024Device 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 19822069 ↗MalfunctionJul 11, 2024Device 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 19724468 ↗MalfunctionJun 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE PACKAGING OF AN GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER WAS FOUND TO CONTAIN SMALL HAIRS. IT WAS REPORTED THERE WERE NO ADVERSE EFFECTS DUE TO THIS OCCURRENCE AS THE DEVICE DID NOT MAKE PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19446318 ↗MalfunctionMay 10, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER HAD FOREIGN MATERIAL IN THE PACKAGE WHEN THE DEVICE ARRIVED TO THE DISTRIBUTOR. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19285156 ↗MalfunctionMar 20, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, DIRT WAS FOUND IN THE PACKAGING OF A GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER. THE DEVICE DID NOT MAKE PATIENT CONTACT AND WAS FOUND DURING THE PROCESS OF RECEIVING AND CHECKING PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18943525 ↗MalfunctionJan 25, 2024Device 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 18584440 ↗MalfunctionDec 15, 2023Contamination; 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 18336123 ↗MalfunctionOct 17, 2023Contamination; Contamination
IT WAS REPORTED THAT THE INTERNAL WALL OF A 'GUARDIA ACCESS EMBRYO TRANSFER CATHETER' APPEARED "DIRTY" WHEN OBSERVED THROUGH THE MICROSCOPE PRIOR TO AN EMBRYO TRANSFER. NO PICTURES ARE AVAILABLE FROM THE CUSTOMER FOR COOK TO REVIEW. NO FLUID HAD YET BEEN INTRODUCED INTO THE DEVICE. THE DEVICE WAS NOT USED AND A NEW TRANSFER CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 17951489 ↗MalfunctionSep 14, 2023Complete Blockage; Infusion or Flow Problem; Device Contaminated During Manufacture or Shipping; Complete Blockage; Infusion or Flow Problem; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE DOCTOR TRIED TO LOAD THE FRESH EMBRYOS INSIDE THE INNER CATHETER OF THE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER, BUT THERE WAS NO SUCTION. ANOTHER NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE TRANSFER WAS SUCCESSFUL, AS THE PATIENT RECEIVED A POSITIVE PREGNANCY TEST. IT WAS NOTED THAT THE CATHETER WAS NOT FLUSHED PRIOR TO USE. NO BUBBLES WERE SEEN IN THE TRANSFER CATHETER OR FLUSHING MEDIA. THE MEDIA COLUMN DID NOT BREAK. TWO EMBRYOS WERE TRANSFERRED WITH THIS CATHETER. THE DEVICE WAS STORED IN A DARK PLACE, 22OC. UPON DEVICE RETURN TO THE MANUFACTURER, IT WAS FOUND THERE WAS AN OCCLUSION IN THE TUBING. THE OCCLUSION SUBSTANCE APPEARS TO BE DARK GOLDISH BROWN IN COLOR AND IS BELIEVED TO BE FOREIGN MATTER. THE OCCLUSION COULD NOT BE DISLODGED BY EITHER SIDE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745406 ↗MalfunctionJul 21, 2023Nonstandard Device; Nonstandard Device
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 17372848 ↗MalfunctionMay 25, 2023Unsealed 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 17003763 ↗MalfunctionOct 20, 2021Contamination; Contamination
AS REPORTED, WHILE ATTEMPTING TO USE A GUARDIA ACCESS EMBRYO TRANSFER CATHETER, FOREIGN MATTER WAS NOTED IN THE TRANSFER CATHETER AND WAS UNABLE TO PASS THROUGH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12664605 ↗MalfunctionSep 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, PRIOR TO USE DURING AN EMBRYO TRANSFER, A STAIN DESCRIBED AS BLACK SPOTS WAS NOTED INSIDE THE TIP OF A GUARDIA ACCESS EMBRYO TRANSFER CATHETER. NO FLUID HAD ENTERED THE CATHETER AT THE TIME THE STAIN WAS NOTICED. ANOTHER DEVICE WAS USED TO COMPLETE THE DIFFICULT PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12463974 ↗MalfunctionAug 25, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IN OUR INITIAL REPORT WE INCORRECTLY REPORTED THAT TEN GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETERS IN THE LOT CONTAINED THE OILY SUBSTANCE. TEN UNUSED UNOPENED DEVICE FROM THE LOT ARE BEING RETURNED. ADDITIONAL INFORMATION WAS RECEIVED 15SEP2021: THE OILY SUBSTANCE WAS NOTICED PRIOR TO ANY LIQUID ENTERING THE DEVICES. APPROXIMATELY TWENTY DEVICES WERE OPENED AND NOTED TO HAVE AN OILY SUBSTANCE ON THE INNER WALL OF THE TRANSFER CATHETER. SPECIFIC DETAILS ON THE NUMBER OF CASES, DATE OF EVENTS, PATIENT DEMOGRAPHICS IS NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12364954 ↗MalfunctionJul 12, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12149112 ↗
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- 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 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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