Guardia G24216Recalls & reported problems
Cook Incorporated · Guardia Access Nano Embryo Transfer Catheter · Class 2
All models of Guardia (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002242166), received between Oct 30, 2019 and Sep 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 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 Shipping3
- Contamination /Decontamination Problem1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 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 23009081 ↗MalfunctionDec 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PACKAGING OF THE 'GUARDIA ACCESS NANO EMBRYO TRANSFER CATHETER' WAS FOUND TO BE CONTAMINATED DURING AN UNSPECIFIED PROCEDURE. THE USER OF THE DEVICE FOUND A HAIR PARTICLE INSIDE THE STERILE PACKAGING AND REFUSED TO USE THE PRODUCT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER TRANSFER CATHETER. AS REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902169 ↗MalfunctionOct 22, 2021Packaging Problem; Packaging Problem
ADDITIONAL INFORMATION WAS PROVIDED ON 29OCT2021: THE "FIBER" LOOKS LIKE FOREIGN MATTER IN THE CATHETER. IT WAS NOTED TO BE 2/3 WITHIN THE CATHETER AND 1/3 OUTSIDE OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW DEVICE. THERE WERE NO ADVERSE EFFECTS REPORTED. THE "FIBER" WILL BE RETURNED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681700 ↗MalfunctionDec 4, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED, DURING INCOMING QUALITY INSPECTION OF A GUARDIA ACCESS NANO EMBRYO TRANSFER CATHETER AT ONE OF COOK'S DISTRIBUTORS, A FOREIGN MATTER WAS FOUND IN THE SEALED PACKAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10948638 ↗MalfunctionOct 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9256561 ↗
Other CATHETER, ASSISTED REPRODUCTION devices
- Guardia G34783Cook Incorporated · CATHETER, ASSISTED REPRODUCTION62 reports
- Pivet G30457Cook Incorporated · CATHETER, ASSISTED REPRODUCTION29 reports
- Guardia G53007Cook Incorporated · CATHETER, ASSISTED REPRODUCTION10 reports
- Soft-Pass G18955Cook Incorporated · CATHETER, ASSISTED REPRODUCTION8 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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