GuardiaRecalls & reported problems across all models
Cook Incorporated · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Guardia by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2014 and Sep 29, 2026 — classified as 78 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Guardia problems
Device problems
- Device Contaminated During Manufacture or Shipping30
- Contamination /Decontamination Problem18
- Device Contamination with Chemical or Other Material14
- Contamination8
- Unsealed Device Packaging4
- Nonstandard Device3
- Packaging Problem3
- Complete Blockage2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient22
- No Patient Involvement15
- No Information2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Perforation1
Guardia models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Guardia G34783CATHETER, ASSISTED REPRODUCTION62 reports
- Guardia G53007CATHETER, ASSISTED REPRODUCTION10 reports
- Guardia G24216CATHETER, ASSISTED REPRODUCTION5 reports
- Guardia G34784CATHETER, ASSISTED REPRODUCTION1 report
Recent Guardia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938618 ↗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 ↗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 ↗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 ↗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 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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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