Guardia G53007Recalls & reported problems
Cook Incorporated · Guardia AccessET Embryo Transfer Catheter · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002530072), received between Dec 1, 2014 and Sep 29, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 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
- Device Contaminated During Manufacture or Shipping5
- Contamination2
- Complete Blockage1
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- Nonstandard Device1
- Other (for use when an appropriate device code cannot be identified)1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Patient Involvement2
- Insufficient Information1
- Perforation1
Recent adverse event reports
The 10 most recent of 10 reports, 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 ↗MalfunctionSep 25, 2023Complete Blockage; Contamination; Complete Blockage; 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 17814134 ↗MalfunctionAug 18, 2023Nonstandard Device; Device Contaminated During Manufacture or Shipping; Nonstandard Device; 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17576720 ↗MalfunctionJul 13, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO DEVICE AVAILABLE FOR RETURN TO COOK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17320967 ↗MalfunctionSep 15, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF A GUARDIA ACCESSET EMBRYO TRANSFER CATHETER. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15426791 ↗MalfunctionApr 6, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, A HAIR WAS NOTED INSIDE THE PACKAGING OF A GUARDIA ACCESSET EMBRYO TRANSFER CATHETER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14024178 ↗MalfunctionNov 9, 2021Contamination; Contamination
ADDITIONAL INFORMATION WAS RECEIVED ON 16NOV2021: A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12779806 ↗MalfunctionDec 11, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, THE DISTRIBUTOR DISCOVERED A FOREIGN MATTER IN THE SEALED PACKAGING. SINCE THIS WAS DISCOVERED AT THE DISTRIBUTOR, THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 10993237 ↗MalfunctionDec 14, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Patient Involvement
MAUDE report 8164527 ↗MalfunctionDec 1, 2014Other (for use when an appropriate device code cannot be identified)
ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 19, 201 5 STATED THAT THE PATIENT DID NOT GET PREGNANT WITH THE LOST EMBRYO PATIENT WILL REPEAT FROZEN EMBRYO TRANSFER AT NATURAL CYCLE.
Patient problems: Perforation
MAUDE report 4322187 ↗
Other CATHETER, ASSISTED REPRODUCTION devices
- Guardia G34783Cook Incorporated · CATHETER, ASSISTED REPRODUCTION62 reports
- Pivet G30457Cook Incorporated · CATHETER, ASSISTED REPRODUCTION29 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.