Cook G04324Recalls & reported problems
Cook Incorporated · Fallopian Tube Catheterization Set · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002043244), received between Jul 16, 2020 and Aug 26, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, RUST WAS FOUND WITHIN THE PACKAGING ON A FALLOPIAN TUBE CATHETERIZATION SET. THE PACKAGING WAS NOT DAMAGED, AND THE SEAL WAS INTACT. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15302790 ↗MalfunctionJul 16, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10283539 ↗
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- Mckesson 11-19611Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter with Integrated Stylet 61-4005SCoopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter • 5 French 61-4005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Catheter with Integrated Stylet • 5 French 61-3005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- VCARE 60-6085-202AConmed Corporation · Cannula, manipulator/injector, uterine46 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.