Goldstein G17149Recalls & reported problems
Cook Incorporated · Goldstein Sonohysterography Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002171497), received between Jun 22, 2020 and Jun 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2020Material Separation
THE PATIENT UNDERWENT A SONO-HYSTEROGRAM USING A GOLDSTEIN CATHETER. AT THE TIME OF THE CATHETER REMOVAL, THE WHITE PLASTIC POSITIONER CATHETER TIP WAS NOT REMOVED AT THE SAME TIME THAT THE CATHETER WAS REMOVED AND REMAINED IN THE PATIENT'S VAGINA. THE PATIENT SELF-REMOVED THE POSITIONER CATHETER TIP LATER AFTER THE PROCEDURE AND NOTIFIED THE PHYSICIAN. CONCERN HAS BEEN RAISED THAT THIS PRODUCT IS COMPRISED OF TWO PIECES THAT CAN BE SEPARATED AND HAVE NO SAFETY MECHANISM TO KEEP THE TWO PIECES TOGETHER AND THAT THERE ARE PRODUCTS THAT DO NOT SEPARATE THAT MAY BE SAFER FOR PATIENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10178355 ↗
Other Cannula, manipulator/injector, uterine devices
- VCARE 60-6085-201AConmed Corporation · Cannula, manipulator/injector, uterine198 reports
- Cook G17147Cook Incorporated · Cannula, manipulator/injector, uterine68 reports
- Mckesson 11-19611Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Catheter with Integrated Stylet • 5 French 61-3005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter • 5 French 61-4005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- Mckesson 11-19610Mckesson 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
- VCARE 60-6085-202AConmed Corporation · Cannula, manipulator/injector, uterine46 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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