Goldstein G19012Recalls & reported problems
Cook Incorporated · Goldstein Sonohysterography Catheter · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002190122), received between Aug 3, 2016 and Jul 9, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 19703831 ↗MalfunctionNov 15, 2022Adverse Event Without Identified Device or Use Problem
PATIENT CALLED IN THIS MORNING TO INFORM STAFF THAT A "LITTLE RUBBER ACORN SHAPED OBJECT FELL OUT OF HER" AND SHE WAS CONCERNED IT WAS LEFT BEHIND FROM THE HSF PROCEDURE AND WAS WORRIED MORE MAY BE LEFT BEHIND.
Patient problems: Foreign Body In Patient
MAUDE report 15797126 ↗InjuryAug 3, 2016Break; Break
PER THE MW5062932, REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT THE OB/GYN PERSONNEL INSERTED A SALINE INFUSION SONOGRAPHY CATHETER INTO THE FEMALE PATIENT FOR ULTRASOUND. THE DEVICE WAS REMOVED AND PATIENT WAS SENT HOME. THE FOLLOWING DAY, THE PATIENT REPORTED THAT A PIECE OF WHITE PLASTIC FELL OUT OF HER VAGINA. PATIENT RETURNED TO OFFICE TO REPORT AND WAS VERY ANGRY THAT A PIECE OF THE CATHETER WAS LEFT IN HER TO FALL OUT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5843993 ↗
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 11-19610Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- 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.