Goldstein G18664Recalls & reported problems
Cook Incorporated · Goldstein Sonohysterography Catheter · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002186644), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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
- Improper or Incorrect Procedure or Method2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED A FEMALE PATIENT UNDERWENT A SONOHYSTEROGRAM PROCEDURE ON (B)(6) 2025 IN WHICH THE GOLDSTEIN SONOHYSTEROGRAPHY CATHETER WAS USED. THE ACORN PIECE CAME OFF INSIDE THE PATIENT. THE PATIENT REPORTED TO THE PHYSICIAN´S OFFICE THAT THE ACORN PIECE HAD BEEN EXPELLED AT HOME ON (B)(6) 2025. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient
MAUDE report 21883416 ↗MalfunctionApr 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED A FEMALE PATIENT UNDERWENT A SONOHYSTOGRAM PROCEDURE ON (B)(6) 2025 IN WHICH THE GOLDSTEIN SONOHYSTEROGRAPHY CATHETER WAS USED. THE ACORN PIECE CAME OFF INSIDE THE PATIENT. THE PATIENT REPORTED TO THE PHYSICIAN´S OFFICE THAT THE ACORN PIECE HAD BEEN EXPELLED AT HOME ON (B)(6) 2025. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient
MAUDE report 21883197 ↗
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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.