Cook G17870Recalls & reported problems
Cook Incorporated · Cook, Silicone Balloon HSG Catheter · Class 2
Quick summary
This Cook Silicone Balloon HSG catheter is used to inflate a balloon inside the uterus to check the fallopian tubes. There are 44 adverse event reports, with no deaths and one injury described. Most reports describe the balloon failing to deflate or bursting, sometimes found before use or separating, and in nearly all cases the patient was not affected. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00827002178700), received between Feb 9, 2018 and Jan 9, 2025 — classified as 1 injury, 43 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (25 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
- Deflation Problem25
- Material Rupture17
- Device Contaminated During Manufacture or Shipping1
- Material Separation1
- Suction Problem1
Patient problems
- No Consequences Or Impact To Patient22
- No Clinical Signs, Symptoms or Conditions14
- No Patient Involvement4
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque1
- Discomfort1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Device Contaminated During Manufacture or Shipping; 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111817 ↗MalfunctionDec 16, 2021Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13017439 ↗MalfunctionDec 12, 2021Material Rupture; Material Rupture
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 12981901 ↗MalfunctionDec 8, 2021Material Rupture; Material Rupture
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12962801 ↗MalfunctionDec 8, 2021Material Rupture; Material Rupture
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12962737 ↗MalfunctionDec 8, 2021Material Rupture; Material Rupture
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12961381 ↗MalfunctionDec 2, 2021Material Rupture; Material Rupture
AS REPORTED, THE OPERATOR CHECKED THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER PRIOR TO USE AND DISCOVERED THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12920865 ↗MalfunctionDec 2, 2021Material Rupture; Material Rupture
AS REPORTED, THE OPERATOR CHECKED THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER PRIOR TO USE AND DISCOVERED THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12920725 ↗MalfunctionAug 13, 2021Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12320460 ↗MalfunctionJun 11, 2021Material Rupture; Material Rupture
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 11982859 ↗MalfunctionMay 6, 2021Material Rupture; Material Rupture
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 11782635 ↗MalfunctionApr 30, 2021Material Rupture; Material Rupture
AS REPORTED, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED IN THE PATIENT WHEN INFLATED WITH 1.3ML SALINE. THE DEVICE WAS NOT TESTED PRIOR TO USE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11755620 ↗MalfunctionApr 20, 2021Material Rupture; Material Rupture
AS REPORTED, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LEAKED DURING AN UNSPECIFIED PROCEDURE. THE LEAKAGE OCCURRED AT THE JOINT OF THE INFLATION PORT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11692706 ↗MalfunctionFeb 2, 2021Material Rupture; Material Rupture
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; No Consequences Or Impact To Patient
MAUDE report 11269713 ↗MalfunctionJan 6, 2021Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11122958 ↗MalfunctionJan 29, 2020Deflation Problem; Deflation Problem
NO ADDITIONAL PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9641546 ↗MalfunctionJan 27, 2020Deflation Problem; Deflation Problem
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9631381 ↗MalfunctionJan 27, 2020Deflation Problem; Deflation Problem
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9631285 ↗MalfunctionDec 19, 2019Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION HAS BEEN PROVIDED SINCE THE LAST REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9497014 ↗MalfunctionNov 1, 2019Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED ON 14NOV2019: A HYSTEROSONOGRAPHY PROCEDURE WAS BEING PERFORMED. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9267928 ↗MalfunctionAug 12, 2019Deflation Problem; Deflation Problem
UPDATE 21AUG2019: THE PROCEDURE BEING PERFORMED WAS A SONOISTEROSALPINGOGRAPHY IN VAGINA, CERVIX, AND UTERUS. 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 Consequences Or Impact To Patient
MAUDE report 8884043 ↗MalfunctionAug 12, 2019Deflation Problem; Deflation Problem
UPDATE 21AUG2019: THE PROCEDURE BEING PERFORMED WAS A SONOISTEROSALPINGOGRAPHY IN VAGINA, CERVIX, AND UTERUS. 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 Consequences Or Impact To Patient
MAUDE report 8883918 ↗MalfunctionAug 12, 2019Deflation Problem; Deflation Problem
UPDATE (B)(6) 2019: THE PROCEDURE BEING PERFORMED WAS A SONOISTEROSALPINGOGRAPHY IN VAGINA, CERVIX, AND UTERUS. 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 Consequences Or Impact To Patient
MAUDE report 8883830 ↗MalfunctionAug 12, 2019Deflation Problem; Deflation Problem
NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8883733 ↗MalfunctionAug 12, 2019Deflation Problem; Deflation Problem
IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE USING AN COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THERE WAS DIFFICULTY DEFLATING THE BALLOON. EVENTUALLY THE USER WAS ABLE TO DEFLATE THE BALLOON. THERE WERE MORE THAN ONE OCCURRENCE OF THIS TYPE OF EVENT. (PATIENT REFERENCE IDENTIFIER (B)(6)) ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE PATIENT AND EVENT. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8883634 ↗
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.