Cook G17147Recalls & reported problems
Cook Incorporated · Cook, Silicone Balloon HSG Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Silicone Balloon HSG catheter is used to inflate a balloon inside the uterus to check the fallopian tubes during hysterosonography. The 68 reports mostly describe a balloon that will not inflate or will not deflate, and one that bursts or breaks, sometimes leaving a piece of the device inside the uterus. Most cases were completed with another catheter and no harm to the patient; there are no deaths and no injuries. No recalls name this device, and no reports have been filed in the last 12 months.
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
- 68
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00827002171473), received between Mar 31, 2016 and Apr 22, 2021 — classified as 68 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (44 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.
Most reported problems
Device problems
- Deflation Problem44
- Material Rupture18
- Inflation Problem10
- Device Operates Differently Than Expected6
- Difficult to Remove2
- Suction Problem2
- Difficult to Insert1
Patient problems
- No Consequences Or Impact To Patient33
- No Known Impact Or Consequence To Patient25
- No Clinical Signs, Symptoms or Conditions7
- Discomfort4
- No Patient Involvement3
- No Information1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2021Material Rupture; Material Rupture
AS REPORTED, DURING A HYSTEROSONOGRAPHY PROCEDURE, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE USING THE PROVIDED 1ML SYRINGE, AND BALLOON WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11709324 ↗MalfunctionApr 20, 2021Material Rupture; Material Rupture
AS REPORTED, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WOULD NOT INFLATE WHEN TESTED PRIOR TO USE IN A SONOHYSTEROGRAPHY. THE BALLOON WAS ATTEMPTED TO BE INFLATED WITH WATER WITH THE PROVIDED SYRINGE. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11692525 ↗MalfunctionMar 11, 2021Material Rupture; Material Rupture
AS REPORTED, DURING A HYCOSY PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE BALLOON BURST. WHILE THE PHYSICIAN WAS ATTEMPTING TO INFLATE THE BALLOON PRIOR TO INSERTION, IT BURST (REFERENCE PATIENT IDENTIFIER (B)(4)). HE TRIED ANOTHER CATHETER AND IT ALSO BURST AFTER INSERTION AND BROKE INSIDE OF THE UTERUS. THERE WAS NO HARM TO THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT THE BALLOON. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11464057 ↗MalfunctionMar 11, 2021Material Rupture; Material Rupture
AS REPORTED, DURING A HYSTEROSALPINGO-CONTRAST-SONOGRAPHY (HYCOSY) PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE BALLOON BURST. WHILE THE PHYSICIAN WAS ATTEMPTING TO INFLATE THE BALLOON PRIOR TO INSERTION, IT BURST. HE TRIED ANOTHER CATHETER AND IT ALSO BURST AFTER INSERTION AND BROKE INSIDE OF THE UTERUS (REFERENCE PATIENT IDENTIFIER (B)(6)). THERE WAS NO HARM TO THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT THE BALLOON. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11463788 ↗MalfunctionFeb 19, 2021Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11348097 ↗MalfunctionFeb 1, 2021Material Rupture; Material Rupture
AS REPORTED, WHILE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE BALLOON RUPTURED WHEN BEING INFLATED WITH A SYRINGE. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETED THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED RELATED TO THIS OCCURRENCE. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11259036 ↗MalfunctionFeb 1, 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 11258651 ↗MalfunctionAug 26, 2020Deflation Problem; Deflation Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10457384 ↗MalfunctionAug 4, 2020Material Rupture; Material Rupture
IT WAS REPORTED, DURING A HYSTEROSALPINGOGRAM-CONTRAST SONOGRAPHY (HYCOSY) USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE BALLOON BURST. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10364301 ↗MalfunctionAug 4, 2020Deflation Problem; Deflation Problem
IT IS REPORTED DURING A HYSTEROSALPINGOGRAM (HSG) PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, AFTER INFLATING THE DEVICE WITH AIR, THE USER HAD DIFFICULTY DEFLATING THE DEVICE TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE COMPLAINT DEVICE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT, AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND THE EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10362375 ↗MalfunctionJul 15, 2020Material Rupture; Material Rupture
IT IS REPORTED DURING A HYSTEROSALPINGO-CONTRAST SONOGRAPHY (HYCOSY) USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, WHILE THE BALLOON WAS INFLATED WITH 1ML OF SALINE USING THE PROVIDED SYRINGE, THE BALLOON BURST AND DID NOT INFLATE. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED AFTER THIS DIFFICULTY OCCURRED THE PATIENT DID NOT EXPERIENCE AND ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10277316 ↗MalfunctionJun 26, 2020Deflation Problem; Deflation Problem
ADDITIONAL INFORMATION PROVIDED (B)(6) 2020: THE DEVICE WAS INFLATED WITH 1ML OF NORMAL SALINE (NACL 0.9%) USING THE PROVIDED SYRINGE. THERE WERE NO DIFFICULTIES WITH INSERTING OR CONNECTING THE SYRINGE. THE DEVICE WAS NOT TESTED PRIOR TO USE. THERE WAS NO LEAKAGE REPORTED. THERE WAS NO ISSUE WITH THE PACKAGING, OR OPENING OF THE PACKAGE. THE PATIENT WAS NOT POSITIVE FOR COVID-19.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10199973 ↗MalfunctionJun 23, 2020Material Rupture; Material Rupture
IT WAS REPORTED, DURING A UTERINE ANGIOGRAPHY USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE OPERATOR PLACED THE DEVICE AND BEGAN TO INFLATE BUT NO CHANGE WAS OBSERVED. THE DEVICE WAS REMOVED, AND THE BALLOON WAS FOUND TO BE BROKEN. ON 02JUN2020, ADDITIONAL INFORMATION WAS RECEIVED THAT THE BALLOON HAD RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10184923 ↗MalfunctionJun 2, 2020Inflation Problem; Inflation Problem
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10110936 ↗MalfunctionFeb 18, 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 9721868 ↗MalfunctionDec 31, 2019Deflation Problem; Deflation Problem
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: Discomfort
MAUDE report 9535725 ↗MalfunctionDec 5, 2019Deflation Problem; Deflation Problem
ADDITIONAL INFORMATION RECEIVED 10DEC2019: THE BALLOON WAS INFLATED WITH AIR TO THE VOLUME USING THE 1 ML SYRINGE PROVIDED. THE DEVICE WAS NOT TESTED PRIOR TO INSERTING IT INTO THE BALLOON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9416438 ↗MalfunctionOct 22, 2019Material Rupture; Material Rupture
IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE IN WHICH A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WAS USED, THAT PRIOR TO PATIENT CONTACT, WHEN FILLING THE BALLOON IT RUPTURED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9218559 ↗MalfunctionOct 22, 2019Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 22OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9218495 ↗MalfunctionOct 22, 2019Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9218430 ↗MalfunctionOct 22, 2019Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 22OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9218372 ↗MalfunctionOct 22, 2019Material Rupture; Material Rupture
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9218299 ↗MalfunctionOct 15, 2019Material Rupture; Material Rupture
NO ADDITIONAL PATIENT OR EVEN INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 31OCT2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9192586 ↗MalfunctionOct 15, 2019Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 31OCT2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9191597 ↗MalfunctionSep 16, 2019Difficult to Remove; Difficult to Remove
DURING AN UNSPECIFIED PROCEDURE, FOUR COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WERE USED. THE COMPLAINANT STATED THE BALLOON WOULD INFLATE, BUT THAT WHEN THE PROCEDURE WAS FINISHED IT WOULD NOT DEFLATE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF THE REQUESTED INFORMATION IS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9072300 ↗
Other Cannula, manipulator/injector, uterine devices
- VCARE 60-6085-201AConmed Corporation · Cannula, manipulator/injector, uterine198 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
- Cook G17870Cook Incorporated · Cannula, manipulator/injector, uterine44 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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