Cook G17471Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002174719), received between Apr 18, 2016 and Apr 20, 2021 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (9 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

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING A HYSTEROSALPINGOGRAM IN THE UTERINE CAVITY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LEAKED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692792 ↗
• MalfunctionApr 20, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING A HYSTEROSALPINGOGRAM IN THE UTERINE CAVITY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LEAKED AFTER INFLATION WITH 1.5ML SALINE. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692428 ↗
• MalfunctionMar 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  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 11411389 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING A HYSTEROSALPINGOGRAM, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE DEVICE WAS INITIALLY REPORTED TO HAVE LEAKED AFTER INJECTION OF 1.5ML SALINE USING THE PROVIDED SYRINGE. UPON RETURN EVALUATION OF THE DEVICE 21JAN2021, THE BALLOON WAS OBSERVED TO BE RUPTURED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Information

  MAUDE report 11259370 ↗
• MalfunctionJul 9, 2020Deflation Problem; Deflation Problem

  IT IS REPORTED DURING A HYSTEROSALPINGOGRAPHY PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE PHYSICIAN HAD DIFFICULTY WITH DEFLATING THE BALLOON. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE . NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. 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 10251868 ↗
• MalfunctionJun 24, 2020Deflation Problem; Deflation Problem

  IT WAS INITIALLY REPORTED, DURING A HYSTEROSALPINGOGRAM (HSG), USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE DEVICE WAS INFLATED WITH 1.5ML OF STERILE SALINE WHEN THE USER DISCOVERED THE BALLOON WAS LEAKING. A NEW DEVICE WAS USED TO COMPLETE THIS DIFFICULT PROCEDURE. THE PATIENT DID NOT HAVE ANY DISCOMFORT PERSISTING AFTER THE EXAMINATION. ADDITIONAL INFORMATION WAS RECEIVED 05JUN2020: THE BALLOON WAS LEAKING NEAR THE SIDE PORT. THE PHYSICIAN ADVISED, SOMETIMES IT WAS DIFFICULT TO INJECT THE CONTRAST, MAKING THE PROCEDURE DIFFICULT. THE DEVICE WAS RETURNED ON 11JUN2020 AND INSPECTION OF THE DEVICE FOUND THE BALLOON WAS RUPTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10190043 ↗
• MalfunctionOct 15, 2019Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 17OCT2019: IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING A DIFFERENT SYRINGE AND THE SAME BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192525 ↗
• MalfunctionMar 4, 2019Deflation Problem; Deflation Problem

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387258 ↗
• MalfunctionDec 5, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTEROSALPINGOGRAPHY (HSG) PROCEDURE, SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WOULD NOT DEFLATE BEFORE REMOVING FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134001 ↗
• MalfunctionDec 5, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTEROSALPINGOGRAPHY (HSG) PROCEDURE, SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WOULD NOT DEFLATE BEFORE REMOVING FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133973 ↗
• MalfunctionDec 5, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTEROSALPINGOGRAPHY (HSG) PROCEDURE, SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WOULD NOT DEFLATE BEFORE REMOVING FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133739 ↗
• MalfunctionDec 5, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTEROSALPINGOGRAPHY (HSG) PROCEDURE, SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WOULD NOT DEFLATE BEFORE REMOVING FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133517 ↗
• MalfunctionDec 5, 2018Deflation Problem

  IT WAS REPORTED THAT THE SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WAS PLACED INSIDE THE PATIENT AND INFLATED AS EXPECTED BUT WOULD NOT DEFLATE AFTER THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS PULLED THROUGH THE CERVIX. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8132849 ↗
• MalfunctionApr 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE INITIAL REPORTER INDICATED THAT THE BALLOONS COULD NOT BE UNBLOCKED AND THE CATHETERS HAD TO BE CUT TO ALLOW THE SODIUM CHLORIDE OUT OF THE BALLOON SO THE CATHETER COULD BE REMOVED. THERE WAS NO DESCRIPTION PROVIDED OF WHERE THE CATHETER WAS CUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490846 ↗
• MalfunctionApr 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE INITIAL REPORTER INDICATED THAT THE BALLOONS COULD NOT BE UNBLOCKED AND THE CATHETERS HAD TO BE CUT TO ALLOW THE SODIUM CHLORIDE OUT OF THE BALLOON SO THE CATHETER COULD BE REMOVED. THERE WAS NO DESCRIPTION PROVIDED OF WHERE THE CATHETER WAS CUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490758 ↗
• MalfunctionApr 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE INITIAL REPORTER INDICATED THAT THE BALLOONS COULD NOT BE UNBLOCKED AND THE CATHETERS HAD TO BE CUT TO ALLOW THE SODIUM CHLORIDE OUT OF THE BALLOON SO THE CATHETER COULD BE REMOVED. THERE WAS NO DESCRIPTION PROVIDED OF WHERE THE CATHETER WAS CUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6487272 ↗
• MalfunctionApr 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE INITIAL REPORTER INDICATED THAT THE BALLOONS COULD NOT BE UNBLOCKED AND THE CATHETERS HAD TO BE CUT TO ALLOW THE SODIUM CHLORIDE OUT OF THE BALLOON SO THE CATHETER COULD BE REMOVED. THERE WAS NO DESCRIPTION PROVIDED OF WHERE THE CATHETER WAS CUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6485407 ↗
• InjuryMar 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE INITIAL REPORTER INDICATED THAT THE BALLOONS COULD NOT BE UNBLOCKED AND THE CATHETERS HAD TO BE CUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450563 ↗
• InjuryApr 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HYSTEROSALPINGOGRAPHY PROCEDURE WAS BEING PERFORMED. AFTER INFLATION OF THE DEVICE, DIFFICULTY WAS EXPERIENCED WHEN THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE FROM THE PATIENT'S BODY. THE DOCTOR HAD TO CUT THE DEVICE FOR IT TO BE RELEASED AND TAKEN OUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5584711 ↗