Cook G17472Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002174726), received between Oct 13, 2016 and Nov 23, 2021 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (17 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862163 ↗
• MalfunctionNov 7, 2021Deflation Problem; Deflation Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760137 ↗
• MalfunctionApr 22, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING A HYSTEROSALPINGOGRAPHY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE BALLOON WAS INJECTED WITH 0.5ML SALINE USING THE SYRINGE INCLUDED WITH THE DEVICE, BUT THE DEVICE COULD NOT BE CLEARLY SEEN UNDER SONOGRAPHY. ANOTHER 0.5ML WAS INJECTED AND THE BALLOON COULD STILL NOT BE SEEN. NO SALINE WAS UNABLE TO BE EXTRACTED FROM THE DEVICE, SO THE USER REMOVED THE DEVICE AND DISCOVERED THE BALLOON WAS BROKEN. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712278 ↗
• MalfunctionDec 29, 2020Deflation Problem; Deflation Problem

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11090042 ↗
• MalfunctionDec 5, 2018Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO USE THE SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON HAD DIFFICULTIES IN INFLATION AND DEFLATION. THE BALLOONS WOULD EITHER NOT INFLATE, OR WOULD INFLATED BUT IT WOULD NOT DEFLATE AFTER. 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 8136253 ↗
• MalfunctionDec 5, 2018Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO USE THE SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON HAD DIFFICULTIES WITH INFLATION AND DEFLATION. THE BALLOONS WOULD EITHER NOT INFLATE, OR WOULD INFLATE BUT IT WOULD NOT DEFLATE AFTER. 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 8136230 ↗
• MalfunctionDec 5, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE SONOHYSTEROGRAPHY, THE SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WAS DIFFICULT TO DEFLATE WHEN INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON RESISTED DEFLATION, IT INCREASED TEST TIME AND THE PATIENT EXPERIENCED INCREASED DISCOMFORT UPON CATHETER REMOVAL FROM THE UTERUS. THIS WAS REPORTED TO HAVE OCCURRED ON MULTIPLE PATIENTS.

  Patient problems: Discomfort

  MAUDE report 8132739 ↗
• MalfunctionDec 4, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTEROSALPINGOGRAM, THE SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WOULD NOT DEFLATE WHEN INSIDE THE PATIENT. AFTER MULTIPLE ATTEMPTS, IT EVENTUALLY DEFLATED AND WAS REMOVED 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 8129002 ↗
• MalfunctionDec 4, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTEROSALPINGOGRAM, THE SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WOULD NOT DEFLATE WHEN INSIDE THE PATIENT. AFTER MULTIPLE ATTEMPTS, IT EVENTUALLY DEFLATED AND WAS REMOVED FROM THE PATIENT. THIS OCCURRED DURING ONE PROCEDURE (B)(6) 2015 AND DURING 3 OTHER RECENT PROCEDURES ON UNKNOWN DATES WITH THE SAME LOT. 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 8128909 ↗
• MalfunctionDec 4, 2018Deflation Problem

  IT WAS REPORTED THAT DURING THE HYSTERO SALPINOGRAM PROCEDURE, THE SILICONE BALLOON (QUANTITY 5) WOULD INFLATE BUT FAILED TO DEFLATE. 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 8128642 ↗
• MalfunctionDec 4, 2018Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE HYSTERO SALPINOGRAM PROCEDURE, THE PHYSICIAN HAD THE DIFFICULTY WITH THE INFLATING AND DEFLATING SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE DEVICE WAS TESTED BEFORE USING ON THE PATIENT, HOWEVER, DIFFICULTIES OCCURRED DURING THE PROCEDURE CAUSED PAIN AND DISCOMFORT TO THE PATIENT. THERE WERE NO OTHER 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 8128341 ↗
• MalfunctionDec 4, 2018Deflation Problem; Inflation Problem

  IT WAS REPORTED DURING THE SONOHYSTEROGRAM PROCEDURE, THE FIRST SILICONE BALLOON WAS UNABLE TO INFLATE. IT WAS ALSO REPORTED THAT THE SECOND BALLOON WAS UNABLE TO DEFLATE. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128275 ↗
• MalfunctionDec 4, 2018Inflation Problem

  IT WAS REPORTED DURING THE SONOHYSTEROGRAM PROCEDURE, THE FIRST SILICONE BALLOON WAS UNABLE TO INFLATE. IT WAS ALSO REPORTED THAT THE SECOND BALLOON WAS UNABLE TO DEFLATE. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128163 ↗
• MalfunctionSep 25, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON FAILED TO DEFLATE AFTER THE INITIAL INFLATION. THIS DID NOT CREATE ANY PROBLEMS DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. IT WAS CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THIS ISSUE WAS REPORTED TO HAVE OCCURRED SOMETIME IN (B)(6) 2018. THE CUSTOMER COULD NOT CONFIRM THE EXACT DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907212 ↗
• MalfunctionSep 25, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON FAILED TO DEFLATE AFTER THE INITIAL INFLATION. THIS DID NOT CREATE ANY PROBLEMS DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. IT WAS CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THIS ISSUE WAS REPORTED TO HAVE OCCURRED SOMETIME IN (B)(6) 2018. THE CUSTOMER COULD NOT CONFIRM THE EXACT DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907162 ↗
• MalfunctionSep 25, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON FAILED TO DEFLATE AFTER THE INITIAL INFLATION. THIS DID NOT CREATE ANY PROBLEMS DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. IT WAS CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907159 ↗
• MalfunctionMar 27, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED DURING PREOPERATIVE TESTING, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER FAILED TO DEFLATE. AFTER SEVERAL ATTEMPTS THE DEVICE WAS SUCCESSFULLY DEFLATED, HOWEVER, THE CUSTOMER OPENED A NEW DEVICE TO COMPLETE THE SCHEDULED SONOHYSTEROGRAM SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 1820334-2018-00809 AS THE SAME ISSUE WAS OBSERVED ON A SAME-LOT DEVICE USED IN A DIFFERENT CASE.

  Patient problems: No Patient Involvement

  MAUDE report 7374318 ↗
• MalfunctionMar 27, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED DURING PREOPERATIVE TESTING, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER FAILED TO DEFLATE. AFTER SEVERAL ATTEMPTS THE DEVICE WAS SUCCESSFULLY DEFLATED, HOWEVER, THE CUSTOMER OPENED A NEW DEVICE TO COMPLETE THE SCHEDULED SONOHYSTEROGRAM SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 1820334-2018-00810 AS THE SAME ISSUE WAS OBSERVED ON A SAME-LOT DEVICE USED IN A DIFFERENT CASE.

  Patient problems: No Patient Involvement

  MAUDE report 7374230 ↗
• MalfunctionNov 1, 2017Deflation Problem; Deflation Problem

  THE DISTRIBUTOR REPORTED DURING A SONOHYSTEROGRAM PROCEDURE, THE CUSTOMER TRIED TO USE TWO COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOONS BUT THEY WOULD NOT INFLATE. WHILE TESTING THREE ADDITIONAL COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOONS FROM LOT 7605237, THEY INJECTED EACH WITH AIR USING A 1ML SYRINGE. THE BALLOONS WOULD DEFLATE DURING TESTING AND WERE NOT USED ON THE PATIENT. THE CUSTOMER ADVISED, THEY TESTED ONE ADDITIONAL BALLOON FROM LOT 7613144 AND IT ALSO WOULD NOT DEFLATE. THE CUSTOMER ADVISED THE PROCEDURE WAS COMPLETED WITH LIMITED ULTRASOUND IMAGE RESULTS. AS REPORTED THERE WAS NO HARM OR ADVERSE EFFECT TO THE PATIENT DUE TO THESE OCCURRENCES. NO ADDITIONAL PROCEDURES WERE REQUIRED. TWO MANUFACTURER REPORTS ARE BEING FILED FOR THIS EVENT. MFR. REPORT # 1820334-2017-03753 CAPTURES THREE (3) BALLOONS FROM LOT 7605237 THAT WOULD NOT DEFLATE DURING TESTING, AND MFR. REPORT #1820334-2017-03754 CAPTURES THE ONE (1) BALLOON FROM LOT 7613144 THAT ALSO DID NOT DEFLATE DURING TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6992819 ↗
• MalfunctionNov 1, 2017Deflation Problem; Deflation Problem

  THE DISTRIBUTOR REPORTED DURING A SONOHYSTEROGRAM PROCEDURE, THE CUSTOMER TRIED TO USE TWO COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOONS BUT THEY WOULD NOT INFLATE. WHILE TESTING THREE ADDITIONAL COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOONS FROM LOT 7605237, THEY INJECTED EACH WITH AIR USING A 1ML SYRINGE. THE BALLOONS WOULD DEFLATE DURING TESTING AND WERE NOT USED ON THE PATIENT. THE CUSTOMER ADVISED, THEY TESTED ONE ADDITIONAL BALLOON FROM LOT 7613144 AND IT ALSO WOULD NOT DEFLATE. THE CUSTOMER ADVISED THE PROCEDURE WAS COMPLETED WITH LIMITED ULTRASOUND IMAGE RESULTS. AS REPORTED THERE WAS NO HARM OR ADVERSE EFFECT TO THE PATIENT DUE TO THESE OCCURRENCES. NO ADDITIONAL PROCEDURES WERE REQUIRED. TWO MANUFACTURER REPORTS ARE BEING FILED FOR THIS EVENT. MFR. REPORT # 1820334-2017-03753 CAPTURE THREE (3) BALLOONS FROM LOT 7605237 THAT WOULD NOT DEFLATE DURING TESTING, AND MFR. REPORT #1820334-2017-03754 TO CAPTURE THE ONE (1) BALLOON FROM LOT 7613144 THAT ALSO DID NOT DEFLATE DURING TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6992670 ↗
• MalfunctionJul 28, 2017Deflation Problem; Deflation Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A HYSTEROSALPINGOGRAPHY. THE CUSTOMER REPORTS THAT THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WOULD NOT DEFLATE. NO FURTHER EVENT INFORMATION WAS PROVIDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750228 ↗
• MalfunctionJul 21, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING TREATMENT, ONCE THE BALLOON WAS INFLATED WITH SALINE SOLUTION, THE BALLOON WOULD NOT DEFLATE. ONCE THE BALLOON IS INFLATED IT DOES NOT RETURN TO ITS NORMAL SHAPE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6733699 ↗
• MalfunctionApr 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT THE PHYSICIAN PERFORMED A HYSTEROSALPINGOGRAPHY PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE ATTENDING PHYSICIAN INDICATED THAT THE BALLOON WAS INFLATED TO LESS THAN THE MAX PRESSURE OF 1ML OF SALINE SOLUTION. THE PHYSICIAN ATTEMPTED TO RETRACT THE SALINE SOLUTION FROM THE BALLOON BUT IT WOULD NOT COME OUT AND THE BALLOON WOULD NOT DEFLATE. HENCE, THE BALLOON HAD TO BE REMOVED IN THE INFLATED STATE CAUSING PAIN TO THE PATIENT. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT RECEIVE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 6461383 ↗
• MalfunctionApr 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT THE PHYSICIAN PERFORMED A HYSTEROSALPINGOGRAPHY PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE ATTENDING PHYSICIAN INDICATED THAT THE BALLOON WAS INFLATED TO LESS THAN THE MAX PRESSURE OF 1ML OF SALINE SOLUTION. THE PHYSICIAN ATTEMPTED TO RETRACT THE SALINE SOLUTION FROM THE BALLOON BUT IT WOULD NOT COME OUT AND THE BALLOON WOULD NOT DEFLATE. HENCE, THE BALLOON HAD TO BE REMOVED IN THE INFLATED STATE CAUSING PAIN TO THE PATIENT. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT RECEIVE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 6461368 ↗
• MalfunctionApr 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE USER FACILITY THAT THE PHYSICIAN PERFORMED A HYSTEROSALPINGOGRAPHY PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. THE ATTENDING PHYSICIAN INDICATED THAT THE BALLOON WAS INFLATED TO LESS THAN THE MAX PRESSURE OF 1ML OF SALINE SOLUTION. THE PHYSICIAN ATTEMPTED TO RETRACT THE SALINE SOLUTION FROM THE BALLOON BUT IT WOULD NOT COME OUT AND THE BALLOON WOULD NOT DEFLATE. HENCE, THE BALLOON HAD TO BE REMOVED IN THE INFLATED STATE CAUSING PAIN TO THE PATIENT. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT RECEIVE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 6461337 ↗