Cook G17080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002170803), received between Sep 14, 2016 and Jan 3, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT IS REPORTED THAT WHILE PREPARING FOR AN UNSPECIFIED PROCEDURE USING A BALLOON UTERINE STENT, THE END USER OPENED THE PACKAGE TO INSPECT THE DEVICE PRIOR TO USE AND FOUND AN UNKNOWN BLACK STAIN ON THE BALLOON. THIS DEVICE WAS NOT USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214403 ↗
• InjurySep 14, 2016Deflation Problem; Deflation Problem

  IT WAS REPORTED ON (B)(6) 2016 A PHYSICIAN PERFORMED AN OPEN MYOMECTOMY USING AN INTRAUTERINE BALLOON STENT. THE DEVICE WAS REPORTED TO HAVE BEEN TESTED BY INFLATING AND DEFLATING THE BALLOON PRIOR TO INSERTION AND THE DOCTOR EXPERIENCED DIFFICULTY DEFLATING THE BALLOON, HAVING TO USE MORE FORCE AND TWISTING WITH THE SYRINGE TO OPEN THE VALVE AND RELEASE THE FLUID. ON (B)(6), 24 HOURS AFTER INSERTING THE DEVICE, THE PHYSICIANS MADE THE FIRST UNSUCCESSFUL ATTEMPT TO REMOVE THE DEVICE USING THE SYRINGE. THE DOCTOR ATTEMPTED TO DEFLATE THE BALLOON FOR APPROXIMATELY 30 MINUTES USING EXCESSIVE FORCE, TWISTING, CUTTING THE VALVE OFF AND TRYING A DIFFERENT SYRINGE. SUPPORT WAS CALLED AND THE HOSPITAL STAFF WAS ADVISED BY THE MANUFACTURER TO USE ULTRASOUND TO DETERMINE THE BALLOON VOLUME AND APPLY LUBRICATION. THREE HOURS LATER THE ATTENDING PHYSICIAN'S PARTNER CALLED SUPPORT AND REPORTED THE BALLOON WAS APPARENTLY FULLY INFLATED AND SHE COULD SEE THE BALLOON WHEN TRYING TO MANIPULATE IT. AT THIS TIME THE PARTNER SUGGESTED PUNCTURING THE BALLOON WITH A NEEDLE. THE PHYSICIAN ADMINISTERED A PUDENDAL BLOCK AND CERVICAL BLOCK ON THE PATIENT FOR PAIN AND USING A PUDENDAL NEEDLE WAS ABLE TO PUNC

  Patient problems: Anxiety; No Code Available; Pain

  MAUDE report 5948799 ↗