Cook G30397Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002303973), received between May 30, 2018 and Dec 10, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2020Deflation Problem; Deflation Problem

  AS REPORTED, DURING A HYSTEROSALPINGOGRAM(HSG) PROCEDURE USING A INTRAUTERINE ACCESS BALLOON CATHETER, CONTRAST MEDIUM WAS LEAKING FROM THE FLO-CHECK VALVE. AFTER THE PROCEDURE, THE 2ML INFLATED BALLOON COULD NOT BE DEFLATED. THE USER USED THE CATHETER STYLET TO DEPRESS THE INFLATION PORT VALVE. THE SALINE THEN STARTED FLOWING OUT AND THE BALLOON DEFLATED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT. NO DEVICE REMAIN INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10988090 ↗
• MalfunctionMay 30, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE INTRAUTERINE ACCESS BALLOON CATHETER WOULD NOT DEFLATE. ANOTHER NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE 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.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7554215 ↗