Dover 8944MFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521050648), received between Nov 20, 2019 and Oct 27, 2020 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THERE WAS DIFFICULTY REMOVING THE CATHETER. THE BALLOON APPEARED TO BE UNABLE TO DEFLATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744303 ↗
• MalfunctionOct 27, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON IS UNABLE TO DEFLATE. THE ISSUE WAS FOUND BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 10741858 ↗
• InjurySep 22, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT WATER WAS ABLE TO BE PULLED OUT OF THE BALLOON WHEN ATTEMPTING TO REMOVE THE CATHETER, HOWEVER, THE CATHETER WAS UNABLE TO BE REMOVED. THEY REPEATED THE PROCESS OF REMOVING THE WATER USING A SYRINGE SEVERAL TIMES AND THE CATHETER STILL COULD NOT BE REMOVED. THE CATHETER WAS CUT AND AN ATTEMPT WAS MADE TO REMOVE IT, HOWEVER, IT COULD NOT BE REMOVED. THE CATHETER WAS FINALLY REMOVED USING A CYSTOSCOPE AND MAKING THE BALLOON DEFLATE. AN MRI AND THE CYSTOSCOPE CONFIRMED THERE WAS AIR IN THE BALLOON. THE CATHETER WAS INSERTED ON (B)(6) 2020 WITH NO ISSUE. NO SALINE OR OTHER CHEMICALS WERE USED DURING THE INSERTION. ADDITIONAL INFORMATION RECEIVED ON 24-SEP-2020 STATED THAT THE CATHETER WAS NOT TESTED PRIOR TO INSERTION. THERE WAS NO MEDICATION GIVEN TO THIS PATIENT RELATED TO THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES CHOLANGIOCELLULAR CARCINOMA, INTRAHEPATIC METASTASIS, AND PULMONARY METASTASIS. THE PATIENT WAS RECEIVING GEMZAR AND CISPLATIN ADMINISTRATION FOR TREATMENT. THE PATIENT ALSO HAD A PAST MEDICAL HISTORY OF DIABETES AND HYPERTENSION. THE PATIENT EXPIRED DUE TO THE PRIMARY DISEASE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10567505 ↗
• MalfunctionApr 27, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT AT PRE-INSERTION BALLOON CHECK, STERILE WATER WOULD NOT COME OUT FROM THE BALLOON AND THE BALLOON WOULD NOT DEFLATE.

  Patient problems: No Patient Involvement

  MAUDE report 10003347 ↗
• MalfunctionJan 7, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON WAS UNABLE TO DEFLATE DURING INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558429 ↗
• MalfunctionDec 20, 2019Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE WATER WAS UNABLE TO BE REMOVED FROM THE BALLOON. THE ISSUE OCCURRED PRIOR TO PATIENT USE DURING TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 9506372 ↗
• MalfunctionNov 20, 2019Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE WATER IN THE BALLOON WAS UNABLE TO BE REMOVED. THE ISSUE WAS NOTICED DURING PREPARATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9350342 ↗